Suicide attempts on the rise among young U.S. adults

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Suicide attempts continue to increase in the United States, particularly among young adults with lower education levels and greater economic challenges, according to an analysis published Sept. 13.

These conclusions are based on data gleaned from two studies – the 2004-2005 wave 2 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-II) and the 2012-2013 NESARC-III. Of the 69,341 people surveyed, 57.2% were women, and the mean age was 48.1 years.

A wrist is shown wrapped in adhesive bandages with the word "HELP" spelled out across them.
ArishaRay/Thinkstock
Overall, the percentage of adults more than 21 years old who attempted suicide during the study periods increased significantly, from 0.62% in 2004-2005 to 0.79% in 2012-2013 (adjusted risk difference, 0.17%; 95% confidence interval, 0.01%-0.33%; P = .04), reported Mark Olfson, MD, of the department of psychiatry at Columbia University, New York, and his coauthors (JAMA Psychiatry. 2017 Sep 13. doi: 10.1001/jamapsychiatry.2017.2582).

However, the demographic groups that had the most notable increases were young adults aged 21-34 (ARD, 0.48%; 95% CI, 0.09%-0.87%; P = .02) and those with no more than a high school education (ADR, 0.49%; 95% CI, 0.18%-0.80%; P less than .002).

Dr. Olfson and his coauthors also found an increase in suicide attempts among adults with certain psychiatric disorders. Specifically, the risk for suicide attempts was higher for adults with antisocial personality disorder; among that group, the risk increased from 0.07% (95% CI, –0.09% to 0.23%) in 2004-2005 to 2.16% (95% CI, 0.61%-3.71%) in 2012-2013. “Other high-risk groups included persons with ... schizotypal ... personality disorders and those with anxiety and depressive disorders,” according to Dr. Olfson and his coauthors. “These findings highlight an increasing prevalence of suicide attempts and underscore the prominent role of mental disorders ... in risks for suicide attempts at the population level.”

Almost two-thirds of the adults who had recent suicide attempts in both NESARC survey groups had borderline personality disorder, the investigators reported. However, a finding the coauthors called “encouraging” is that “although most of the adults in the 2012-2013 survey who had recent suicide attempts had borderline personality disorder, the risk of attempted suicide among adults with borderline personality disorder significantly decreased during the study period,” Dr. Olfson and his coauthors wrote. They speculated that this decrease could be tied to findings showing that 40.8% of U.S. psychiatry residency programs offer training in dialectical behavior therapy for borderline personality disorder (Acad Psychiatry. 2013 Jul 1:37[4]:287-8). Clinician training programs are needed to help frontline clinicians manage self-harm among patients with borderline personality disorder, the investigators said.

In addition to many other risk factors, the investigators emphasized the correlation between recent suicide attempts and prior suicide attempts. About one-half of adults who reported a recent attempt also reported a prior attempt (95% CI, 16.46-33.67). “Because 15% to 25% of adults who die by suicide have received treatment for a suicide attempt within the past year, a substantial proportion of suicide deaths” could be subject to prior intervention that could be associated with an attempt, they said.

The data were limited in that adults who are homeless or incarcerated or who have schizophrenia were not surveyed. In addition, the coauthors cited the retrospective nature of NESARC self-reports as a limitation. Given the nature of the study, no data were collected from individuals who died of suicide. “This lack may have led to an underestimation of suicide attempts in each survey,” they wrote.

The study was supported by grants from the National Institutes of Health and the New York State Psychiatric Institute. The surveys were funded in part by the NIH Intramural Research Program. The authors did not report any financial disclosures.

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The findings by Mark Olfson, MD, MPH, and his associates “strongly echo” the discussions of Anne Case, PhD, and Angus Deaton, PhD, that underscore “the mortality rate effect of lower education levels, fundamental economic and vocational challenges, and social dislocation occurring in many communities across the United States.” But the work of Dr. Case and Dr. Deaton emphasizes that the biggest impact on deaths, including those caused by suicides, occurred in the middle years.

Meanwhile, findings from the National Violent Death Reporting System on suicide attempts in middle life show that more than two-thirds of men and more than 80% of women report having a disorder related to substance use or mental health, but only 25% of those men and 44% of those women ever received treatment for such conditions. The characteristics of these people, as recorded by the NVDRS, “fit into the populations discerned” by Dr. Case and Dr. Deaton. “While there are suggestions that the surveys used by Olfson et al. may not have been tuned to pick up the ‘signal’ that was associated with the rise in fatal suicide attempts during the first 15 years of the new century, they provided a clear warning that the coming generation of people aging into the ‘middle years’ may see a further rise in suicide rates.”

The National Epidemiologic Survey on Alcohol and Related Conditions surveys were not conducted in clinical settings. Therefore, clinicians need to “look beyond the walls” of their health facilities to engage potentially vulnerable individuals and their families before they become suicidal.

Eric D. Caine, MD, is the chair of the department of psychiatry and codirector of the Center for Study and Prevention of Suicide at the University of Rochester (N.Y.). These remarks have been adapted from an editorial accompanying the article by Dr. Olfson and his associates (JAMA Psychiatry. 2017 Sep 13. doi: 10.1001/jamapsychiatry.2017.2524 ). He reported no financial disclosures.

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The findings by Mark Olfson, MD, MPH, and his associates “strongly echo” the discussions of Anne Case, PhD, and Angus Deaton, PhD, that underscore “the mortality rate effect of lower education levels, fundamental economic and vocational challenges, and social dislocation occurring in many communities across the United States.” But the work of Dr. Case and Dr. Deaton emphasizes that the biggest impact on deaths, including those caused by suicides, occurred in the middle years.

Meanwhile, findings from the National Violent Death Reporting System on suicide attempts in middle life show that more than two-thirds of men and more than 80% of women report having a disorder related to substance use or mental health, but only 25% of those men and 44% of those women ever received treatment for such conditions. The characteristics of these people, as recorded by the NVDRS, “fit into the populations discerned” by Dr. Case and Dr. Deaton. “While there are suggestions that the surveys used by Olfson et al. may not have been tuned to pick up the ‘signal’ that was associated with the rise in fatal suicide attempts during the first 15 years of the new century, they provided a clear warning that the coming generation of people aging into the ‘middle years’ may see a further rise in suicide rates.”

The National Epidemiologic Survey on Alcohol and Related Conditions surveys were not conducted in clinical settings. Therefore, clinicians need to “look beyond the walls” of their health facilities to engage potentially vulnerable individuals and their families before they become suicidal.

Eric D. Caine, MD, is the chair of the department of psychiatry and codirector of the Center for Study and Prevention of Suicide at the University of Rochester (N.Y.). These remarks have been adapted from an editorial accompanying the article by Dr. Olfson and his associates (JAMA Psychiatry. 2017 Sep 13. doi: 10.1001/jamapsychiatry.2017.2524 ). He reported no financial disclosures.

Body

 

The findings by Mark Olfson, MD, MPH, and his associates “strongly echo” the discussions of Anne Case, PhD, and Angus Deaton, PhD, that underscore “the mortality rate effect of lower education levels, fundamental economic and vocational challenges, and social dislocation occurring in many communities across the United States.” But the work of Dr. Case and Dr. Deaton emphasizes that the biggest impact on deaths, including those caused by suicides, occurred in the middle years.

