Digestive Disease Week (DDW 2011)

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – Proton pump inhibitor use was significantly associated with hypomagnesemia in a large, retrospective analysis of 1,317 hospitalized adults.

The potential effects of PPI use on serum magnesium levels did not appear to be dose related, Dr. Jen-Tzer Gau and his colleagues reported at the annual Digestive Disease Week.

In a safety announcement released in earlier this year, the Food and Drug Administration warned that prolonged use of prescription proton pump inhibitors (PPIs) can reduce magnesium levels, possibly leading to serious adverse events including tetany, arrhythmias, and seizures.

The agency recommends that providers obtain serum magnesium levels prior to initiating PPI therapy, and then periodically check levels in patients who are on prolonged PPI treatment or who take PPIs with digoxin or drugs such as diuretics that may cause hypomagnesemia.

The safety alert was based on 38 cases in the Adverse Event Reporting System and 23 cases in the literature (at least 8 of which were included in the 38 in AERS), and it notes that hypomagnesemia is likely underrecognized and underreported.

The current study involved 1,317 patients at a rural community hospital in southeast Ohio, of whom 464 were PPI users and 853 were not. Hypomagnesemia was defined as a magnesium level of less than 1.7 mg/dL.

The mean magnesium level on admission was 1.91 mg/dL among PPI users, compared with 2.00 mg/dL among nonusers (P = .004), said Dr. Gau, chair of geriatric medicine/gerontology at Ohio University College of Osteopathic Medicine in Athens. PPI users and nonusers were similar with regard to age (mean 73 years), gender (62% female), past smoking history (roughly 22%), length of stay (mean 4.5 days), and discharge diagnosis, although PPI users had significantly more GI illness, as would be expected (31% vs. 26%, P = .02).

In logistic regression analyses, PPI therapy was associated with an increased risk of hypomagnesemia occurrence (crude odds ratio 2.41), and the association remained significant after adjustment for all confounders (OR 2.41, 95% confidence interval 1.34-4.34), Dr. Gau said.

The odds ratio was 2.29 after adjustment for age, sex, and serum albumin levels (model 1; 95% CI 1.35-3.89) and was 2.21 after researchers also adjusted for serum levels of potassium, calcium, and creatinine; supplementation with potassium and magnesium; history of diabetes and chronic obstructive pulmonary disease; and diuretic use (model 2; 95% CI 1.27-3.85). The fully adjusted model included all of the above variables plus history of heart failure and coronary artery disease, a diagnosis of acute GI illness, and use of iron supplements, antipsychotics, antihistamines, narcotics, NSAIDs, antidepressants, beta2-agonist bronchodilators, inhaled corticosteroids, and oral laxatives.

In an analysis of variance that evaluated PPI dosage, the mean magnesium level was 2.0 mg/dL with a defined daily dose (DDD) of 0, 1.89 mg/dL with a DDD of 1, and 1.92 mg/dL with a DDD of 2 or more (P = .026), Dr. Gau said.

In a regression analysis, however, no significant association between hypomagnesemia and PPI use was observed for the higher PPI dose compared with no PPI use (DDD 2 or more vs. DDD 0) in the adjusted model 2 (OR 1.80; CI 0.98-3.30). Otherwise, there were significant associations observed in the rest of the models between hypomagnesemia and PPI use.

During a discussion of the study at the meeting, an attendee asked why the association with hypomagnesemia was not more profound at higher levels of PPI use. Dr. Gau replied that the finding that both higher and lower DDD units appeared to significantly increase the risk for hypomagnesemia is consistent with other case reports suggesting that it was a non–dose related or time-related adverse drug reaction.

Patients with lower serum albumin levels had significantly lower magnesium levels and an increased risk for hypomagnesemia (adjusted OR 2.31; CI 1.28-4.16). Dr. Gau said serum potassium levels were also associated with lower serum magnesium levels, but he did not provide specific data.

Limitations of the study include the fact that most of the patients were white, the lack of data on duration of PPI use (although most patients were probably long-term users), he said, and the potential for unmeasured confounders. The FDA noted that PPI-treated patients with reported hypomagnesemia had typically taken PPIs for more than 1 year.

Given the potential for additional confounders in a hospital-based population, one attendee suggested that a community-based cohort would have been more meaningful.

Dr. Gau said that future work should address the potential underlying mechanism for lower magnesium levels among PPI users. The exact mechanism is unknown, although it is thought that PPIs may interfere with magnesium absorption from the GI tract.

Dr. Gau and his coauthors reported no conflicts of interest.

CHICAGO – The investigational agent linaclotide brought relief from the symptoms of irritable bowel syndrome with constipation in a randomized phase III trial of 800 patients.

