AACE 2014

LAS VEGAS – Analysis of data from a company that provides therapy for low testosterone showed that the treatment was not associated with a higher risk of myocardial infarction and stroke in men, and it may have played a protective role.

The findings clash with what two recent studies – one published in JAMA and the other in PLoS One – found, which showed that testosterone therapy increased the risk of MI and stroke in men, prompting the Food and Drug Administration to reassess the safety of the approved treatments.

Dr. Aaron Vinik, Murray Waitzer Endowed Chair for Diabetes Research at Eastern Virginia Medical School, Norfolk, puts the studies in perspective in this interview, and shares how patients should be treated based on current data and available knowledge.

nmiller@frontlinemedcom.com On Twitter @naseemsmiller

LAS VEGAS – Analysis of data from a company that provides therapy for low testosterone showed that the treatment was not associated with a higher risk of myocardial infarction and stroke in men, and it may have played a protective role.

The findings clash with what two recent studies – one published in JAMA and the other in PLoS One – found, which showed that testosterone therapy increased the risk of MI and stroke in men, prompting the Food and Drug Administration to reassess the safety of the approved treatments.

Dr. Aaron Vinik, Murray Waitzer Endowed Chair for Diabetes Research at Eastern Virginia Medical School, Norfolk, puts the studies in perspective in this interview, and shares how patients should be treated based on current data and available knowledge.

nmiller@frontlinemedcom.com On Twitter @naseemsmiller

LAS VEGAS – Analysis of data from a company that provides therapy for low testosterone showed that the treatment was not associated with a higher risk of myocardial infarction and stroke in men, and it may have played a protective role.

The findings clash with what two recent studies – one published in JAMA and the other in PLoS One – found, which showed that testosterone therapy increased the risk of MI and stroke in men, prompting the Food and Drug Administration to reassess the safety of the approved treatments.

Dr. Aaron Vinik, Murray Waitzer Endowed Chair for Diabetes Research at Eastern Virginia Medical School, Norfolk, puts the studies in perspective in this interview, and shares how patients should be treated based on current data and available knowledge.

nmiller@frontlinemedcom.com On Twitter @naseemsmiller

LAS VEGAS – The antidiabetic drug liraglutide promotes weight loss in overweight and obese individuals who do not have diabetes, according to results from a randomized trial reported on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

The 3,731 patients enrolled in the SCALE (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities) trial were randomized 2:1 to treatment with once-daily subcutaneous 3.0 mg liraglutide or placebo, each along with caloric reduction and exercise. All patients were overweight or obese, with no known diabetes. About two-thirds had prediabetes.

At 56 weeks, patients given liraglutide had lost 8.0% of their body weight, compared with their counterparts given placebo, who had lost 2.6% (P less than .0001), reported lead author Dr. F. Xavier Pi-Sunyer, codirector of the New York Obesity Nutrition Research Center at St. Luke’s–Roosevelt Hospital Center, and professor of medicine at the Institute of Human Nutrition, Columbia University, in New York. The drug also had significant positive effects on various metabolic and lipid measures.

Rates of serious adverse events were similar with liraglutide and placebo, with the exception of pancreatitis and gallbladder disorders, which although still rare, were more than twice as common with the drug.

Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed as Victoza. The 3.0-mg formulation used in SCALE is investigational.* 

"Liraglutide 3.0 mg, as an adjunct to diet and exercise, was efficacious and generally well tolerated. It was associated with significant benefits in addition to weight loss, including improvement in hemoglobin A_1c, fasting plasma glucose, blood pressure, and fasting lipids," Dr. Pi-Sunyer commented.

"The imbalance on pancreatitis and gallbladder disorders is undergoing further investigation," he added. "With regard to acute pancreatitis, no consistent mode or latency period was found. The majority of the events were mild according to the revised Atlanta criteria and were quickly reversible with stopping of the drug."

Session attendee Dr. Daniel Hurley, an endocrinologist at the Mayo Clinic in Rochester, Minn., asked, "In the patients with pancreatitis, any clinical idea whether this was gallstone induced or triglyceride induced?"

"Actually, the group that had the best result with regard to triglycerides did have a little more pancreatitis, so I don’t think it’s a triglyceride effect; in other words, the drug did drop triglycerides in these patients," Dr. Pi-Sunyer replied. "Only one patient developed both gallstones and pancreatitis; I don’t believe the two are probably related. We know that with weight loss, you get more gallstones and cholecystitis, and the drug group obviously had much better weight loss than the control group. I think that probably explains the gallbladder effect."

Liraglutide and other long-acting glucagonlike peptide–1 (GLP-1) receptor agonists are well known to decrease appetite and produce satiety, session comoderator Dr. Edward S. Horton, professor of medicine at Harvard Medical School, Boston, noted in an interview.

"So there’s a lot of interest now in using that not just for improving glucose metabolism in the diabetic, but as a weight loss agent. In the diabetes field, it’s really a two-fer – you basically improve glucose metabolism and you get the weight loss. But this is one of the first trials specifically just treating obesity without diabetes, and I’m sure they want to get FDA [Food and Drug Administration] approval for it" for this indication, he said. "It’s coming; we’re going to be using the GLP-1 receptor agonists for obesity," he predicted.

The 3.0-mg dose used in the trial is higher than the dose of 1.8 mg or so typically used in patients with diabetes, Dr. Horton noted. "There has been all the controversy about pancreatitis and so forth, and what was important here was showing that the higher dose didn’t increase the risk for any of these rare complications. But you have to be aware of them, and anybody who’s had pancreatitis, that’s a contraindication of course. But I think the drugs are safe even at the higher dose."

In the trial, patients given liraglutide (manufactured by Novo Nordisk) had significant improvements from baseline in waist circumference (–4.2 cm), body mass index (–2.0 kg/m²), fasting plasma glucose level (–6.9 mg/dL), hemoglobin A_1c level (–0.2%), systolic and diastolic blood pressure (–2.8/–0.9 mm Hg), and fasting lipids.

The rate of serious adverse events was 6.2% with the drug and 5.0% with placebo. The respective rates of events leading to treatment discontinuation were 9.9% and 3.8%.

The leading adverse events were nausea, diarrhea, and constipation. Nausea most commonly appeared in the first 4 weeks of treatment and was generally mild or moderate.

"The safety profile was generally consistent with that of previous clinical trials with liraglutide 3.0 mg and liraglutide 1.8 mg in individuals with type 2 diabetes," Dr. Pi-Sunyer commented.

Patients in the liraglutide group had a higher rate of acute pancreatitis (0.3 vs. 0.1 events per 100 patient-years of exposure) and gallbladder disorders (2.7 vs. 1.0 events per 100 patient-years of exposure). A single patient in each treatment group had both conditions.

Dr. Pi-Sunyer disclosed that he is an adviser to Novo Nordisk, Weight Watchers, Johnson & Johnson, Vivus, Eisai, and Zafgen. Novo Nordisk sponsored the trial and supported preparation of the presentation.

*CORRECTION, 5/22/14: A previous version of this article stated that Victoza was used in the SCALE trial. The liraglutide 3.0-mg formulation used in SCALE is investigational.

LAS VEGAS – The antidiabetic drug liraglutide promotes weight loss in overweight and obese individuals who do not have diabetes, according to results from a randomized trial reported on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

The 3,731 patients enrolled in the SCALE (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities) trial were randomized 2:1 to treatment with once-daily subcutaneous 3.0 mg liraglutide or placebo, each along with caloric reduction and exercise. All patients were overweight or obese, with no known diabetes. About two-thirds had prediabetes.

At 56 weeks, patients given liraglutide had lost 8.0% of their body weight, compared with their counterparts given placebo, who had lost 2.6% (P less than .0001), reported lead author Dr. F. Xavier Pi-Sunyer, codirector of the New York Obesity Nutrition Research Center at St. Luke’s–Roosevelt Hospital Center, and professor of medicine at the Institute of Human Nutrition, Columbia University, in New York. The drug also had significant positive effects on various metabolic and lipid measures.

Rates of serious adverse events were similar with liraglutide and placebo, with the exception of pancreatitis and gallbladder disorders, which although still rare, were more than twice as common with the drug.

Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed as Victoza. The 3.0-mg formulation used in SCALE is investigational.* 

"Liraglutide 3.0 mg, as an adjunct to diet and exercise, was efficacious and generally well tolerated. It was associated with significant benefits in addition to weight loss, including improvement in hemoglobin A_1c, fasting plasma glucose, blood pressure, and fasting lipids," Dr. Pi-Sunyer commented.