Meanwhile, findings from the National Violent Death Reporting System on suicide attempts in middle life show that more than two-thirds of men and more than 80% of women report having a disorder related to substance use or mental health, but only 25% of those men and 44% of those women ever received treatment for such conditions. The characteristics of these people, as recorded by the NVDRS, “fit into the populations discerned” by Dr. Case and Dr. Deaton. “While there are suggestions that the surveys used by Olfson et al. may not have been tuned to pick up the ‘signal’ that was associated with the rise in fatal suicide attempts during the first 15 years of the new century, they provided a clear warning that the coming generation of people aging into the ‘middle years’ may see a further rise in suicide rates.”

The National Epidemiologic Survey on Alcohol and Related Conditions surveys were not conducted in clinical settings. Therefore, clinicians need to “look beyond the walls” of their health facilities to engage potentially vulnerable individuals and their families before they become suicidal.

Eric D. Caine, MD, is the chair of the department of psychiatry and codirector of the Center for Study and Prevention of Suicide at the University of Rochester (N.Y.). These remarks have been adapted from an editorial accompanying the article by Dr. Olfson and his associates (JAMA Psychiatry. 2017 Sep 13. doi: 10.1001/jamapsychiatry.2017.2524 ). He reported no financial disclosures.

Title
Public health approach needed
Public health approach needed

Suicide attempts continue to increase in the United States, particularly among young adults with lower education levels and greater economic challenges, according to an analysis published Sept. 13.

These conclusions are based on data gleaned from two studies – the 2004-2005 wave 2 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-II) and the 2012-2013 NESARC-III. Of the 69,341 people surveyed, 57.2% were women, and the mean age was 48.1 years.

A wrist is shown wrapped in adhesive bandages with the word "HELP" spelled out across them.
ArishaRay/Thinkstock
Overall, the percentage of adults more than 21 years old who attempted suicide during the study periods increased significantly, from 0.62% in 2004-2005 to 0.79% in 2012-2013 (adjusted risk difference, 0.17%; 95% confidence interval, 0.01%-0.33%; P = .04), reported Mark Olfson, MD, of the department of psychiatry at Columbia University, New York, and his coauthors (JAMA Psychiatry. 2017 Sep 13. doi: 10.1001/jamapsychiatry.2017.2582).

However, the demographic groups that had the most notable increases were young adults aged 21-34 (ARD, 0.48%; 95% CI, 0.09%-0.87%; P = .02) and those with no more than a high school education (ADR, 0.49%; 95% CI, 0.18%-0.80%; P less than .002).

Dr. Olfson and his coauthors also found an increase in suicide attempts among adults with certain psychiatric disorders. Specifically, the risk for suicide attempts was higher for adults with antisocial personality disorder; among that group, the risk increased from 0.07% (95% CI, –0.09% to 0.23%) in 2004-2005 to 2.16% (95% CI, 0.61%-3.71%) in 2012-2013. “Other high-risk groups included persons with ... schizotypal ... personality disorders and those with anxiety and depressive disorders,” according to Dr. Olfson and his coauthors. “These findings highlight an increasing prevalence of suicide attempts and underscore the prominent role of mental disorders ... in risks for suicide attempts at the population level.”

Almost two-thirds of the adults who had recent suicide attempts in both NESARC survey groups had borderline personality disorder, the investigators reported. However, a finding the coauthors called “encouraging” is that “although most of the adults in the 2012-2013 survey who had recent suicide attempts had borderline personality disorder, the risk of attempted suicide among adults with borderline personality disorder significantly decreased during the study period,” Dr. Olfson and his coauthors wrote. They speculated that this decrease could be tied to findings showing that 40.8% of U.S. psychiatry residency programs offer training in dialectical behavior therapy for borderline personality disorder (Acad Psychiatry. 2013 Jul 1:37[4]:287-8). Clinician training programs are needed to help frontline clinicians manage self-harm among patients with borderline personality disorder, the investigators said.

In addition to many other risk factors, the investigators emphasized the correlation between recent suicide attempts and prior suicide attempts. About one-half of adults who reported a recent attempt also reported a prior attempt (95% CI, 16.46-33.67). “Because 15% to 25% of adults who die by suicide have received treatment for a suicide attempt within the past year, a substantial proportion of suicide deaths” could be subject to prior intervention that could be associated with an attempt, they said.

The data were limited in that adults who are homeless or incarcerated or who have schizophrenia were not surveyed. In addition, the coauthors cited the retrospective nature of NESARC self-reports as a limitation. Given the nature of the study, no data were collected from individuals who died of suicide. “This lack may have led to an underestimation of suicide attempts in each survey,” they wrote.

The study was supported by grants from the National Institutes of Health and the New York State Psychiatric Institute. The surveys were funded in part by the NIH Intramural Research Program. The authors did not report any financial disclosures.

Suicide attempts continue to increase in the United States, particularly among young adults with lower education levels and greater economic challenges, according to an analysis published Sept. 13.

These conclusions are based on data gleaned from two studies – the 2004-2005 wave 2 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-II) and the 2012-2013 NESARC-III. Of the 69,341 people surveyed, 57.2% were women, and the mean age was 48.1 years.

A wrist is shown wrapped in adhesive bandages with the word "HELP" spelled out across them.
ArishaRay/Thinkstock
Overall, the percentage of adults more than 21 years old who attempted suicide during the study periods increased significantly, from 0.62% in 2004-2005 to 0.79% in 2012-2013 (adjusted risk difference, 0.17%; 95% confidence interval, 0.01%-0.33%; P = .04), reported Mark Olfson, MD, of the department of psychiatry at Columbia University, New York, and his coauthors (JAMA Psychiatry. 2017 Sep 13. doi: 10.1001/jamapsychiatry.2017.2582).

However, the demographic groups that had the most notable increases were young adults aged 21-34 (ARD, 0.48%; 95% CI, 0.09%-0.87%; P = .02) and those with no more than a high school education (ADR, 0.49%; 95% CI, 0.18%-0.80%; P less than .002).

Dr. Olfson and his coauthors also found an increase in suicide attempts among adults with certain psychiatric disorders. Specifically, the risk for suicide attempts was higher for adults with antisocial personality disorder; among that group, the risk increased from 0.07% (95% CI, –0.09% to 0.23%) in 2004-2005 to 2.16% (95% CI, 0.61%-3.71%) in 2012-2013. “Other high-risk groups included persons with ... schizotypal ... personality disorders and those with anxiety and depressive disorders,” according to Dr. Olfson and his coauthors. “These findings highlight an increasing prevalence of suicide attempts and underscore the prominent role of mental disorders ... in risks for suicide attempts at the population level.”

Almost two-thirds of the adults who had recent suicide attempts in both NESARC survey groups had borderline personality disorder, the investigators reported. However, a finding the coauthors called “encouraging” is that “although most of the adults in the 2012-2013 survey who had recent suicide attempts had borderline personality disorder, the risk of attempted suicide among adults with borderline personality disorder significantly decreased during the study period,” Dr. Olfson and his coauthors wrote. They speculated that this decrease could be tied to findings showing that 40.8% of U.S. psychiatry residency programs offer training in dialectical behavior therapy for borderline personality disorder (Acad Psychiatry. 2013 Jul 1:37[4]:287-8). Clinician training programs are needed to help frontline clinicians manage self-harm among patients with borderline personality disorder, the investigators said.

In addition to many other risk factors, the investigators emphasized the correlation between recent suicide attempts and prior suicide attempts. About one-half of adults who reported a recent attempt also reported a prior attempt (95% CI, 16.46-33.67). “Because 15% to 25% of adults who die by suicide have received treatment for a suicide attempt within the past year, a substantial proportion of suicide deaths” could be subject to prior intervention that could be associated with an attempt, they said.