Linaclotide significantly improved all 4 primary efficacy end points and all 10 secondary efficacy end points when it was compared with placebo in the 16-week trial, Dr. Satish S.C. Rao reported at the annual Digestive Disease Week.

The study sponsors (Ironwood Pharmaceuticals and Forest Laboratories) reported that they are on track to submit a New Drug Application later this year to the Food and Drug Administration for the indications of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. European partner Almirall S.A. is expected to file for the IBS-C indication in Europe in the second half of 2011. During the 2-week pretreatment baseline period, patients in the study met modified Rome II criteria for IBS-C, and had an average of fewer than three complete spontaneous bowel movements (CSBMs) per week, and five or fewer spontaneous bowel movements per week, plus abdominal pain rated as a 3 or higher on a 10-point severity scale. Most (91%) of the 800 patients were female, and 77% were white. During the pretreatment period, 88% of patients experienced abdominal pain every day.

Patients were randomized to linaclotide 266 mcg or placebo (405 and 395 patients, respectively) once daily for 12 weeks, followed by a 4-week randomized withdrawal period during which the linaclotide group either continued on treatment or switched to placebo, and placebo patients switched to active treatment.

In all, 19.5% of patients on linaclotide were able to have at least three CSBMs and at least one additional bowel movement per week for at least 9 of 12 weeks, compared with only 6.3% of patients on placebo (P less than .0001), reported Dr. Rao, professor and director of neurogastroenterology and motility at the University of Iowa in Iowa City.

For at least 9 of 12 weeks, 34.3% of linaclotide-treated patients experienced at least a 30% reduction in abdominal pain, as did 27.1% of controls, a significant difference (P less than .05).

Both of these end points were achieved for at least 9 of 12 weeks by 12% of the linaclotide patients and 5% of controls (P less than .001).

The fourth primary end point, created by the FDA last year to provide guidance for the industry, required at least a 30% reduction in abdominal pain and an increase of at least one CSBM per week, both for at least 6 of 12 weeks. In all, 33.6% of the linaclotide patients and 21% of controls achieved this end point (P less than .0001).

The linaclotide group experienced significant improvements, compared with the placebo group, on all secondary end points including bloating severity scores, abdominal discomfort severity scores, CSBMs per week, and straining scores, he said.

Patients who continued on or switched to linaclotide improved, whereas patients who switched from linaclotide to placebo showed a relapse of symptoms.

Linaclotide is a 14–amino acid investigational peptide that increases generation of cyclic guanosine monophosphate (cGMP) in patients with IBS. Based on preclinical data, cGMP is thought to increase luminal fluid secretion and also to enhance intestinal transit and reduce visceral pain by modulating the activity of afferent nerves, Dr. Rao explained.

The only other FDA-approved drug for this disorder is lubiprostone (Amitiza), which is a chloride channel activator. The mechanism of action, efficacy, and adverse events associated with linaclotide appear to be different from those of lubiprostone, Dr. Rao said in an interview.

Diarrhea was the most common adverse event, occurring in 19.5% of linaclotide and 3.5% of placebo patients. Rates of other adverse events were similar with linaclotide and placebo, including abdominal pain (5.4% vs. 2.5%), headache (5% vs. 3.5%), and flatulence (5% vs. 1.5%).

Dr. Rao said that patients in clinical practice would need to remain on continuous linaclotide, but noted that a long-term study, also presented at DDW, included data for 6 months showing persistent improvement.

Ironwood Pharmaceuticals and Forest Laboratories sponsored the trial. Dr. Rao disclosed consulting and serving as an advisor or review panel member for Forest, Takeda Pharmaceuticals, and the Dannon Co. His coauthors reported financial relationships with Ironwood and Forest.

CHICAGO – The investigational agent linaclotide brought relief from the symptoms of irritable bowel syndrome with constipation in a randomized phase III trial of 800 patients.

Linaclotide significantly improved all 4 primary efficacy end points and all 10 secondary efficacy end points when it was compared with placebo in the 16-week trial, Dr. Satish S.C. Rao reported at the annual Digestive Disease Week.

The study sponsors (Ironwood Pharmaceuticals and Forest Laboratories) reported that they are on track to submit a New Drug Application later this year to the Food and Drug Administration for the indications of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. European partner Almirall S.A. is expected to file for the IBS-C indication in Europe in the second half of 2011. During the 2-week pretreatment baseline period, patients in the study met modified Rome II criteria for IBS-C, and had an average of fewer than three complete spontaneous bowel movements (CSBMs) per week, and five or fewer spontaneous bowel movements per week, plus abdominal pain rated as a 3 or higher on a 10-point severity scale. Most (91%) of the 800 patients were female, and 77% were white. During the pretreatment period, 88% of patients experienced abdominal pain every day.