"The imbalance on pancreatitis and gallbladder disorders is undergoing further investigation," he added. "With regard to acute pancreatitis, no consistent mode or latency period was found. The majority of the events were mild according to the revised Atlanta criteria and were quickly reversible with stopping of the drug."

Session attendee Dr. Daniel Hurley, an endocrinologist at the Mayo Clinic in Rochester, Minn., asked, "In the patients with pancreatitis, any clinical idea whether this was gallstone induced or triglyceride induced?"

"Actually, the group that had the best result with regard to triglycerides did have a little more pancreatitis, so I don’t think it’s a triglyceride effect; in other words, the drug did drop triglycerides in these patients," Dr. Pi-Sunyer replied. "Only one patient developed both gallstones and pancreatitis; I don’t believe the two are probably related. We know that with weight loss, you get more gallstones and cholecystitis, and the drug group obviously had much better weight loss than the control group. I think that probably explains the gallbladder effect."

Liraglutide and other long-acting glucagonlike peptide–1 (GLP-1) receptor agonists are well known to decrease appetite and produce satiety, session comoderator Dr. Edward S. Horton, professor of medicine at Harvard Medical School, Boston, noted in an interview.

"So there’s a lot of interest now in using that not just for improving glucose metabolism in the diabetic, but as a weight loss agent. In the diabetes field, it’s really a two-fer – you basically improve glucose metabolism and you get the weight loss. But this is one of the first trials specifically just treating obesity without diabetes, and I’m sure they want to get FDA [Food and Drug Administration] approval for it" for this indication, he said. "It’s coming; we’re going to be using the GLP-1 receptor agonists for obesity," he predicted.

The 3.0-mg dose used in the trial is higher than the dose of 1.8 mg or so typically used in patients with diabetes, Dr. Horton noted. "There has been all the controversy about pancreatitis and so forth, and what was important here was showing that the higher dose didn’t increase the risk for any of these rare complications. But you have to be aware of them, and anybody who’s had pancreatitis, that’s a contraindication of course. But I think the drugs are safe even at the higher dose."

In the trial, patients given liraglutide (manufactured by Novo Nordisk) had significant improvements from baseline in waist circumference (–4.2 cm), body mass index (–2.0 kg/m²), fasting plasma glucose level (–6.9 mg/dL), hemoglobin A_1c level (–0.2%), systolic and diastolic blood pressure (–2.8/–0.9 mm Hg), and fasting lipids.

The rate of serious adverse events was 6.2% with the drug and 5.0% with placebo. The respective rates of events leading to treatment discontinuation were 9.9% and 3.8%.

The leading adverse events were nausea, diarrhea, and constipation. Nausea most commonly appeared in the first 4 weeks of treatment and was generally mild or moderate.

"The safety profile was generally consistent with that of previous clinical trials with liraglutide 3.0 mg and liraglutide 1.8 mg in individuals with type 2 diabetes," Dr. Pi-Sunyer commented.

Patients in the liraglutide group had a higher rate of acute pancreatitis (0.3 vs. 0.1 events per 100 patient-years of exposure) and gallbladder disorders (2.7 vs. 1.0 events per 100 patient-years of exposure). A single patient in each treatment group had both conditions.

Dr. Pi-Sunyer disclosed that he is an adviser to Novo Nordisk, Weight Watchers, Johnson & Johnson, Vivus, Eisai, and Zafgen. Novo Nordisk sponsored the trial and supported preparation of the presentation.

*CORRECTION, 5/22/14: A previous version of this article stated that Victoza was used in the SCALE trial. The liraglutide 3.0-mg formulation used in SCALE is investigational.

LAS VEGAS – The antidiabetic drug liraglutide promotes weight loss in overweight and obese individuals who do not have diabetes, according to results from a randomized trial reported on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

The 3,731 patients enrolled in the SCALE (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities) trial were randomized 2:1 to treatment with once-daily subcutaneous 3.0 mg liraglutide or placebo, each along with caloric reduction and exercise. All patients were overweight or obese, with no known diabetes. About two-thirds had prediabetes.

At 56 weeks, patients given liraglutide had lost 8.0% of their body weight, compared with their counterparts given placebo, who had lost 2.6% (P less than .0001), reported lead author Dr. F. Xavier Pi-Sunyer, codirector of the New York Obesity Nutrition Research Center at St. Luke’s–Roosevelt Hospital Center, and professor of medicine at the Institute of Human Nutrition, Columbia University, in New York. The drug also had significant positive effects on various metabolic and lipid measures.

Rates of serious adverse events were similar with liraglutide and placebo, with the exception of pancreatitis and gallbladder disorders, which although still rare, were more than twice as common with the drug.

Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed as Victoza. The 3.0-mg formulation used in SCALE is investigational.* 

"Liraglutide 3.0 mg, as an adjunct to diet and exercise, was efficacious and generally well tolerated. It was associated with significant benefits in addition to weight loss, including improvement in hemoglobin A_1c, fasting plasma glucose, blood pressure, and fasting lipids," Dr. Pi-Sunyer commented.

"The imbalance on pancreatitis and gallbladder disorders is undergoing further investigation," he added. "With regard to acute pancreatitis, no consistent mode or latency period was found. The majority of the events were mild according to the revised Atlanta criteria and were quickly reversible with stopping of the drug."

Session attendee Dr. Daniel Hurley, an endocrinologist at the Mayo Clinic in Rochester, Minn., asked, "In the patients with pancreatitis, any clinical idea whether this was gallstone induced or triglyceride induced?"

"Actually, the group that had the best result with regard to triglycerides did have a little more pancreatitis, so I don’t think it’s a triglyceride effect; in other words, the drug did drop triglycerides in these patients," Dr. Pi-Sunyer replied. "Only one patient developed both gallstones and pancreatitis; I don’t believe the two are probably related. We know that with weight loss, you get more gallstones and cholecystitis, and the drug group obviously had much better weight loss than the control group. I think that probably explains the gallbladder effect."

Liraglutide and other long-acting glucagonlike peptide–1 (GLP-1) receptor agonists are well known to decrease appetite and produce satiety, session comoderator Dr. Edward S. Horton, professor of medicine at Harvard Medical School, Boston, noted in an interview.

"So there’s a lot of interest now in using that not just for improving glucose metabolism in the diabetic, but as a weight loss agent. In the diabetes field, it’s really a two-fer – you basically improve glucose metabolism and you get the weight loss. But this is one of the first trials specifically just treating obesity without diabetes, and I’m sure they want to get FDA [Food and Drug Administration] approval for it" for this indication, he said. "It’s coming; we’re going to be using the GLP-1 receptor agonists for obesity," he predicted.

The 3.0-mg dose used in the trial is higher than the dose of 1.8 mg or so typically used in patients with diabetes, Dr. Horton noted. "There has been all the controversy about pancreatitis and so forth, and what was important here was showing that the higher dose didn’t increase the risk for any of these rare complications. But you have to be aware of them, and anybody who’s had pancreatitis, that’s a contraindication of course. But I think the drugs are safe even at the higher dose."

In the trial, patients given liraglutide (manufactured by Novo Nordisk) had significant improvements from baseline in waist circumference (–4.2 cm), body mass index (–2.0 kg/m²), fasting plasma glucose level (–6.9 mg/dL), hemoglobin A_1c level (–0.2%), systolic and diastolic blood pressure (–2.8/–0.9 mm Hg), and fasting lipids.

The rate of serious adverse events was 6.2% with the drug and 5.0% with placebo. The respective rates of events leading to treatment discontinuation were 9.9% and 3.8%.

The leading adverse events were nausea, diarrhea, and constipation. Nausea most commonly appeared in the first 4 weeks of treatment and was generally mild or moderate.

"The safety profile was generally consistent with that of previous clinical trials with liraglutide 3.0 mg and liraglutide 1.8 mg in individuals with type 2 diabetes," Dr. Pi-Sunyer commented.

Patients in the liraglutide group had a higher rate of acute pancreatitis (0.3 vs. 0.1 events per 100 patient-years of exposure) and gallbladder disorders (2.7 vs. 1.0 events per 100 patient-years of exposure). A single patient in each treatment group had both conditions.

Dr. Pi-Sunyer disclosed that he is an adviser to Novo Nordisk, Weight Watchers, Johnson & Johnson, Vivus, Eisai, and Zafgen. Novo Nordisk sponsored the trial and supported preparation of the presentation.

*CORRECTION, 5/22/14: A previous version of this article stated that Victoza was used in the SCALE trial. The liraglutide 3.0-mg formulation used in SCALE is investigational.