The data were limited in that adults who are homeless or incarcerated or who have schizophrenia were not surveyed. In addition, the coauthors cited the retrospective nature of NESARC self-reports as a limitation. Given the nature of the study, no data were collected from individuals who died of suicide. “This lack may have led to an underestimation of suicide attempts in each survey,” they wrote.

The study was supported by grants from the National Institutes of Health and the New York State Psychiatric Institute. The surveys were funded in part by the NIH Intramural Research Program. The authors did not report any financial disclosures.

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Key clinical point: Suicide attempts continue to rise, and the trend indicates a need for better awareness, intervention, and treatment.

Major finding: The percentage of adults over the age of 21 years who attempted suicide during the study period increased from 0.62% to 0.79% (adjusted risk difference, 0.17%; 95% confidence interval, 0.01%-0.33%; P = .04).

Data source: An analysis of the 2004-2005 wave 2 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-II) and the 2012-2013 NESARC-III.

Disclosures: This study was supported by grants from the National Institutes of Health and the New York State Psychiatric Institute. The surveys were funded in part by the NIH Intramural Research Program. The authors did not report any financial disclosures.

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Medical abortions provided via telemedicine appear safe

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Medical abortions using mifepristone and misoprostol to terminate a pregnancy up to 10 weeks of gestation were associated with similar rates of clinically significant adverse events whether the patient encounters occurred via telemedicine or in-office appointments, according to a retrospective cohort study published online in Obstetrics & Gynecology.

Dr. Daniel Grossman

Among the 8,765 medical abortions associated with telemedicine visits and the 10,405 associated with in-person visits at Planned Parenthood of the Heartland clinics in Iowa during the 7-year study period, a total of 49 clinically significant adverse events (hospital admission, blood transfusion, treatment given in an emergency department) were reported. There were no surgeries or deaths in the cohort. Of telemedicine patients, 0.18% had any clinically adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%), wrote Daniel Grossman, MD, of Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, and Kate Grindlay, MSPH, of IBIS Reproductive Health, Cambridge, Mass.


“In the 2 years after telemedicine was introduced at [these] clinics, women had an almost 50% higher adjusted odds of obtaining a first trimester abortion instead of a second-trimester abortion, [which] is associated with a higher risk of complications,” Dr. Grossman and Dr. Grindlay wrote. “Rather than increasing risks of abortion, it may be that telemedicine provision of medical abortion helps to reduce such risks by improving access to early abortion.”

Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

 

 

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Medical abortions using mifepristone and misoprostol to terminate a pregnancy up to 10 weeks of gestation were associated with similar rates of clinically significant adverse events whether the patient encounters occurred via telemedicine or in-office appointments, according to a retrospective cohort study published online in Obstetrics & Gynecology.

Dr. Daniel Grossman

Among the 8,765 medical abortions associated with telemedicine visits and the 10,405 associated with in-person visits at Planned Parenthood of the Heartland clinics in Iowa during the 7-year study period, a total of 49 clinically significant adverse events (hospital admission, blood transfusion, treatment given in an emergency department) were reported. There were no surgeries or deaths in the cohort. Of telemedicine patients, 0.18% had any clinically adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%), wrote Daniel Grossman, MD, of Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, and Kate Grindlay, MSPH, of IBIS Reproductive Health, Cambridge, Mass.


“In the 2 years after telemedicine was introduced at [these] clinics, women had an almost 50% higher adjusted odds of obtaining a first trimester abortion instead of a second-trimester abortion, [which] is associated with a higher risk of complications,” Dr. Grossman and Dr. Grindlay wrote. “Rather than increasing risks of abortion, it may be that telemedicine provision of medical abortion helps to reduce such risks by improving access to early abortion.”

Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

 

 

 

Medical abortions using mifepristone and misoprostol to terminate a pregnancy up to 10 weeks of gestation were associated with similar rates of clinically significant adverse events whether the patient encounters occurred via telemedicine or in-office appointments, according to a retrospective cohort study published online in Obstetrics & Gynecology.

Dr. Daniel Grossman

Among the 8,765 medical abortions associated with telemedicine visits and the 10,405 associated with in-person visits at Planned Parenthood of the Heartland clinics in Iowa during the 7-year study period, a total of 49 clinically significant adverse events (hospital admission, blood transfusion, treatment given in an emergency department) were reported. There were no surgeries or deaths in the cohort. Of telemedicine patients, 0.18% had any clinically adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%), wrote Daniel Grossman, MD, of Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, and Kate Grindlay, MSPH, of IBIS Reproductive Health, Cambridge, Mass.


“In the 2 years after telemedicine was introduced at [these] clinics, women had an almost 50% higher adjusted odds of obtaining a first trimester abortion instead of a second-trimester abortion, [which] is associated with a higher risk of complications,” Dr. Grossman and Dr. Grindlay wrote. “Rather than increasing risks of abortion, it may be that telemedicine provision of medical abortion helps to reduce such risks by improving access to early abortion.”

Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

 

 

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Key clinical point: Medical abortions after telemedicine appointments were associated with similar rates of clinically significant adverse events as those associated with in-person appointments.

Major finding: Of patients seen via telemedicine, 0.18% had any clinically significant adverse event (95% confidence interval, 0.11%-0.29%), compared with 0.32% of in-person patients (95% CI, 0.23%-0.45%).

Data source: A retrospective cohort study of 19,170 women who had received medical abortions at Planned Parenthood of the Heartland clinics in Iowa.

Disclosures: Dr. Grossman has served as a consultant to the Planned Parenthood Federation of America, providing input on the implementation of telemedicine services. Dr. Grindlay reported no financial disclosures.

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Poor smell predicts 6-year risk of Parkinson’s

Granularity needed in future studies
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Poor olfaction is a predictor of Parkinson’s disease (PD) in both the short and immediate term, with accuracy out to at least 6 years, especially in white men, according to a retrospective case adjudication of the Health ABC study published in Neurology.

Of 2,462 study participants, 42 were found to have PD during an average of 9.8 years of follow-up, Honglei Chen, MD, PhD, of the department of epidemiology and biostatistics at Michigan State University, East Lansing, and his coauthors wrote. Of those cases, 26 (62%) were associated with a poor Brief Smell Identification Test (BSIT) score of 0-8 out of 12 (hazard ratio, 5.1; 95% confidence interval, 2.1-11.9), supporting other studies that indicate that olfactory impairment is one of the early symptoms of PD.

Lonely/Thinkstock
Background with nose

In contrast to previous studies, however, “the current study has longer follow-up and showed that poor olfaction was associated with PD beyond the first [4] years of follow-up, although the association was somewhat attenuated,” the researchers said. Both before and after the first 5 years of follow-up, 13 people in the lowest BSIT tertile were diagnosed with PD (HR, 4.2; 95% CI, 1.7-10.8 vs. HR, 4.1; 95% CI, 1.7-9.8, respectively),

In addition, poor sense of smell was more clearly associated with PD diagnosis in white patients, Dr. Chen and her coauthors said. Of 30 PD diagnoses in white participants, 19 were associated with poor smell (HR, 4.9; 95% CI, 2.3-10.5), compared with 7 out of 12 diagnoses in black participants (HR, 2.5; 95% CI, 0.8-8.1; P = .3). Similarly, 19 out of 26 diagnoses in men were associated with poor smell (HR, 5.4; 95% CI, 2.3-12.9), compared with 7 out of 16 diagnoses in women (HR, 2.9; 95% CI, 1.1-7.8; P = .4).