Patients were randomized to linaclotide 266 mcg or placebo (405 and 395 patients, respectively) once daily for 12 weeks, followed by a 4-week randomized withdrawal period during which the linaclotide group either continued on treatment or switched to placebo, and placebo patients switched to active treatment.

In all, 19.5% of patients on linaclotide were able to have at least three CSBMs and at least one additional bowel movement per week for at least 9 of 12 weeks, compared with only 6.3% of patients on placebo (P less than .0001), reported Dr. Rao, professor and director of neurogastroenterology and motility at the University of Iowa in Iowa City.

For at least 9 of 12 weeks, 34.3% of linaclotide-treated patients experienced at least a 30% reduction in abdominal pain, as did 27.1% of controls, a significant difference (P less than .05).

Both of these end points were achieved for at least 9 of 12 weeks by 12% of the linaclotide patients and 5% of controls (P less than .001).

The fourth primary end point, created by the FDA last year to provide guidance for the industry, required at least a 30% reduction in abdominal pain and an increase of at least one CSBM per week, both for at least 6 of 12 weeks. In all, 33.6% of the linaclotide patients and 21% of controls achieved this end point (P less than .0001).

The linaclotide group experienced significant improvements, compared with the placebo group, on all secondary end points including bloating severity scores, abdominal discomfort severity scores, CSBMs per week, and straining scores, he said.

Patients who continued on or switched to linaclotide improved, whereas patients who switched from linaclotide to placebo showed a relapse of symptoms.

Linaclotide is a 14–amino acid investigational peptide that increases generation of cyclic guanosine monophosphate (cGMP) in patients with IBS. Based on preclinical data, cGMP is thought to increase luminal fluid secretion and also to enhance intestinal transit and reduce visceral pain by modulating the activity of afferent nerves, Dr. Rao explained.

The only other FDA-approved drug for this disorder is lubiprostone (Amitiza), which is a chloride channel activator. The mechanism of action, efficacy, and adverse events associated with linaclotide appear to be different from those of lubiprostone, Dr. Rao said in an interview.

Diarrhea was the most common adverse event, occurring in 19.5% of linaclotide and 3.5% of placebo patients. Rates of other adverse events were similar with linaclotide and placebo, including abdominal pain (5.4% vs. 2.5%), headache (5% vs. 3.5%), and flatulence (5% vs. 1.5%).

Dr. Rao said that patients in clinical practice would need to remain on continuous linaclotide, but noted that a long-term study, also presented at DDW, included data for 6 months showing persistent improvement.

Ironwood Pharmaceuticals and Forest Laboratories sponsored the trial. Dr. Rao disclosed consulting and serving as an advisor or review panel member for Forest, Takeda Pharmaceuticals, and the Dannon Co. His coauthors reported financial relationships with Ironwood and Forest.

CHICAGO – The investigational agent linaclotide brought relief from the symptoms of irritable bowel syndrome with constipation in a randomized phase III trial of 800 patients.

Linaclotide significantly improved all 4 primary efficacy end points and all 10 secondary efficacy end points when it was compared with placebo in the 16-week trial, Dr. Satish S.C. Rao reported at the annual Digestive Disease Week.

The study sponsors (Ironwood Pharmaceuticals and Forest Laboratories) reported that they are on track to submit a New Drug Application later this year to the Food and Drug Administration for the indications of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. European partner Almirall S.A. is expected to file for the IBS-C indication in Europe in the second half of 2011. During the 2-week pretreatment baseline period, patients in the study met modified Rome II criteria for IBS-C, and had an average of fewer than three complete spontaneous bowel movements (CSBMs) per week, and five or fewer spontaneous bowel movements per week, plus abdominal pain rated as a 3 or higher on a 10-point severity scale. Most (91%) of the 800 patients were female, and 77% were white. During the pretreatment period, 88% of patients experienced abdominal pain every day.

Patients were randomized to linaclotide 266 mcg or placebo (405 and 395 patients, respectively) once daily for 12 weeks, followed by a 4-week randomized withdrawal period during which the linaclotide group either continued on treatment or switched to placebo, and placebo patients switched to active treatment.

In all, 19.5% of patients on linaclotide were able to have at least three CSBMs and at least one additional bowel movement per week for at least 9 of 12 weeks, compared with only 6.3% of patients on placebo (P less than .0001), reported Dr. Rao, professor and director of neurogastroenterology and motility at the University of Iowa in Iowa City.

For at least 9 of 12 weeks, 34.3% of linaclotide-treated patients experienced at least a 30% reduction in abdominal pain, as did 27.1% of controls, a significant difference (P less than .05).

Both of these end points were achieved for at least 9 of 12 weeks by 12% of the linaclotide patients and 5% of controls (P less than .001).