LAS VEGAS – Testosterone improves insulin sensitivity and insulin signaling in diabetic men who are deficient in this hormone, finds a randomized trial reported at the annual meeting of the American Association of Clinical Endocrinologists.

Investigators led by Dr. Manav Batra of the University at Buffalo, State University of New York, assigned 41 men with hypogonadotropic hypogonadism evenly to receive intramuscular testosterone (250 mg) or placebo every 2 weeks for 24 weeks. The testosterone dose was adjusted to achieve free testosterone levels in the mid-normal range for healthy young men.

Main results of the trial showed that men in the testosterone group had a statistically significant 32% improvement in insulin sensitivity from baseline, but their counterparts in the placebo group had essentially no change in this measure.

Testosterone treatment also was associated with increased expression in adipose tissue of genes that mediate insulin signaling and decreased expression in mononuclear cells of genes that mediate insulin resistance. Placebo treatment was not associated with any changes.

The findings are important, as roughly one-third of men with type 2 diabetes have hypogonadotropic hypogonadism and testosterone deficiency is linked to unfavorable metabolic, lipid, and anthropometric changes that may increase cardiovascular risk, according to Dr. Batra.

"Testosterone replacement reverses these changes, and there is decline in fat mass, increase in lean mass, decline in inflammatory markers, and improved insulin signaling and hence insulin sensitivity, which may potentially reduce cardiovascular risk," he said in an interview.

"As these changes may have a bearing on future cardiovascular outcomes in people with hypogonadotropic hypogonadism in type 2 diabetes, the results of this study will lay the foundations for future longer-term studies investigating the effects of testosterone replacement on atherosclerosis and cardiovascular disease in hypogonadal type 2 diabetic and obese subjects," he added.

The study is consistent with earlier research linking both low and high testosterone levels with insulin resistance, Dr. Edward S. Horton, comoderator of the session in which the data were reported, said in an interview.

"The idea that testosterone deficiency is associated with insulin resistance has been around for 30 years. I look at this study as basically showing by modern methods that some of these old ideas are really holding up – that that’s true," he said.

"The data are very interesting and good data showing that, for people who are hypogonadal, we should be treating them to improve insulin sensitivity and getting the beneficial effects of testosterone beyond just the androgenic effects," maintained Dr. Horton, director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston.

In the study, the investigators first compared the 41 hypogonadal diabetic men participating in the trial with 50 eugonadal diabetic men, showing that the former did indeed have a host of adverse cardiometabolic measures when compared with the latter.

Among other favorable changes seen with testosterone treatment, men in that group had improvements from baseline in levels of insulin, homeostatic model assessment of insulin resistance (HOMA-IR), leptin, and C-reactive protein, Dr. Batra reported. Meanwhile, these measures remained unchanged in the placebo group.

Testosterone therapy was not associated with any significant improvements in levels of glucose or glycated hemoglobin, or in lipid profiles.

Dr. Batra disclosed no relevant conflicts of interest.

LAS VEGAS – Testosterone improves insulin sensitivity and insulin signaling in diabetic men who are deficient in this hormone, finds a randomized trial reported at the annual meeting of the American Association of Clinical Endocrinologists.

Investigators led by Dr. Manav Batra of the University at Buffalo, State University of New York, assigned 41 men with hypogonadotropic hypogonadism evenly to receive intramuscular testosterone (250 mg) or placebo every 2 weeks for 24 weeks. The testosterone dose was adjusted to achieve free testosterone levels in the mid-normal range for healthy young men.

Main results of the trial showed that men in the testosterone group had a statistically significant 32% improvement in insulin sensitivity from baseline, but their counterparts in the placebo group had essentially no change in this measure.

Testosterone treatment also was associated with increased expression in adipose tissue of genes that mediate insulin signaling and decreased expression in mononuclear cells of genes that mediate insulin resistance. Placebo treatment was not associated with any changes.

The findings are important, as roughly one-third of men with type 2 diabetes have hypogonadotropic hypogonadism and testosterone deficiency is linked to unfavorable metabolic, lipid, and anthropometric changes that may increase cardiovascular risk, according to Dr. Batra.

"Testosterone replacement reverses these changes, and there is decline in fat mass, increase in lean mass, decline in inflammatory markers, and improved insulin signaling and hence insulin sensitivity, which may potentially reduce cardiovascular risk," he said in an interview.

"As these changes may have a bearing on future cardiovascular outcomes in people with hypogonadotropic hypogonadism in type 2 diabetes, the results of this study will lay the foundations for future longer-term studies investigating the effects of testosterone replacement on atherosclerosis and cardiovascular disease in hypogonadal type 2 diabetic and obese subjects," he added.

The study is consistent with earlier research linking both low and high testosterone levels with insulin resistance, Dr. Edward S. Horton, comoderator of the session in which the data were reported, said in an interview.

"The idea that testosterone deficiency is associated with insulin resistance has been around for 30 years. I look at this study as basically showing by modern methods that some of these old ideas are really holding up – that that’s true," he said.

"The data are very interesting and good data showing that, for people who are hypogonadal, we should be treating them to improve insulin sensitivity and getting the beneficial effects of testosterone beyond just the androgenic effects," maintained Dr. Horton, director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston.

In the study, the investigators first compared the 41 hypogonadal diabetic men participating in the trial with 50 eugonadal diabetic men, showing that the former did indeed have a host of adverse cardiometabolic measures when compared with the latter.

Among other favorable changes seen with testosterone treatment, men in that group had improvements from baseline in levels of insulin, homeostatic model assessment of insulin resistance (HOMA-IR), leptin, and C-reactive protein, Dr. Batra reported. Meanwhile, these measures remained unchanged in the placebo group.

Testosterone therapy was not associated with any significant improvements in levels of glucose or glycated hemoglobin, or in lipid profiles.

Dr. Batra disclosed no relevant conflicts of interest.

LAS VEGAS – Testosterone improves insulin sensitivity and insulin signaling in diabetic men who are deficient in this hormone, finds a randomized trial reported at the annual meeting of the American Association of Clinical Endocrinologists.

Investigators led by Dr. Manav Batra of the University at Buffalo, State University of New York, assigned 41 men with hypogonadotropic hypogonadism evenly to receive intramuscular testosterone (250 mg) or placebo every 2 weeks for 24 weeks. The testosterone dose was adjusted to achieve free testosterone levels in the mid-normal range for healthy young men.

Main results of the trial showed that men in the testosterone group had a statistically significant 32% improvement in insulin sensitivity from baseline, but their counterparts in the placebo group had essentially no change in this measure.

Testosterone treatment also was associated with increased expression in adipose tissue of genes that mediate insulin signaling and decreased expression in mononuclear cells of genes that mediate insulin resistance. Placebo treatment was not associated with any changes.

The findings are important, as roughly one-third of men with type 2 diabetes have hypogonadotropic hypogonadism and testosterone deficiency is linked to unfavorable metabolic, lipid, and anthropometric changes that may increase cardiovascular risk, according to Dr. Batra.

"Testosterone replacement reverses these changes, and there is decline in fat mass, increase in lean mass, decline in inflammatory markers, and improved insulin signaling and hence insulin sensitivity, which may potentially reduce cardiovascular risk," he said in an interview.

"As these changes may have a bearing on future cardiovascular outcomes in people with hypogonadotropic hypogonadism in type 2 diabetes, the results of this study will lay the foundations for future longer-term studies investigating the effects of testosterone replacement on atherosclerosis and cardiovascular disease in hypogonadal type 2 diabetic and obese subjects," he added.

The study is consistent with earlier research linking both low and high testosterone levels with insulin resistance, Dr. Edward S. Horton, comoderator of the session in which the data were reported, said in an interview.

"The idea that testosterone deficiency is associated with insulin resistance has been around for 30 years. I look at this study as basically showing by modern methods that some of these old ideas are really holding up – that that’s true," he said.

"The data are very interesting and good data showing that, for people who are hypogonadal, we should be treating them to improve insulin sensitivity and getting the beneficial effects of testosterone beyond just the androgenic effects," maintained Dr. Horton, director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston.

In the study, the investigators first compared the 41 hypogonadal diabetic men participating in the trial with 50 eugonadal diabetic men, showing that the former did indeed have a host of adverse cardiometabolic measures when compared with the latter.

Among other favorable changes seen with testosterone treatment, men in that group had improvements from baseline in levels of insulin, homeostatic model assessment of insulin resistance (HOMA-IR), leptin, and C-reactive protein, Dr. Batra reported. Meanwhile, these measures remained unchanged in the placebo group.