Future studies should confirm these stratified findings. Olfactory dysfunction’s “potential usefulness as a screening tool for prodromal or undiagnosed PD in other general population awaits further investigations,” the authors said.

Dr. Chen reported editorial roles for a number of medical journals. None of the authors reported any financial disclosures.

Body

 

Olfactory dysfunction is high in Parkinson’s disease, and the study by Chen et al. is the first to describe the natural history of olfactory dysfunction in the evolution of PD prior to diagnosis in diverse populations with extended periods of follow-up.

The length of follow-up is the longest to date, and includes important data on a large cohort of black participants. The results are a start for creating a much needed preventional paradigm, but more granularity will be needed to determine how poor smell, especially as stratified by race and sex, might help in prevention and treatment of PD.

Gene L. Bowman, ND, MPH, is a physician in the department of neurology at Oregon Health & Science University, Portland. His editorial comments accompanied the Chen et al. article in Neurology. He reported no financial disclosures.

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Olfactory dysfunction is high in Parkinson’s disease, and the study by Chen et al. is the first to describe the natural history of olfactory dysfunction in the evolution of PD prior to diagnosis in diverse populations with extended periods of follow-up.

The length of follow-up is the longest to date, and includes important data on a large cohort of black participants. The results are a start for creating a much needed preventional paradigm, but more granularity will be needed to determine how poor smell, especially as stratified by race and sex, might help in prevention and treatment of PD.

Gene L. Bowman, ND, MPH, is a physician in the department of neurology at Oregon Health & Science University, Portland. His editorial comments accompanied the Chen et al. article in Neurology. He reported no financial disclosures.

Body

 

Olfactory dysfunction is high in Parkinson’s disease, and the study by Chen et al. is the first to describe the natural history of olfactory dysfunction in the evolution of PD prior to diagnosis in diverse populations with extended periods of follow-up.

The length of follow-up is the longest to date, and includes important data on a large cohort of black participants. The results are a start for creating a much needed preventional paradigm, but more granularity will be needed to determine how poor smell, especially as stratified by race and sex, might help in prevention and treatment of PD.

Gene L. Bowman, ND, MPH, is a physician in the department of neurology at Oregon Health & Science University, Portland. His editorial comments accompanied the Chen et al. article in Neurology. He reported no financial disclosures.

Title
Granularity needed in future studies
Granularity needed in future studies

 

Poor olfaction is a predictor of Parkinson’s disease (PD) in both the short and immediate term, with accuracy out to at least 6 years, especially in white men, according to a retrospective case adjudication of the Health ABC study published in Neurology.

Of 2,462 study participants, 42 were found to have PD during an average of 9.8 years of follow-up, Honglei Chen, MD, PhD, of the department of epidemiology and biostatistics at Michigan State University, East Lansing, and his coauthors wrote. Of those cases, 26 (62%) were associated with a poor Brief Smell Identification Test (BSIT) score of 0-8 out of 12 (hazard ratio, 5.1; 95% confidence interval, 2.1-11.9), supporting other studies that indicate that olfactory impairment is one of the early symptoms of PD.

Lonely/Thinkstock
Background with nose

In contrast to previous studies, however, “the current study has longer follow-up and showed that poor olfaction was associated with PD beyond the first [4] years of follow-up, although the association was somewhat attenuated,” the researchers said. Both before and after the first 5 years of follow-up, 13 people in the lowest BSIT tertile were diagnosed with PD (HR, 4.2; 95% CI, 1.7-10.8 vs. HR, 4.1; 95% CI, 1.7-9.8, respectively),

In addition, poor sense of smell was more clearly associated with PD diagnosis in white patients, Dr. Chen and her coauthors said. Of 30 PD diagnoses in white participants, 19 were associated with poor smell (HR, 4.9; 95% CI, 2.3-10.5), compared with 7 out of 12 diagnoses in black participants (HR, 2.5; 95% CI, 0.8-8.1; P = .3). Similarly, 19 out of 26 diagnoses in men were associated with poor smell (HR, 5.4; 95% CI, 2.3-12.9), compared with 7 out of 16 diagnoses in women (HR, 2.9; 95% CI, 1.1-7.8; P = .4).

Future studies should confirm these stratified findings. Olfactory dysfunction’s “potential usefulness as a screening tool for prodromal or undiagnosed PD in other general population awaits further investigations,” the authors said.

Dr. Chen reported editorial roles for a number of medical journals. None of the authors reported any financial disclosures.

 

Poor olfaction is a predictor of Parkinson’s disease (PD) in both the short and immediate term, with accuracy out to at least 6 years, especially in white men, according to a retrospective case adjudication of the Health ABC study published in Neurology.

Of 2,462 study participants, 42 were found to have PD during an average of 9.8 years of follow-up, Honglei Chen, MD, PhD, of the department of epidemiology and biostatistics at Michigan State University, East Lansing, and his coauthors wrote. Of those cases, 26 (62%) were associated with a poor Brief Smell Identification Test (BSIT) score of 0-8 out of 12 (hazard ratio, 5.1; 95% confidence interval, 2.1-11.9), supporting other studies that indicate that olfactory impairment is one of the early symptoms of PD.

Lonely/Thinkstock
Background with nose

In contrast to previous studies, however, “the current study has longer follow-up and showed that poor olfaction was associated with PD beyond the first [4] years of follow-up, although the association was somewhat attenuated,” the researchers said. Both before and after the first 5 years of follow-up, 13 people in the lowest BSIT tertile were diagnosed with PD (HR, 4.2; 95% CI, 1.7-10.8 vs. HR, 4.1; 95% CI, 1.7-9.8, respectively),

In addition, poor sense of smell was more clearly associated with PD diagnosis in white patients, Dr. Chen and her coauthors said. Of 30 PD diagnoses in white participants, 19 were associated with poor smell (HR, 4.9; 95% CI, 2.3-10.5), compared with 7 out of 12 diagnoses in black participants (HR, 2.5; 95% CI, 0.8-8.1; P = .3). Similarly, 19 out of 26 diagnoses in men were associated with poor smell (HR, 5.4; 95% CI, 2.3-12.9), compared with 7 out of 16 diagnoses in women (HR, 2.9; 95% CI, 1.1-7.8; P = .4).

Future studies should confirm these stratified findings. Olfactory dysfunction’s “potential usefulness as a screening tool for prodromal or undiagnosed PD in other general population awaits further investigations,” the authors said.

Dr. Chen reported editorial roles for a number of medical journals. None of the authors reported any financial disclosures.

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Key clinical point: Poor olfaction is a predictor of Parkinson’s disease (PD) in both the short and immediate term, with accuracy out to at least 6 years, especially in white men.

Major finding: Both before and after the first 5 years of follow-up, 13 people in the lowest BSIT tertile were diagnosed with PD (HR, 4.2; 95% CI, 1.7-10.8 vs. HR, 4.1; 95% CI, 1.7-9.8, respectively).

Data source: A retrospective case adjudication of PD cases diagnosed in the Health ABC study.

Disclosures: Dr. Chen reported editorial roles for a number of medical journals. None of the authors reported any financial disclosures.

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FDA approves Vabomere for complicated UTI in adults

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The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.