The fourth primary end point, created by the FDA last year to provide guidance for the industry, required at least a 30% reduction in abdominal pain and an increase of at least one CSBM per week, both for at least 6 of 12 weeks. In all, 33.6% of the linaclotide patients and 21% of controls achieved this end point (P less than .0001).

The linaclotide group experienced significant improvements, compared with the placebo group, on all secondary end points including bloating severity scores, abdominal discomfort severity scores, CSBMs per week, and straining scores, he said.

Patients who continued on or switched to linaclotide improved, whereas patients who switched from linaclotide to placebo showed a relapse of symptoms.

Linaclotide is a 14–amino acid investigational peptide that increases generation of cyclic guanosine monophosphate (cGMP) in patients with IBS. Based on preclinical data, cGMP is thought to increase luminal fluid secretion and also to enhance intestinal transit and reduce visceral pain by modulating the activity of afferent nerves, Dr. Rao explained.

The only other FDA-approved drug for this disorder is lubiprostone (Amitiza), which is a chloride channel activator. The mechanism of action, efficacy, and adverse events associated with linaclotide appear to be different from those of lubiprostone, Dr. Rao said in an interview.

Diarrhea was the most common adverse event, occurring in 19.5% of linaclotide and 3.5% of placebo patients. Rates of other adverse events were similar with linaclotide and placebo, including abdominal pain (5.4% vs. 2.5%), headache (5% vs. 3.5%), and flatulence (5% vs. 1.5%).

Dr. Rao said that patients in clinical practice would need to remain on continuous linaclotide, but noted that a long-term study, also presented at DDW, included data for 6 months showing persistent improvement.

Ironwood Pharmaceuticals and Forest Laboratories sponsored the trial. Dr. Rao disclosed consulting and serving as an advisor or review panel member for Forest, Takeda Pharmaceuticals, and the Dannon Co. His coauthors reported financial relationships with Ironwood and Forest.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Significantly more polyps were detected during colonoscopies when an anesthesiologist was present, compared with colonoscopies without an anesthesiologist, based on data from more than 4.5 million index colonoscopies. The findings were presented at the annual Digestive Disease Week.

Use of an anesthesiologist during colonoscopy has been associated with improved patient and provider satisfaction, but the diagnostic impact on polyp detection has not been well studied, said Dr. Brooks D. Cash of the National Naval Medical Center in Bethesda, Md.

The report "represents one of the first products of the new AGA [American Gastroenterological Association] Digestive Health Outcomes Registry," said Dr. Cash. "It has become increasingly important to have registries that look at quality and effectiveness of what we do as gastroenterologists," he said.

In this study, Dr. Cash and colleagues reviewed data from 4,539,547 index colonoscopies performed between 2001 and 2010. Based on coding data, approximately one-third of the colonoscopies involved an anesthesiologist.

Overall, the polyp detection rate was 37.7% for procedures with an anesthesiologist present, compared with 37% in procedures without an anesthesiologist. Because of the large numbers in the study, this difference was statistically significant (P less than .05).

In addition, significantly more individuals were diagnosed with colorectal cancer within 3 years of the index colonoscopy with an anesthesiologist present than without an anesthesiologist (1.97% vs. 1.71%).

Among men, the polyp detection rate was 43.18% with an anesthesiologist and 43.08% without an anesthesiologist. Among women, these rates were 33.17% and 31.95%, respectively. The differences were significant for both sexes.

The differences in colorectal cancer diagnosis after 3 years also remained significant by sex, the researchers noted. Among men, 2.12% of those who had an anesthesiologist present for their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.93% of those without an anesthesiologist present. Among women, 1.84% of those who had an anesthesiologist present at their colonoscopies were diagnosed with colorectal cancer within 3 years, compared with 1.54% of those without an anesthesiologist present.

The trends held constant for age as well as sex: Both polyp detection and colon cancer incidence after 3 years were slightly higher when an anesthesiologist was present for patients aged younger than 65 years and for those aged 65 years and older.

The study is important because there are significant costs – up to $700 per case – when an anesthesiologist is involved in a colonoscopy, although the cost varies by region, Dr. Cash said.

The use of anesthesiologists for colonoscopies began with comorbid patients who had a higher risk of moderate sedation complications, Dr. Cash said. "We have seen that the use of anesthesiologists has become more common, even for patients who are at average risk," he noted.

"What we are going to have to figure out as a society and as professional organizations is whether those additional costs merit the very slight increases in polyp detection rate," said Dr. Cash. "We also need to figure out why the colorectal cancer incidence 3 years after index colonoscopies with anesthesia providers is slightly higher," he said.

Dr. Cash had no financial conflicts to disclose.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.