Testosterone therapy was not associated with any significant improvements in levels of glucose or glycated hemoglobin, or in lipid profiles.

Dr. Batra disclosed no relevant conflicts of interest.

LAS VEGAS – Evolocumab, an investigational antibody that inhibits PCSK9, reduces levels of low-density lipoprotein cholesterol in hypercholesterolemic patients who have dysglycemia or metabolic syndrome – without worsening glucose metabolism, in contrast to what has been seen with high-intensity statin therapy, a new analysis shows.

"LDL-C reduction is an important intervention for patients with dysglycemia or metabolic syndrome. This analysis suggests evolocumab can safely reduce LDL-C in these patients and could become a valuable tool in their care," lead investigator Dr. Robert R. Henry said in an interview prior to presenting the results at the annual meeting of the American Association of Clinical Endocrinologists.

"PCSK9 inhibitors are evolving as a novel and exciting class of medications that significantly reduce LDL-C. Patients with conditions like diabetes may greatly benefit from these treatments, particularly many of them [who] are unable to achieve their LDL targets or have difficulty with statin-associated side effects," he added.

But before this new class of drugs becomes available to clinicians, "I think there are still lots of studies to be done with evolocumab," said Dr. Henry, who is with the division of endocrinology and metabolism at the University of California, San Diego.

"The efficacy is quite striking. Of course, it’s currently being evaluated in cardiovascular outcome trials whether evolocumab translates to reduced cardiovascular events. And there is a large study ongoing of about 22,500 high-risk cardiovascular patients who are being studied for cardiovascular outcomes. So in the future, assuming these studies are positive, there is, I guess, a good chance this will be available."

In an interview, session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston, commented, "That’s very impressive data, a 50% reduction in LDL cholesterol with this drug. I think those data are very exciting. The drug has to go through the whole development process, but if it holds up in longer, more detailed studies, I think it looks very promising."

"Right now, the other options are basically statins," Dr. Horton noted. "Statins are very, very effective, but a lot of people get side effects from the statins, particularly the myositis can be a major problem. So this may be a very good alternative for the people who don’t tolerate statins. The fact that it’s an injection once a month I think is not a big deal, rather than just an oral agent. Statins are easy to take – you just take your statin orally, but a lot of people have trouble with the statins. So I think it’s going to have a role."

The patients studied were participants in the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER), an extension trial in which patients from four phase II studies of evolocumab were randomized 2:1 to open-label monthly subcutaneous evolocumab plus standard of care or to standard of care alone for 1 year.

Results for the entire trial population, reported previously, showed that evolocumab was safe, well tolerated, and efficacious (Circulation 2014;129:234-43).

The new analysis, which additionally looked at impact on glucose metabolism in the subset with metabolic perturbations, was based on 109 patients with type 2 diabetes, 134 with impaired fasting glucose, and 425 with metabolic syndrome, some of whom had more than one condition.

Evolocumab was associated with an LDL-C reduction of 47% in patients with type 2 diabetes, 51% in those with impaired fasting glucose, and 52% in those with metabolic syndrome – this compared with no change in their counterparts given standard of care alone. (It was 53% with evolocumab in trial patients who did not have any of metabolic perturbations.)

"Reductions were comparable to those observed in OSLER patients without these conditions," pointed out Dr. Henry.

The drug was also associated with improvement relative to standard care in levels of HDL cholesterol, triglycerides, and lipoprotein(a) that were again similar to those seen in trial patients who did not have these conditions.

Importantly, evolocumab was not associated with any significant changes in fasting plasma glucose or glycated hemoglobin levels relative to standard of care.

The combined evolocumab group and standard of care group had essentially the same rates of adverse events (78% and 72%) and serious adverse events (8% and 6%). Rates of serious laboratory abnormalities such as marked elevation of creatine kinase were low and similar as well.

The trial was sponsored by Amgen. Dr. Henry disclosed that he has affiliations with Amgen and Sanofi.

LAS VEGAS – Evolocumab, an investigational antibody that inhibits PCSK9, reduces levels of low-density lipoprotein cholesterol in hypercholesterolemic patients who have dysglycemia or metabolic syndrome – without worsening glucose metabolism, in contrast to what has been seen with high-intensity statin therapy, a new analysis shows.

"LDL-C reduction is an important intervention for patients with dysglycemia or metabolic syndrome. This analysis suggests evolocumab can safely reduce LDL-C in these patients and could become a valuable tool in their care," lead investigator Dr. Robert R. Henry said in an interview prior to presenting the results at the annual meeting of the American Association of Clinical Endocrinologists.

"PCSK9 inhibitors are evolving as a novel and exciting class of medications that significantly reduce LDL-C. Patients with conditions like diabetes may greatly benefit from these treatments, particularly many of them [who] are unable to achieve their LDL targets or have difficulty with statin-associated side effects," he added.

But before this new class of drugs becomes available to clinicians, "I think there are still lots of studies to be done with evolocumab," said Dr. Henry, who is with the division of endocrinology and metabolism at the University of California, San Diego.

"The efficacy is quite striking. Of course, it’s currently being evaluated in cardiovascular outcome trials whether evolocumab translates to reduced cardiovascular events. And there is a large study ongoing of about 22,500 high-risk cardiovascular patients who are being studied for cardiovascular outcomes. So in the future, assuming these studies are positive, there is, I guess, a good chance this will be available."

In an interview, session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston, commented, "That’s very impressive data, a 50% reduction in LDL cholesterol with this drug. I think those data are very exciting. The drug has to go through the whole development process, but if it holds up in longer, more detailed studies, I think it looks very promising."

"Right now, the other options are basically statins," Dr. Horton noted. "Statins are very, very effective, but a lot of people get side effects from the statins, particularly the myositis can be a major problem. So this may be a very good alternative for the people who don’t tolerate statins. The fact that it’s an injection once a month I think is not a big deal, rather than just an oral agent. Statins are easy to take – you just take your statin orally, but a lot of people have trouble with the statins. So I think it’s going to have a role."

The patients studied were participants in the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER), an extension trial in which patients from four phase II studies of evolocumab were randomized 2:1 to open-label monthly subcutaneous evolocumab plus standard of care or to standard of care alone for 1 year.

Results for the entire trial population, reported previously, showed that evolocumab was safe, well tolerated, and efficacious (Circulation 2014;129:234-43).

The new analysis, which additionally looked at impact on glucose metabolism in the subset with metabolic perturbations, was based on 109 patients with type 2 diabetes, 134 with impaired fasting glucose, and 425 with metabolic syndrome, some of whom had more than one condition.

Evolocumab was associated with an LDL-C reduction of 47% in patients with type 2 diabetes, 51% in those with impaired fasting glucose, and 52% in those with metabolic syndrome – this compared with no change in their counterparts given standard of care alone. (It was 53% with evolocumab in trial patients who did not have any of metabolic perturbations.)

"Reductions were comparable to those observed in OSLER patients without these conditions," pointed out Dr. Henry.

The drug was also associated with improvement relative to standard care in levels of HDL cholesterol, triglycerides, and lipoprotein(a) that were again similar to those seen in trial patients who did not have these conditions.

Importantly, evolocumab was not associated with any significant changes in fasting plasma glucose or glycated hemoglobin levels relative to standard of care.

The combined evolocumab group and standard of care group had essentially the same rates of adverse events (78% and 72%) and serious adverse events (8% and 6%). Rates of serious laboratory abnormalities such as marked elevation of creatine kinase were low and similar as well.

The trial was sponsored by Amgen. Dr. Henry disclosed that he has affiliations with Amgen and Sanofi.

LAS VEGAS – Evolocumab, an investigational antibody that inhibits PCSK9, reduces levels of low-density lipoprotein cholesterol in hypercholesterolemic patients who have dysglycemia or metabolic syndrome – without worsening glucose metabolism, in contrast to what has been seen with high-intensity statin therapy, a new analysis shows.

"LDL-C reduction is an important intervention for patients with dysglycemia or metabolic syndrome. This analysis suggests evolocumab can safely reduce LDL-C in these patients and could become a valuable tool in their care," lead investigator Dr. Robert R. Henry said in an interview prior to presenting the results at the annual meeting of the American Association of Clinical Endocrinologists.

"PCSK9 inhibitors are evolving as a novel and exciting class of medications that significantly reduce LDL-C. Patients with conditions like diabetes may greatly benefit from these treatments, particularly many of them [who] are unable to achieve their LDL targets or have difficulty with statin-associated side effects," he added.