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Vabomere contains meropenem, an antibacterial, and vaborbactam, a potent selective beta-lactamase inhibitor. The drug is administered intravenously, and the recommended dosage is 4 grams (meropenem 2 grams and vaborbactam 2 grams) in a 3-hour infusion every 8 hours in patients aged 18 and older, the drug’s developer, The Medicines Company, said in a statement released Aug. 30. The recommended duration of treatment for Vabomere is up to 14 days.

Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.

“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.

Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.

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The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.

FDA icon
Vabomere contains meropenem, an antibacterial, and vaborbactam, a potent selective beta-lactamase inhibitor. The drug is administered intravenously, and the recommended dosage is 4 grams (meropenem 2 grams and vaborbactam 2 grams) in a 3-hour infusion every 8 hours in patients aged 18 and older, the drug’s developer, The Medicines Company, said in a statement released Aug. 30. The recommended duration of treatment for Vabomere is up to 14 days.

Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.

“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.

Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.

 

The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.

FDA icon
Vabomere contains meropenem, an antibacterial, and vaborbactam, a potent selective beta-lactamase inhibitor. The drug is administered intravenously, and the recommended dosage is 4 grams (meropenem 2 grams and vaborbactam 2 grams) in a 3-hour infusion every 8 hours in patients aged 18 and older, the drug’s developer, The Medicines Company, said in a statement released Aug. 30. The recommended duration of treatment for Vabomere is up to 14 days.

Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.

“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.

Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.

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FDA grants breakthrough status to epidermolysis bullosa gene therapy

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Mon, 01/14/2019 - 10:08

 

The U.S. Food and Drug Administration has granted breakthrough therapy status to Abeona Therapeutics’s EB-101 gene therapy program for patients with recessive dystrophic epidermolysis bullosa, according to a company statement.

The breakthrough therapy designation will expedite the phase 3 trial, intended to start in 2018, and the approval process and make this therapy available to patients who have few or no other treatment options for this serious and painful condition.

FDA icon
In the phase 1/2 clinical trial, EB-101, an autologous, ex vivo gene-corrected cell therapy in which the COL7A1 gene is inserted into a patient’s own skin cells, was administered to nonhealing chronic wounds. When compared with untreated control wounds, treated wounds were significantly healed (greater than 50% healed) for more than 2 years after administration in all 128 evaluated patients.

The experimental treatment “utilizes a patient’s own cells and genetically engineer[s] them to produce the correct version of collagen, which helps hold skin on to the body, thereby reducing the number of painful blisters caused by injury and improving wound healing,” Timothy J. Miller, PhD, CEO and president of Abeona, said in a statement. “We are grateful that the FDA has recognized the promising clinical data from the EB-101 program with Breakthrough Therapy designation.”

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The U.S. Food and Drug Administration has granted breakthrough therapy status to Abeona Therapeutics’s EB-101 gene therapy program for patients with recessive dystrophic epidermolysis bullosa, according to a company statement.

The breakthrough therapy designation will expedite the phase 3 trial, intended to start in 2018, and the approval process and make this therapy available to patients who have few or no other treatment options for this serious and painful condition.

FDA icon
In the phase 1/2 clinical trial, EB-101, an autologous, ex vivo gene-corrected cell therapy in which the COL7A1 gene is inserted into a patient’s own skin cells, was administered to nonhealing chronic wounds. When compared with untreated control wounds, treated wounds were significantly healed (greater than 50% healed) for more than 2 years after administration in all 128 evaluated patients.

The experimental treatment “utilizes a patient’s own cells and genetically engineer[s] them to produce the correct version of collagen, which helps hold skin on to the body, thereby reducing the number of painful blisters caused by injury and improving wound healing,” Timothy J. Miller, PhD, CEO and president of Abeona, said in a statement. “We are grateful that the FDA has recognized the promising clinical data from the EB-101 program with Breakthrough Therapy designation.”

 

The U.S. Food and Drug Administration has granted breakthrough therapy status to Abeona Therapeutics’s EB-101 gene therapy program for patients with recessive dystrophic epidermolysis bullosa, according to a company statement.

The breakthrough therapy designation will expedite the phase 3 trial, intended to start in 2018, and the approval process and make this therapy available to patients who have few or no other treatment options for this serious and painful condition.

FDA icon
In the phase 1/2 clinical trial, EB-101, an autologous, ex vivo gene-corrected cell therapy in which the COL7A1 gene is inserted into a patient’s own skin cells, was administered to nonhealing chronic wounds. When compared with untreated control wounds, treated wounds were significantly healed (greater than 50% healed) for more than 2 years after administration in all 128 evaluated patients.

The experimental treatment “utilizes a patient’s own cells and genetically engineer[s] them to produce the correct version of collagen, which helps hold skin on to the body, thereby reducing the number of painful blisters caused by injury and improving wound healing,” Timothy J. Miller, PhD, CEO and president of Abeona, said in a statement. “We are grateful that the FDA has recognized the promising clinical data from the EB-101 program with Breakthrough Therapy designation.”

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FDA expands approval of fulvestrant for HR+/HER2– advanced breast cancer

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Thu, 12/15/2022 - 17:52

The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release.

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Median PFS was 16.6 months in the fulvestrant group versus 13.8 months in the anastrozole group (hazard ratio, 0.797; 95% confidence interval, 0.637-0.999; P = .049).

The most common adverse events were arthralgia (16.7% of patients on fulvestrant vs. 10.3% on anastrozole), and hot flushes/flashes (11.4% vs. 10.3%).

Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole, according to results published in The Lancet.

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The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release.

FDA icon
Median PFS was 16.6 months in the fulvestrant group versus 13.8 months in the anastrozole group (hazard ratio, 0.797; 95% confidence interval, 0.637-0.999; P = .049).

The most common adverse events were arthralgia (16.7% of patients on fulvestrant vs. 10.3% on anastrozole), and hot flushes/flashes (11.4% vs. 10.3%).

Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole, according to results published in The Lancet.

The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release.

FDA icon
Median PFS was 16.6 months in the fulvestrant group versus 13.8 months in the anastrozole group (hazard ratio, 0.797; 95% confidence interval, 0.637-0.999; P = .049).

The most common adverse events were arthralgia (16.7% of patients on fulvestrant vs. 10.3% on anastrozole), and hot flushes/flashes (11.4% vs. 10.3%).

Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole, according to results published in The Lancet.

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Reimmunization appears safe in children with history of adverse events

Talking about vaccine adverse events is challenging
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Fri, 01/18/2019 - 16:59

Reimmunization appears to be safe for patients with mild to moderate adverse events following immunization (AEFI), but there are not enough data to make firm conclusions about severe AEFIs, according to a systematic review of studies that were published in English and French between 1982 and 2016 and were made available to Medline via PubMed, Embase, and the Cochrane library.

Vaccine chart
dina2001/Thinkstock
The review, published in Pediatrics (2017 Aug. doi: 10.1542.peds.2016-3707), looked at 29 studies. Of those, eight collectively found that allergic-like events recurred in 30 of 594 patients (5%; 95% confidence interval, 3.3-6.8), Joseline Guetsop Zafack, MD, MPH, of the department of social and preventive medicine at Laval University in Quebec, and her coauthors reported. They noted that “recurrences did not dissuade patients from continuing immunization.” In the six studies that looked at recurrence of hypotonic-hyporesponsive episodes, only 3 of 398 patients had a recurrence (0.8%; 95% CI, 0.2-2.2). None of three studies found recurrence of seizure in children who were reimmunized..

Apnea was found to be of concern only in children under the age of 1 year and usually found only in lower birth weight babies and those with ongoing hospitalization for complications related to prematurity, the investigators said. A 10-g increase in birth weight was associated with a 6% reduction in risk of apnea recurrence (odds ratio, 0.94; 95% CI, 0.89-1.00), and odds of recurrence were 23 times higher in infants hospitalized for complications related to prematurity (OR, 23; 95% CI, 2-272).

Some of the studies also evaluated for injection site reactions, Henoch-Schönlein purpura, or other AEFI, Dr. Zafack and her coauthors continued. Injection site reactions varied depending on vaccine and number of doses, but all children recovered within 19 days of immunization. Only one child in one study had a recurrence of Henoch-Schönlein purpura. Vomiting, persistent crying, decreased appetite, and drowsiness recurred in 15%, 24%, 25%, and 35% of the reimmunized patients, respectively, across all the studies.

“In a context of vaccine hesitancy and growing concerns regarding vaccine safety, evaluating the risk of recurrence of all AEFIs should become part of the standard evaluation of vaccine safety,” the researchers wrote. “Reimmunization appears to be safe for patients with mild to moderate AEFIs. However, the data are insufficient to draw firm conclusions regarding the safety of reimmunization after a severe AEFI.”

In this study, “it appears that the risk of recurrence of serious AEFIs (anaphylaxis, seizures, or apnea in term infants) was low (less than 1%). For minor to moderate AEFIs (fever, extensive limb swelling, oculorespiratory syndrome, allergic-like events, sleepiness, thrombocytopenia, decreased appetite, vomiting, or persistent crying), the risk of recurrence ranged from 4% to 48%,” the investigators concluded.

The study was funded by the Canadian Immunization Research Network, which is sponsored by the Public Health Agency of Canada and the Canadian Institutes of Health Research. Dr. Zafack reported no financial disclosures. Some of her coauthors reported financial support from GlaxoSmithKline and Pfizer.

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There are few experiences more challenging for a pediatrician than trying to convince a parent to continue vaccinating his or her child after witnessing a seemingly related adverse event following immunization (AEFI). The question they want answered is, Will it happen again?

Zafack et al. have sought to answer that question by providing previously lacking estimates of the risk of recurrence. By consolidating the data available in a range of literature, they showed that the risk of a serious AEFI is less than 1%. More accurate risk assessments also are available for mild to moderate AEFI for many vaccines.

The Zafack et al. article also reinforces what vaccinologists and pediatricians have known for many years: Vaccines are incredibly safe. Vaccines are administered to millions of children every year, and the list of known adverse events still is very short. The researchers reaffirm the overwhelming value and safety of vaccines that protect infants and children from complications and death resulting from infectious diseases.

Even though this article does not address AEFI risk for all vaccines, it is impressively comprehensive and will be a useful reference for practicing pediatricians everywhere for years to come.
 

Sean T. O’Leary, MD, MPH , is an associate professor in the division of infectious diseases in the department of pediatrics at the University of Colorado at Denver, Aurora. Yvonne A. Maldonado, MD , is chief of the division of pediatric infectious diseases and a professor of pediatrics at Stanford (Calif.) University. She serves on a Data Safety Monitoring Board for a Pfizer vaccine trial. Both authors are members of the American Academy of Pediatrics committee on infectious disease and subcommittee on vaccine policy and vaccine hesitancy. These comments were published in an editorial accompanying the Zafack et al. article in Pediatrics (2017. doi: 10.1542/peds.2017-1760 ).

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There are few experiences more challenging for a pediatrician than trying to convince a parent to continue vaccinating his or her child after witnessing a seemingly related adverse event following immunization (AEFI). The question they want answered is, Will it happen again?

Zafack et al. have sought to answer that question by providing previously lacking estimates of the risk of recurrence. By consolidating the data available in a range of literature, they showed that the risk of a serious AEFI is less than 1%. More accurate risk assessments also are available for mild to moderate AEFI for many vaccines.

The Zafack et al. article also reinforces what vaccinologists and pediatricians have known for many years: Vaccines are incredibly safe. Vaccines are administered to millions of children every year, and the list of known adverse events still is very short. The researchers reaffirm the overwhelming value and safety of vaccines that protect infants and children from complications and death resulting from infectious diseases.

Even though this article does not address AEFI risk for all vaccines, it is impressively comprehensive and will be a useful reference for practicing pediatricians everywhere for years to come.
 

Sean T. O’Leary, MD, MPH , is an associate professor in the division of infectious diseases in the department of pediatrics at the University of Colorado at Denver, Aurora. Yvonne A. Maldonado, MD , is chief of the division of pediatric infectious diseases and a professor of pediatrics at Stanford (Calif.) University. She serves on a Data Safety Monitoring Board for a Pfizer vaccine trial. Both authors are members of the American Academy of Pediatrics committee on infectious disease and subcommittee on vaccine policy and vaccine hesitancy. These comments were published in an editorial accompanying the Zafack et al. article in Pediatrics (2017. doi: 10.1542/peds.2017-1760 ).

Body

 

There are few experiences more challenging for a pediatrician than trying to convince a parent to continue vaccinating his or her child after witnessing a seemingly related adverse event following immunization (AEFI). The question they want answered is, Will it happen again?

Zafack et al. have sought to answer that question by providing previously lacking estimates of the risk of recurrence. By consolidating the data available in a range of literature, they showed that the risk of a serious AEFI is less than 1%. More accurate risk assessments also are available for mild to moderate AEFI for many vaccines.

The Zafack et al. article also reinforces what vaccinologists and pediatricians have known for many years: Vaccines are incredibly safe. Vaccines are administered to millions of children every year, and the list of known adverse events still is very short. The researchers reaffirm the overwhelming value and safety of vaccines that protect infants and children from complications and death resulting from infectious diseases.

Even though this article does not address AEFI risk for all vaccines, it is impressively comprehensive and will be a useful reference for practicing pediatricians everywhere for years to come.
 

Sean T. O’Leary, MD, MPH , is an associate professor in the division of infectious diseases in the department of pediatrics at the University of Colorado at Denver, Aurora. Yvonne A. Maldonado, MD , is chief of the division of pediatric infectious diseases and a professor of pediatrics at Stanford (Calif.) University. She serves on a Data Safety Monitoring Board for a Pfizer vaccine trial. Both authors are members of the American Academy of Pediatrics committee on infectious disease and subcommittee on vaccine policy and vaccine hesitancy. These comments were published in an editorial accompanying the Zafack et al. article in Pediatrics (2017. doi: 10.1542/peds.2017-1760 ).

Title
Talking about vaccine adverse events is challenging
Talking about vaccine adverse events is challenging

Reimmunization appears to be safe for patients with mild to moderate adverse events following immunization (AEFI), but there are not enough data to make firm conclusions about severe AEFIs, according to a systematic review of studies that were published in English and French between 1982 and 2016 and were made available to Medline via PubMed, Embase, and the Cochrane library.

Vaccine chart
dina2001/Thinkstock
The review, published in Pediatrics (2017 Aug. doi: 10.1542.peds.2016-3707), looked at 29 studies. Of those, eight collectively found that allergic-like events recurred in 30 of 594 patients (5%; 95% confidence interval, 3.3-6.8), Joseline Guetsop Zafack, MD, MPH, of the department of social and preventive medicine at Laval University in Quebec, and her coauthors reported. They noted that “recurrences did not dissuade patients from continuing immunization.” In the six studies that looked at recurrence of hypotonic-hyporesponsive episodes, only 3 of 398 patients had a recurrence (0.8%; 95% CI, 0.2-2.2). None of three studies found recurrence of seizure in children who were reimmunized..