But before this new class of drugs becomes available to clinicians, "I think there are still lots of studies to be done with evolocumab," said Dr. Henry, who is with the division of endocrinology and metabolism at the University of California, San Diego.

"The efficacy is quite striking. Of course, it’s currently being evaluated in cardiovascular outcome trials whether evolocumab translates to reduced cardiovascular events. And there is a large study ongoing of about 22,500 high-risk cardiovascular patients who are being studied for cardiovascular outcomes. So in the future, assuming these studies are positive, there is, I guess, a good chance this will be available."

In an interview, session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston, commented, "That’s very impressive data, a 50% reduction in LDL cholesterol with this drug. I think those data are very exciting. The drug has to go through the whole development process, but if it holds up in longer, more detailed studies, I think it looks very promising."

"Right now, the other options are basically statins," Dr. Horton noted. "Statins are very, very effective, but a lot of people get side effects from the statins, particularly the myositis can be a major problem. So this may be a very good alternative for the people who don’t tolerate statins. The fact that it’s an injection once a month I think is not a big deal, rather than just an oral agent. Statins are easy to take – you just take your statin orally, but a lot of people have trouble with the statins. So I think it’s going to have a role."

The patients studied were participants in the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER), an extension trial in which patients from four phase II studies of evolocumab were randomized 2:1 to open-label monthly subcutaneous evolocumab plus standard of care or to standard of care alone for 1 year.

Results for the entire trial population, reported previously, showed that evolocumab was safe, well tolerated, and efficacious (Circulation 2014;129:234-43).

The new analysis, which additionally looked at impact on glucose metabolism in the subset with metabolic perturbations, was based on 109 patients with type 2 diabetes, 134 with impaired fasting glucose, and 425 with metabolic syndrome, some of whom had more than one condition.

Evolocumab was associated with an LDL-C reduction of 47% in patients with type 2 diabetes, 51% in those with impaired fasting glucose, and 52% in those with metabolic syndrome – this compared with no change in their counterparts given standard of care alone. (It was 53% with evolocumab in trial patients who did not have any of metabolic perturbations.)

"Reductions were comparable to those observed in OSLER patients without these conditions," pointed out Dr. Henry.

The drug was also associated with improvement relative to standard care in levels of HDL cholesterol, triglycerides, and lipoprotein(a) that were again similar to those seen in trial patients who did not have these conditions.

Importantly, evolocumab was not associated with any significant changes in fasting plasma glucose or glycated hemoglobin levels relative to standard of care.

The combined evolocumab group and standard of care group had essentially the same rates of adverse events (78% and 72%) and serious adverse events (8% and 6%). Rates of serious laboratory abnormalities such as marked elevation of creatine kinase were low and similar as well.

The trial was sponsored by Amgen. Dr. Henry disclosed that he has affiliations with Amgen and Sanofi.

LAS VEGAS – Evolocumab, an investigational antibody that inhibits PCSK9, reduces levels of low-density lipoprotein cholesterol in hypercholesterolemic patients who have dysglycemia or metabolic syndrome – without worsening glucose metabolism, in contrast to what has been seen with high-intensity statin therapy, a new analysis shows.

"LDL-C reduction is an important intervention for patients with dysglycemia or metabolic syndrome. This analysis suggests evolocumab can safely reduce LDL-C in these patients and could become a valuable tool in their care," lead investigator Dr. Robert R. Henry said in an interview prior to presenting the results at the annual meeting of the American Association of Clinical Endocrinologists.

"PCSK9 inhibitors are evolving as a novel and exciting class of medications that significantly reduce LDL-C. Patients with conditions like diabetes may greatly benefit from these treatments, particularly many of them [who] are unable to achieve their LDL targets or have difficulty with statin-associated side effects," he added.

But before this new class of drugs becomes available to clinicians, "I think there are still lots of studies to be done with evolocumab," said Dr. Henry, who is with the division of endocrinology and metabolism at the University of California, San Diego.

"The efficacy is quite striking. Of course, it’s currently being evaluated in cardiovascular outcome trials whether evolocumab translates to reduced cardiovascular events. And there is a large study ongoing of about 22,500 high-risk cardiovascular patients who are being studied for cardiovascular outcomes. So in the future, assuming these studies are positive, there is, I guess, a good chance this will be available."

In an interview, session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston, commented, "That’s very impressive data, a 50% reduction in LDL cholesterol with this drug. I think those data are very exciting. The drug has to go through the whole development process, but if it holds up in longer, more detailed studies, I think it looks very promising."

"Right now, the other options are basically statins," Dr. Horton noted. "Statins are very, very effective, but a lot of people get side effects from the statins, particularly the myositis can be a major problem. So this may be a very good alternative for the people who don’t tolerate statins. The fact that it’s an injection once a month I think is not a big deal, rather than just an oral agent. Statins are easy to take – you just take your statin orally, but a lot of people have trouble with the statins. So I think it’s going to have a role."

The patients studied were participants in the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER), an extension trial in which patients from four phase II studies of evolocumab were randomized 2:1 to open-label monthly subcutaneous evolocumab plus standard of care or to standard of care alone for 1 year.

Results for the entire trial population, reported previously, showed that evolocumab was safe, well tolerated, and efficacious (Circulation 2014;129:234-43).

The new analysis, which additionally looked at impact on glucose metabolism in the subset with metabolic perturbations, was based on 109 patients with type 2 diabetes, 134 with impaired fasting glucose, and 425 with metabolic syndrome, some of whom had more than one condition.

Evolocumab was associated with an LDL-C reduction of 47% in patients with type 2 diabetes, 51% in those with impaired fasting glucose, and 52% in those with metabolic syndrome – this compared with no change in their counterparts given standard of care alone. (It was 53% with evolocumab in trial patients who did not have any of metabolic perturbations.)

"Reductions were comparable to those observed in OSLER patients without these conditions," pointed out Dr. Henry.

The drug was also associated with improvement relative to standard care in levels of HDL cholesterol, triglycerides, and lipoprotein(a) that were again similar to those seen in trial patients who did not have these conditions.

Importantly, evolocumab was not associated with any significant changes in fasting plasma glucose or glycated hemoglobin levels relative to standard of care.

The combined evolocumab group and standard of care group had essentially the same rates of adverse events (78% and 72%) and serious adverse events (8% and 6%). Rates of serious laboratory abnormalities such as marked elevation of creatine kinase were low and similar as well.

The trial was sponsored by Amgen. Dr. Henry disclosed that he has affiliations with Amgen and Sanofi.

LAS VEGAS – Evolocumab, an investigational antibody that inhibits PCSK9, reduces levels of low-density lipoprotein cholesterol in hypercholesterolemic patients who have dysglycemia or metabolic syndrome – without worsening glucose metabolism, in contrast to what has been seen with high-intensity statin therapy, a new analysis shows.

"LDL-C reduction is an important intervention for patients with dysglycemia or metabolic syndrome. This analysis suggests evolocumab can safely reduce LDL-C in these patients and could become a valuable tool in their care," lead investigator Dr. Robert R. Henry said in an interview prior to presenting the results at the annual meeting of the American Association of Clinical Endocrinologists.

"PCSK9 inhibitors are evolving as a novel and exciting class of medications that significantly reduce LDL-C. Patients with conditions like diabetes may greatly benefit from these treatments, particularly many of them [who] are unable to achieve their LDL targets or have difficulty with statin-associated side effects," he added.

But before this new class of drugs becomes available to clinicians, "I think there are still lots of studies to be done with evolocumab," said Dr. Henry, who is with the division of endocrinology and metabolism at the University of California, San Diego.

"The efficacy is quite striking. Of course, it’s currently being evaluated in cardiovascular outcome trials whether evolocumab translates to reduced cardiovascular events. And there is a large study ongoing of about 22,500 high-risk cardiovascular patients who are being studied for cardiovascular outcomes. So in the future, assuming these studies are positive, there is, I guess, a good chance this will be available."

In an interview, session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston, commented, "That’s very impressive data, a 50% reduction in LDL cholesterol with this drug. I think those data are very exciting. The drug has to go through the whole development process, but if it holds up in longer, more detailed studies, I think it looks very promising."

"Right now, the other options are basically statins," Dr. Horton noted. "Statins are very, very effective, but a lot of people get side effects from the statins, particularly the myositis can be a major problem. So this may be a very good alternative for the people who don’t tolerate statins. The fact that it’s an injection once a month I think is not a big deal, rather than just an oral agent. Statins are easy to take – you just take your statin orally, but a lot of people have trouble with the statins. So I think it’s going to have a role."

The patients studied were participants in the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER), an extension trial in which patients from four phase II studies of evolocumab were randomized 2:1 to open-label monthly subcutaneous evolocumab plus standard of care or to standard of care alone for 1 year.

Results for the entire trial population, reported previously, showed that evolocumab was safe, well tolerated, and efficacious (Circulation 2014;129:234-43).

The new analysis, which additionally looked at impact on glucose metabolism in the subset with metabolic perturbations, was based on 109 patients with type 2 diabetes, 134 with impaired fasting glucose, and 425 with metabolic syndrome, some of whom had more than one condition.

Evolocumab was associated with an LDL-C reduction of 47% in patients with type 2 diabetes, 51% in those with impaired fasting glucose, and 52% in those with metabolic syndrome – this compared with no change in their counterparts given standard of care alone. (It was 53% with evolocumab in trial patients who did not have any of metabolic perturbations.)

"Reductions were comparable to those observed in OSLER patients without these conditions," pointed out Dr. Henry.

The drug was also associated with improvement relative to standard care in levels of HDL cholesterol, triglycerides, and lipoprotein(a) that were again similar to those seen in trial patients who did not have these conditions.

Importantly, evolocumab was not associated with any significant changes in fasting plasma glucose or glycated hemoglobin levels relative to standard of care.

The combined evolocumab group and standard of care group had essentially the same rates of adverse events (78% and 72%) and serious adverse events (8% and 6%). Rates of serious laboratory abnormalities such as marked elevation of creatine kinase were low and similar as well.

The trial was sponsored by Amgen. Dr. Henry disclosed that he has affiliations with Amgen and Sanofi.

LAS VEGAS – Evolocumab, an investigational antibody that inhibits PCSK9, reduces levels of low-density lipoprotein cholesterol in hypercholesterolemic patients who have dysglycemia or metabolic syndrome – without worsening glucose metabolism, in contrast to what has been seen with high-intensity statin therapy, a new analysis shows.

"LDL-C reduction is an important intervention for patients with dysglycemia or metabolic syndrome. This analysis suggests evolocumab can safely reduce LDL-C in these patients and could become a valuable tool in their care," lead investigator Dr. Robert R. Henry said in an interview prior to presenting the results at the annual meeting of the American Association of Clinical Endocrinologists.

"PCSK9 inhibitors are evolving as a novel and exciting class of medications that significantly reduce LDL-C. Patients with conditions like diabetes may greatly benefit from these treatments, particularly many of them [who] are unable to achieve their LDL targets or have difficulty with statin-associated side effects," he added.

But before this new class of drugs becomes available to clinicians, "I think there are still lots of studies to be done with evolocumab," said Dr. Henry, who is with the division of endocrinology and metabolism at the University of California, San Diego.

"The efficacy is quite striking. Of course, it’s currently being evaluated in cardiovascular outcome trials whether evolocumab translates to reduced cardiovascular events. And there is a large study ongoing of about 22,500 high-risk cardiovascular patients who are being studied for cardiovascular outcomes. So in the future, assuming these studies are positive, there is, I guess, a good chance this will be available."

In an interview, session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, both in Boston, commented, "That’s very impressive data, a 50% reduction in LDL cholesterol with this drug. I think those data are very exciting. The drug has to go through the whole development process, but if it holds up in longer, more detailed studies, I think it looks very promising."

"Right now, the other options are basically statins," Dr. Horton noted. "Statins are very, very effective, but a lot of people get side effects from the statins, particularly the myositis can be a major problem. So this may be a very good alternative for the people who don’t tolerate statins. The fact that it’s an injection once a month I think is not a big deal, rather than just an oral agent. Statins are easy to take – you just take your statin orally, but a lot of people have trouble with the statins. So I think it’s going to have a role."

The patients studied were participants in the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER), an extension trial in which patients from four phase II studies of evolocumab were randomized 2:1 to open-label monthly subcutaneous evolocumab plus standard of care or to standard of care alone for 1 year.

Results for the entire trial population, reported previously, showed that evolocumab was safe, well tolerated, and efficacious (Circulation 2014;129:234-43).

The new analysis, which additionally looked at impact on glucose metabolism in the subset with metabolic perturbations, was based on 109 patients with type 2 diabetes, 134 with impaired fasting glucose, and 425 with metabolic syndrome, some of whom had more than one condition.

Evolocumab was associated with an LDL-C reduction of 47% in patients with type 2 diabetes, 51% in those with impaired fasting glucose, and 52% in those with metabolic syndrome – this compared with no change in their counterparts given standard of care alone. (It was 53% with evolocumab in trial patients who did not have any of metabolic perturbations.)

"Reductions were comparable to those observed in OSLER patients without these conditions," pointed out Dr. Henry.

The drug was also associated with improvement relative to standard care in levels of HDL cholesterol, triglycerides, and lipoprotein(a) that were again similar to those seen in trial patients who did not have these conditions.

Importantly, evolocumab was not associated with any significant changes in fasting plasma glucose or glycated hemoglobin levels relative to standard of care.

The combined evolocumab group and standard of care group had essentially the same rates of adverse events (78% and 72%) and serious adverse events (8% and 6%). Rates of serious laboratory abnormalities such as marked elevation of creatine kinase were low and similar as well.

The trial was sponsored by Amgen. Dr. Henry disclosed that he has affiliations with Amgen and Sanofi.

LAS VEGAS – Hispanic adults have high prevalences of diabetes and related disorders overall, the largest ongoing U.S. health study of this population showed, but there are noteworthy differences by sex and ancestry that argue against a one-size-fits-all approach to care for this population.

Participants in the Hispanic Community Health Study/Study of Latinos are 16,415 individuals aged 18-74 years from four cities (San Diego, Chicago, Miami, and New York) who self identified as Hispanic/Latino. Seventy-nine percent were foreign born.

Among key findings of the study’s 2008-2011 baseline examination, about 35% of participants had metabolic syndrome, 36% had prediabetes, and 17% had diabetes, lead investigator Dr. Larissa Avilés-Santa reported at the annual meeting of the American Association of Clinical Endocrinologists.

Subgroup analyses showed that women were more likely than men to have the abdominal obesity component of metabolic syndrome but less likely to have elevated triglycerides. And individuals of Cuban ancestry were the most likely to have high blood pressure.

There were similar variations for prediabetes (most common in participants of Mexican ancestry and least common in those of Dominican ancestry) and diabetes (most common in those of Dominican, Puerto Rican, and Mexican ancestry and least common in those of South American ancestry).

"One of the main messages is that Hispanics are not a monolith. It has been assumed for a long time that Hispanics are a very homogenous group ... and that is not the case. Although we have cultural, historical, religious similarities, we also have differences," she commented in a press briefing. "Assuming homogeneity is not the way to address clinical care with Hispanics. It’s better to ask questions, to get to know the patient – where the patient is coming from – and then go from there."

The observed differences may stem from factors related to both country of origin and current living environment, proposed Dr. Avilés-Santa, who is a medical officer with the division of cardiovascular sciences of the National Heart, Lung, and Blood Institute in Bethesda, Md. Those factors could range from the more easily measured (genetics, diet, and language barriers) to the harder to pin down (health policy, discrimination, health-related beliefs, and religion).

"All of that, taken into consideration, is important because all of it may be playing a big role in the differences that we are observing among Hispanic groups," she maintained.

Additional study data showed the age-adjusted prevalence of hypertension was about 25% among participants overall (Am. J. Hypertens. 2014;27:793-800). It was lowest for those of Mexican and South American ancestry and highest for those of Puerto Rican and Dominican ancestry.

The proportion of participants aged 18-64 years who lacked health insurance ranged from 29% in New York to 71% in Miami. Among older participants, it ranged from 4% in New York to 26% in San Diego. "This is ... a question about policy because the majority who are insured are insured through Medicare. So what is happening with the Hispanic elders? And what is happening with their health if they are not having appropriate insurance coverage?" Dr. Avilés-Santa asked.

The data raise the question as to whether current screening practices for the general population are appropriate for Hispanics, she said. Also, they suggest there are as yet unidentified risk and protective factors at work when it comes to the development of diabetes.

In the study’s longitudinal component, the investigators are following the participants by telephone annually and will reexamine them later this year. Follow-up will continue through at least 2019.

In addition to disseminating the findings to the various communities, the investigators have collected DNA samples and are exploring associations of genetic variants with health measures and outcomes through the Omics in Latinos (OLa) project.

Dr. Avilés-Santa had no relevant conflicts of interest.