Apnea was found to be of concern only in children under the age of 1 year and usually found only in lower birth weight babies and those with ongoing hospitalization for complications related to prematurity, the investigators said. A 10-g increase in birth weight was associated with a 6% reduction in risk of apnea recurrence (odds ratio, 0.94; 95% CI, 0.89-1.00), and odds of recurrence were 23 times higher in infants hospitalized for complications related to prematurity (OR, 23; 95% CI, 2-272).

Some of the studies also evaluated for injection site reactions, Henoch-Schönlein purpura, or other AEFI, Dr. Zafack and her coauthors continued. Injection site reactions varied depending on vaccine and number of doses, but all children recovered within 19 days of immunization. Only one child in one study had a recurrence of Henoch-Schönlein purpura. Vomiting, persistent crying, decreased appetite, and drowsiness recurred in 15%, 24%, 25%, and 35% of the reimmunized patients, respectively, across all the studies.

“In a context of vaccine hesitancy and growing concerns regarding vaccine safety, evaluating the risk of recurrence of all AEFIs should become part of the standard evaluation of vaccine safety,” the researchers wrote. “Reimmunization appears to be safe for patients with mild to moderate AEFIs. However, the data are insufficient to draw firm conclusions regarding the safety of reimmunization after a severe AEFI.”

In this study, “it appears that the risk of recurrence of serious AEFIs (anaphylaxis, seizures, or apnea in term infants) was low (less than 1%). For minor to moderate AEFIs (fever, extensive limb swelling, oculorespiratory syndrome, allergic-like events, sleepiness, thrombocytopenia, decreased appetite, vomiting, or persistent crying), the risk of recurrence ranged from 4% to 48%,” the investigators concluded.

The study was funded by the Canadian Immunization Research Network, which is sponsored by the Public Health Agency of Canada and the Canadian Institutes of Health Research. Dr. Zafack reported no financial disclosures. Some of her coauthors reported financial support from GlaxoSmithKline and Pfizer.

Reimmunization appears to be safe for patients with mild to moderate adverse events following immunization (AEFI), but there are not enough data to make firm conclusions about severe AEFIs, according to a systematic review of studies that were published in English and French between 1982 and 2016 and were made available to Medline via PubMed, Embase, and the Cochrane library.

Vaccine chart
dina2001/Thinkstock
The review, published in Pediatrics (2017 Aug. doi: 10.1542.peds.2016-3707), looked at 29 studies. Of those, eight collectively found that allergic-like events recurred in 30 of 594 patients (5%; 95% confidence interval, 3.3-6.8), Joseline Guetsop Zafack, MD, MPH, of the department of social and preventive medicine at Laval University in Quebec, and her coauthors reported. They noted that “recurrences did not dissuade patients from continuing immunization.” In the six studies that looked at recurrence of hypotonic-hyporesponsive episodes, only 3 of 398 patients had a recurrence (0.8%; 95% CI, 0.2-2.2). None of three studies found recurrence of seizure in children who were reimmunized..

Apnea was found to be of concern only in children under the age of 1 year and usually found only in lower birth weight babies and those with ongoing hospitalization for complications related to prematurity, the investigators said. A 10-g increase in birth weight was associated with a 6% reduction in risk of apnea recurrence (odds ratio, 0.94; 95% CI, 0.89-1.00), and odds of recurrence were 23 times higher in infants hospitalized for complications related to prematurity (OR, 23; 95% CI, 2-272).

Some of the studies also evaluated for injection site reactions, Henoch-Schönlein purpura, or other AEFI, Dr. Zafack and her coauthors continued. Injection site reactions varied depending on vaccine and number of doses, but all children recovered within 19 days of immunization. Only one child in one study had a recurrence of Henoch-Schönlein purpura. Vomiting, persistent crying, decreased appetite, and drowsiness recurred in 15%, 24%, 25%, and 35% of the reimmunized patients, respectively, across all the studies.

“In a context of vaccine hesitancy and growing concerns regarding vaccine safety, evaluating the risk of recurrence of all AEFIs should become part of the standard evaluation of vaccine safety,” the researchers wrote. “Reimmunization appears to be safe for patients with mild to moderate AEFIs. However, the data are insufficient to draw firm conclusions regarding the safety of reimmunization after a severe AEFI.”

In this study, “it appears that the risk of recurrence of serious AEFIs (anaphylaxis, seizures, or apnea in term infants) was low (less than 1%). For minor to moderate AEFIs (fever, extensive limb swelling, oculorespiratory syndrome, allergic-like events, sleepiness, thrombocytopenia, decreased appetite, vomiting, or persistent crying), the risk of recurrence ranged from 4% to 48%,” the investigators concluded.

The study was funded by the Canadian Immunization Research Network, which is sponsored by the Public Health Agency of Canada and the Canadian Institutes of Health Research. Dr. Zafack reported no financial disclosures. Some of her coauthors reported financial support from GlaxoSmithKline and Pfizer.

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Key clinical point: Reimmunization appears to be safe for patients with mild to moderate adverse events following immunization.

Major finding: The risk of a serious AEFI is less than 1%. More accurate risk assessments also are available for mild to moderate AEFI.

Data source: A systematic review of 29 studies assessing the risks of AEFI.

Disclosures: The study was funded by the Canadian Immunization Research Network, which is sponsored by the Public Health Agency of Canada and the Canadian Institutes of Health Research. Dr. Zafack reported no financial disclosures. Some of her coauthors reported financial support from GlaxoSmithKline and Pfizer.

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Recommendations for infant sleep position are not being followed

Clear, consistent message is needed
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Fri, 01/18/2019 - 16:58

 

Despite the American Academy of Pediatrics recommendation that parents place infants supine for sleeping, many mothers do not do so, according to the results of the Study of Attitudes and Factors Affecting Infant Care.

Baby in supine position


Several other discrepancies in compliance with the AAP recommendation also were noted. African American mothers were more likely to intend to use prone position, compared with white mothers (adjusted odds ratio, 2.5; 95% confidence interval, 1.57-3.85). Those who did not complete high school were also more likely to intend to use the prone position (aOR, 2.1; 95% CI, 1.16-3.73). On the other hand, those who received recommendation-compliant advice from a doctor were less likely to place their infants in the prone (aOR, 0.6; 95% CI, 0.39-0.93) or side (aOR, 0.5; 95% CI, 0.36-0.67) positions.

“Of particular note, those who reported that their social norms supported placing the infant in the prone position were much more likely to do so, compared with those who felt that their social norms supported using only the supine position (aOR, 11.6; 95% CI, 7.24-18.7). And, most remarkably, those who had positive attitudes about the prone sleep position ... were more likely to choose the prone position (aOR, 130; 95% CI, 71.8-236),” the researchers wrote. These findings indicate that choices in infant sleeping position are directly influenced by attitudes toward the choice, subjective social norms, and perceptions about control.

“These beliefs persist and are potentially modifiable, so they should be considered an important part of any intervention to change practice,” Dr. Colson and her colleagues wrote.

The study was a nationally representative sample of mothers of infants aged 2-6 months. Although the data were taken from patient surveys, which could have been misreported, they are supported by the findings of other studies.