LAS VEGAS – Hispanic adults have high prevalences of diabetes and related disorders overall, the largest ongoing U.S. health study of this population showed, but there are noteworthy differences by sex and ancestry that argue against a one-size-fits-all approach to care for this population.

Participants in the Hispanic Community Health Study/Study of Latinos are 16,415 individuals aged 18-74 years from four cities (San Diego, Chicago, Miami, and New York) who self identified as Hispanic/Latino. Seventy-nine percent were foreign born.

Among key findings of the study’s 2008-2011 baseline examination, about 35% of participants had metabolic syndrome, 36% had prediabetes, and 17% had diabetes, lead investigator Dr. Larissa Avilés-Santa reported at the annual meeting of the American Association of Clinical Endocrinologists.

Subgroup analyses showed that women were more likely than men to have the abdominal obesity component of metabolic syndrome but less likely to have elevated triglycerides. And individuals of Cuban ancestry were the most likely to have high blood pressure.

There were similar variations for prediabetes (most common in participants of Mexican ancestry and least common in those of Dominican ancestry) and diabetes (most common in those of Dominican, Puerto Rican, and Mexican ancestry and least common in those of South American ancestry).

"One of the main messages is that Hispanics are not a monolith. It has been assumed for a long time that Hispanics are a very homogenous group ... and that is not the case. Although we have cultural, historical, religious similarities, we also have differences," she commented in a press briefing. "Assuming homogeneity is not the way to address clinical care with Hispanics. It’s better to ask questions, to get to know the patient – where the patient is coming from – and then go from there."

The observed differences may stem from factors related to both country of origin and current living environment, proposed Dr. Avilés-Santa, who is a medical officer with the division of cardiovascular sciences of the National Heart, Lung, and Blood Institute in Bethesda, Md. Those factors could range from the more easily measured (genetics, diet, and language barriers) to the harder to pin down (health policy, discrimination, health-related beliefs, and religion).

"All of that, taken into consideration, is important because all of it may be playing a big role in the differences that we are observing among Hispanic groups," she maintained.

Additional study data showed the age-adjusted prevalence of hypertension was about 25% among participants overall (Am. J. Hypertens. 2014;27:793-800). It was lowest for those of Mexican and South American ancestry and highest for those of Puerto Rican and Dominican ancestry.

The proportion of participants aged 18-64 years who lacked health insurance ranged from 29% in New York to 71% in Miami. Among older participants, it ranged from 4% in New York to 26% in San Diego. "This is ... a question about policy because the majority who are insured are insured through Medicare. So what is happening with the Hispanic elders? And what is happening with their health if they are not having appropriate insurance coverage?" Dr. Avilés-Santa asked.

The data raise the question as to whether current screening practices for the general population are appropriate for Hispanics, she said. Also, they suggest there are as yet unidentified risk and protective factors at work when it comes to the development of diabetes.

In the study’s longitudinal component, the investigators are following the participants by telephone annually and will reexamine them later this year. Follow-up will continue through at least 2019.

In addition to disseminating the findings to the various communities, the investigators have collected DNA samples and are exploring associations of genetic variants with health measures and outcomes through the Omics in Latinos (OLa) project.

Dr. Avilés-Santa had no relevant conflicts of interest.

LAS VEGAS – Hispanic adults have high prevalences of diabetes and related disorders overall, the largest ongoing U.S. health study of this population showed, but there are noteworthy differences by sex and ancestry that argue against a one-size-fits-all approach to care for this population.

Participants in the Hispanic Community Health Study/Study of Latinos are 16,415 individuals aged 18-74 years from four cities (San Diego, Chicago, Miami, and New York) who self identified as Hispanic/Latino. Seventy-nine percent were foreign born.

Among key findings of the study’s 2008-2011 baseline examination, about 35% of participants had metabolic syndrome, 36% had prediabetes, and 17% had diabetes, lead investigator Dr. Larissa Avilés-Santa reported at the annual meeting of the American Association of Clinical Endocrinologists.

Subgroup analyses showed that women were more likely than men to have the abdominal obesity component of metabolic syndrome but less likely to have elevated triglycerides. And individuals of Cuban ancestry were the most likely to have high blood pressure.

There were similar variations for prediabetes (most common in participants of Mexican ancestry and least common in those of Dominican ancestry) and diabetes (most common in those of Dominican, Puerto Rican, and Mexican ancestry and least common in those of South American ancestry).

"One of the main messages is that Hispanics are not a monolith. It has been assumed for a long time that Hispanics are a very homogenous group ... and that is not the case. Although we have cultural, historical, religious similarities, we also have differences," she commented in a press briefing. "Assuming homogeneity is not the way to address clinical care with Hispanics. It’s better to ask questions, to get to know the patient – where the patient is coming from – and then go from there."

The observed differences may stem from factors related to both country of origin and current living environment, proposed Dr. Avilés-Santa, who is a medical officer with the division of cardiovascular sciences of the National Heart, Lung, and Blood Institute in Bethesda, Md. Those factors could range from the more easily measured (genetics, diet, and language barriers) to the harder to pin down (health policy, discrimination, health-related beliefs, and religion).

"All of that, taken into consideration, is important because all of it may be playing a big role in the differences that we are observing among Hispanic groups," she maintained.

Additional study data showed the age-adjusted prevalence of hypertension was about 25% among participants overall (Am. J. Hypertens. 2014;27:793-800). It was lowest for those of Mexican and South American ancestry and highest for those of Puerto Rican and Dominican ancestry.

The proportion of participants aged 18-64 years who lacked health insurance ranged from 29% in New York to 71% in Miami. Among older participants, it ranged from 4% in New York to 26% in San Diego. "This is ... a question about policy because the majority who are insured are insured through Medicare. So what is happening with the Hispanic elders? And what is happening with their health if they are not having appropriate insurance coverage?" Dr. Avilés-Santa asked.

The data raise the question as to whether current screening practices for the general population are appropriate for Hispanics, she said. Also, they suggest there are as yet unidentified risk and protective factors at work when it comes to the development of diabetes.

In the study’s longitudinal component, the investigators are following the participants by telephone annually and will reexamine them later this year. Follow-up will continue through at least 2019.

In addition to disseminating the findings to the various communities, the investigators have collected DNA samples and are exploring associations of genetic variants with health measures and outcomes through the Omics in Latinos (OLa) project.

Dr. Avilés-Santa had no relevant conflicts of interest.

LAS VEGAS – When it comes to treating Hispanic patients, one size doesn’t fit all, according to results from the ongoing Hispanic Community Health Study/Study of Latinos.

In a video interview, Dr. Larissa Avilés-Santa, a medical officer at the National Heart, Lung, and Blood Institute in Bethesda, Md., talks about the study’s findings and provides advice to physicians at the annual meeting of the American Association of Clinical Endocrinologists.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS – When it comes to treating Hispanic patients, one size doesn’t fit all, according to results from the ongoing Hispanic Community Health Study/Study of Latinos.

In a video interview, Dr. Larissa Avilés-Santa, a medical officer at the National Heart, Lung, and Blood Institute in Bethesda, Md., talks about the study’s findings and provides advice to physicians at the annual meeting of the American Association of Clinical Endocrinologists.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS – When it comes to treating Hispanic patients, one size doesn’t fit all, according to results from the ongoing Hispanic Community Health Study/Study of Latinos.

In a video interview, Dr. Larissa Avilés-Santa, a medical officer at the National Heart, Lung, and Blood Institute in Bethesda, Md., talks about the study’s findings and provides advice to physicians at the annual meeting of the American Association of Clinical Endocrinologists.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS – In its fourth year, the Blood Sugar Basics program, which is the American College of Endocrinology and Merck’s diabetes education program, is turning its attention to hemoglobin A_1c, because many patients with diabetes fail to achieve an HbA_1c of 6.5% or less, the program’s leaders said.

This year’s campaign was unveiled at the annual meeting of the American Association of Clinical Endocrinologists.

With the goal of increasing the number of patients who achieve their HbA_1c goal, the program has established three missions for patients: Talk to your physician; set goals and commit to a plan; and revisit and reassess.

The program’s website (bloodsugarbasics.com), which has had a facelift, provides forms and easy-to-follow guidelines for patients. The association is also distributing printed information about the program to AACE members, and this year, it is reaching out to primary care physicians, because there simply aren’t enough endocrinologists, said Dr. Etie Moghissi, who has helped develop the program since its inception in 2010.

Blood Sugar Basics is among a handful of credible diabetes education programs online, including the National Diabetes Education Program.

In a video interview, Dr. Moghissi of the department of medicine at the University of California, Los Angeles, explains the program’s goals, and why physicians should consider it as an educational source for their patients.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

LAS VEGAS – In its fourth year, the Blood Sugar Basics program, which is the American College of Endocrinology and Merck’s diabetes education program, is turning its attention to hemoglobin A_1c, because many patients with diabetes fail to achieve an HbA_1c of 6.5% or less, the program’s leaders said.

This year’s campaign was unveiled at the annual meeting of the American Association of Clinical Endocrinologists.

With the goal of increasing the number of patients who achieve their HbA_1c goal, the program has established three missions for patients: Talk to your physician; set goals and commit to a plan; and revisit and reassess.

The program’s website (bloodsugarbasics.com), which has had a facelift, provides forms and easy-to-follow guidelines for patients. The association is also distributing printed information about the program to AACE members, and this year, it is reaching out to primary care physicians, because there simply aren’t enough endocrinologists, said Dr. Etie Moghissi, who has helped develop the program since its inception in 2010.

Blood Sugar Basics is among a handful of credible diabetes education programs online, including the National Diabetes Education Program.

In a video interview, Dr. Moghissi of the department of medicine at the University of California, Los Angeles, explains the program’s goals, and why physicians should consider it as an educational source for their patients.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

LAS VEGAS – In its fourth year, the Blood Sugar Basics program, which is the American College of Endocrinology and Merck’s diabetes education program, is turning its attention to hemoglobin A_1c, because many patients with diabetes fail to achieve an HbA_1c of 6.5% or less, the program’s leaders said.

This year’s campaign was unveiled at the annual meeting of the American Association of Clinical Endocrinologists.

With the goal of increasing the number of patients who achieve their HbA_1c goal, the program has established three missions for patients: Talk to your physician; set goals and commit to a plan; and revisit and reassess.

The program’s website (bloodsugarbasics.com), which has had a facelift, provides forms and easy-to-follow guidelines for patients. The association is also distributing printed information about the program to AACE members, and this year, it is reaching out to primary care physicians, because there simply aren’t enough endocrinologists, said Dr. Etie Moghissi, who has helped develop the program since its inception in 2010.

Blood Sugar Basics is among a handful of credible diabetes education programs online, including the National Diabetes Education Program.

In a video interview, Dr. Moghissi of the department of medicine at the University of California, Los Angeles, explains the program’s goals, and why physicians should consider it as an educational source for their patients.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Treatment with canagliflozin was associated with significant weight loss as well as improvements in glycemic control, when compared with placebo in a 26-week, phase III study of nearly 600 patients.

Dr. William Canovatchel of Janssen Pharmaceuticals, the manufacturer of canagliflozin, is presenting these results on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

In phase III clinical trials, canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, has been associated with significant weight loss in a variety of patients, he noted. In the phase III randomized, placebo-controlled study, 584 patients with type 2 diabetes who were inadequately treated with diet and exercise were randomized to placebo or canagliflozin (300 mg or 100 mg once a day). The mean age was 55 years, and the patients’ mean hemoglobin A_1c was 8%. Their mean body weight was 191 pounds (86.8 kg).

At 26 weeks, the mean reductions in HbA_1c from baseline (the primary endpoint) among patients on the 100-mg and 300-mg doses of canagliflozin were 0.77% and 1.03%, respectively, compared with an increase of 0.14% among those on placebo. Differences between the drug and placebo were statistically significant.

In addition, those on the 100-mg and 300-mg canagliflozin doses lost a mean of 5.5 pounds (2.5 kg), and 7.5 pounds (3.4 kg), respectively, compared with a mean of 1 pound (0.5 kg) among those on placebo.

Moreover, 71% of those on 100 mg and 84% of those on 300 mg had reductions in both weight and HbA_1c, compared with 28% of those on placebo, according to Dr. Canovatchel.

Genital mycotic infections, urinary tract infections, and those related to osmotic diuresis were among the adverse events associated with canagliflozin, which was generally well tolerated, he said. The drug was associated with a low rate of hypoglycemia.

Canagliflozin (Invokana) was the first SGLT2 inhibitor to be approved in the United States, in March 2013. These agents, taken orally, work by inhibiting SGLT2 that is expressed in the kidney, reducing renal glucose reabsorption, increasing urinary excretion of glucose, and reducing plasma glucose levels.

The study was published last year (Diabetes Obes. Metab. 2013;15:372-82).

Dr. Canovatchel is an employee of Janssen, the manufacturer of canagliflozin.

emechcatie@frontlinemedcom.com

Treatment with canagliflozin was associated with significant weight loss as well as improvements in glycemic control, when compared with placebo in a 26-week, phase III study of nearly 600 patients.

Dr. William Canovatchel of Janssen Pharmaceuticals, the manufacturer of canagliflozin, is presenting these results on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

In phase III clinical trials, canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, has been associated with significant weight loss in a variety of patients, he noted. In the phase III randomized, placebo-controlled study, 584 patients with type 2 diabetes who were inadequately treated with diet and exercise were randomized to placebo or canagliflozin (300 mg or 100 mg once a day). The mean age was 55 years, and the patients’ mean hemoglobin A_1c was 8%. Their mean body weight was 191 pounds (86.8 kg).

At 26 weeks, the mean reductions in HbA_1c from baseline (the primary endpoint) among patients on the 100-mg and 300-mg doses of canagliflozin were 0.77% and 1.03%, respectively, compared with an increase of 0.14% among those on placebo. Differences between the drug and placebo were statistically significant.

In addition, those on the 100-mg and 300-mg canagliflozin doses lost a mean of 5.5 pounds (2.5 kg), and 7.5 pounds (3.4 kg), respectively, compared with a mean of 1 pound (0.5 kg) among those on placebo.

Moreover, 71% of those on 100 mg and 84% of those on 300 mg had reductions in both weight and HbA_1c, compared with 28% of those on placebo, according to Dr. Canovatchel.

Genital mycotic infections, urinary tract infections, and those related to osmotic diuresis were among the adverse events associated with canagliflozin, which was generally well tolerated, he said. The drug was associated with a low rate of hypoglycemia.

Canagliflozin (Invokana) was the first SGLT2 inhibitor to be approved in the United States, in March 2013. These agents, taken orally, work by inhibiting SGLT2 that is expressed in the kidney, reducing renal glucose reabsorption, increasing urinary excretion of glucose, and reducing plasma glucose levels.

The study was published last year (Diabetes Obes. Metab. 2013;15:372-82).

Dr. Canovatchel is an employee of Janssen, the manufacturer of canagliflozin.

emechcatie@frontlinemedcom.com

Treatment with canagliflozin was associated with significant weight loss as well as improvements in glycemic control, when compared with placebo in a 26-week, phase III study of nearly 600 patients.

Dr. William Canovatchel of Janssen Pharmaceuticals, the manufacturer of canagliflozin, is presenting these results on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

In phase III clinical trials, canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, has been associated with significant weight loss in a variety of patients, he noted. In the phase III randomized, placebo-controlled study, 584 patients with type 2 diabetes who were inadequately treated with diet and exercise were randomized to placebo or canagliflozin (300 mg or 100 mg once a day). The mean age was 55 years, and the patients’ mean hemoglobin A_1c was 8%. Their mean body weight was 191 pounds (86.8 kg).

At 26 weeks, the mean reductions in HbA_1c from baseline (the primary endpoint) among patients on the 100-mg and 300-mg doses of canagliflozin were 0.77% and 1.03%, respectively, compared with an increase of 0.14% among those on placebo. Differences between the drug and placebo were statistically significant.

In addition, those on the 100-mg and 300-mg canagliflozin doses lost a mean of 5.5 pounds (2.5 kg), and 7.5 pounds (3.4 kg), respectively, compared with a mean of 1 pound (0.5 kg) among those on placebo.

Moreover, 71% of those on 100 mg and 84% of those on 300 mg had reductions in both weight and HbA_1c, compared with 28% of those on placebo, according to Dr. Canovatchel.

Genital mycotic infections, urinary tract infections, and those related to osmotic diuresis were among the adverse events associated with canagliflozin, which was generally well tolerated, he said. The drug was associated with a low rate of hypoglycemia.

Canagliflozin (Invokana) was the first SGLT2 inhibitor to be approved in the United States, in March 2013. These agents, taken orally, work by inhibiting SGLT2 that is expressed in the kidney, reducing renal glucose reabsorption, increasing urinary excretion of glucose, and reducing plasma glucose levels.

The study was published last year (Diabetes Obes. Metab. 2013;15:372-82).

Dr. Canovatchel is an employee of Janssen, the manufacturer of canagliflozin.

emechcatie@frontlinemedcom.com