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Over the 10 years spanning 1994-2004, the sudden infant death syndrome rate in the United States fell by 53%, correlating with an increase in exclusive supine sleep from less than 10% to 78%. However, since then, rates of both supine sleep and SIDS death have remained stagnant.

To make progress in these areas, current data are needed on supine sleep to enhance understanding of how families make these decisions. Colson et al. provide exactly the kind of information we need to guide providers and public health officials in their efforts to help families maintain the safest sleep environments for their infants.

As a start, mothers who want to practice safe sleep need to be empowered to insist that other caregivers in their lives support their parenting decisions, because the study shows that mothers who feel that they have more control are more likely to use the recommended position. We also must look at how we can help change personal attitudes and societal norms in favor of supine sleep because these issues were found to be some of the strongest predictors of prone sleep position.

We, as health care providers, need to provide clear and consistent messaging in both word and behavior to help mothers make safe decisions for their infants.
 

Michael H. Goodstein, MD, is a neonatologist at WellSpan York (Pa.) Hospital. Barbara M. Ostfeld, PhD, is the program director of the SIDS Center of New Jersey at Rutgers University, New Brunswick. Their remarks accompanied the article by Colson et al. (Pediatrics 2017 Aug 21. doi: 10.1542/peds.2017-2068). Neither author reported any financial disclosures.

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Over the 10 years spanning 1994-2004, the sudden infant death syndrome rate in the United States fell by 53%, correlating with an increase in exclusive supine sleep from less than 10% to 78%. However, since then, rates of both supine sleep and SIDS death have remained stagnant.

To make progress in these areas, current data are needed on supine sleep to enhance understanding of how families make these decisions. Colson et al. provide exactly the kind of information we need to guide providers and public health officials in their efforts to help families maintain the safest sleep environments for their infants.

As a start, mothers who want to practice safe sleep need to be empowered to insist that other caregivers in their lives support their parenting decisions, because the study shows that mothers who feel that they have more control are more likely to use the recommended position. We also must look at how we can help change personal attitudes and societal norms in favor of supine sleep because these issues were found to be some of the strongest predictors of prone sleep position.

We, as health care providers, need to provide clear and consistent messaging in both word and behavior to help mothers make safe decisions for their infants.
 

Michael H. Goodstein, MD, is a neonatologist at WellSpan York (Pa.) Hospital. Barbara M. Ostfeld, PhD, is the program director of the SIDS Center of New Jersey at Rutgers University, New Brunswick. Their remarks accompanied the article by Colson et al. (Pediatrics 2017 Aug 21. doi: 10.1542/peds.2017-2068). Neither author reported any financial disclosures.

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Over the 10 years spanning 1994-2004, the sudden infant death syndrome rate in the United States fell by 53%, correlating with an increase in exclusive supine sleep from less than 10% to 78%. However, since then, rates of both supine sleep and SIDS death have remained stagnant.

To make progress in these areas, current data are needed on supine sleep to enhance understanding of how families make these decisions. Colson et al. provide exactly the kind of information we need to guide providers and public health officials in their efforts to help families maintain the safest sleep environments for their infants.

As a start, mothers who want to practice safe sleep need to be empowered to insist that other caregivers in their lives support their parenting decisions, because the study shows that mothers who feel that they have more control are more likely to use the recommended position. We also must look at how we can help change personal attitudes and societal norms in favor of supine sleep because these issues were found to be some of the strongest predictors of prone sleep position.

We, as health care providers, need to provide clear and consistent messaging in both word and behavior to help mothers make safe decisions for their infants.
 

Michael H. Goodstein, MD, is a neonatologist at WellSpan York (Pa.) Hospital. Barbara M. Ostfeld, PhD, is the program director of the SIDS Center of New Jersey at Rutgers University, New Brunswick. Their remarks accompanied the article by Colson et al. (Pediatrics 2017 Aug 21. doi: 10.1542/peds.2017-2068). Neither author reported any financial disclosures.

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Clear, consistent message is needed
Clear, consistent message is needed

 

Despite the American Academy of Pediatrics recommendation that parents place infants supine for sleeping, many mothers do not do so, according to the results of the Study of Attitudes and Factors Affecting Infant Care.

Baby in supine position


Several other discrepancies in compliance with the AAP recommendation also were noted. African American mothers were more likely to intend to use prone position, compared with white mothers (adjusted odds ratio, 2.5; 95% confidence interval, 1.57-3.85). Those who did not complete high school were also more likely to intend to use the prone position (aOR, 2.1; 95% CI, 1.16-3.73). On the other hand, those who received recommendation-compliant advice from a doctor were less likely to place their infants in the prone (aOR, 0.6; 95% CI, 0.39-0.93) or side (aOR, 0.5; 95% CI, 0.36-0.67) positions.

“Of particular note, those who reported that their social norms supported placing the infant in the prone position were much more likely to do so, compared with those who felt that their social norms supported using only the supine position (aOR, 11.6; 95% CI, 7.24-18.7). And, most remarkably, those who had positive attitudes about the prone sleep position ... were more likely to choose the prone position (aOR, 130; 95% CI, 71.8-236),” the researchers wrote. These findings indicate that choices in infant sleeping position are directly influenced by attitudes toward the choice, subjective social norms, and perceptions about control.

“These beliefs persist and are potentially modifiable, so they should be considered an important part of any intervention to change practice,” Dr. Colson and her colleagues wrote.

The study was a nationally representative sample of mothers of infants aged 2-6 months. Although the data were taken from patient surveys, which could have been misreported, they are supported by the findings of other studies.

 

Despite the American Academy of Pediatrics recommendation that parents place infants supine for sleeping, many mothers do not do so, according to the results of the Study of Attitudes and Factors Affecting Infant Care.

Baby in supine position


Several other discrepancies in compliance with the AAP recommendation also were noted. African American mothers were more likely to intend to use prone position, compared with white mothers (adjusted odds ratio, 2.5; 95% confidence interval, 1.57-3.85). Those who did not complete high school were also more likely to intend to use the prone position (aOR, 2.1; 95% CI, 1.16-3.73). On the other hand, those who received recommendation-compliant advice from a doctor were less likely to place their infants in the prone (aOR, 0.6; 95% CI, 0.39-0.93) or side (aOR, 0.5; 95% CI, 0.36-0.67) positions.

“Of particular note, those who reported that their social norms supported placing the infant in the prone position were much more likely to do so, compared with those who felt that their social norms supported using only the supine position (aOR, 11.6; 95% CI, 7.24-18.7). And, most remarkably, those who had positive attitudes about the prone sleep position ... were more likely to choose the prone position (aOR, 130; 95% CI, 71.8-236),” the researchers wrote. These findings indicate that choices in infant sleeping position are directly influenced by attitudes toward the choice, subjective social norms, and perceptions about control.

“These beliefs persist and are potentially modifiable, so they should be considered an important part of any intervention to change practice,” Dr. Colson and her colleagues wrote.

The study was a nationally representative sample of mothers of infants aged 2-6 months. Although the data were taken from patient surveys, which could have been misreported, they are supported by the findings of other studies.

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Key clinical point: Despite the American Academy of Pediatrics recommendation that parents place infants supine for sleeping, many mothers do not do so.

Major finding: Of the 3,297 mothers surveyed, 2,491 (77%) reported that they usually place their infants in supine position, but only 49% reported that they exclusively place their infants supine.

Data source: The Study of Attitudes and Factors Affecting Infant Care, involving 3,297 mothers.

Disclosures: The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health funded the study. The authors reported no financial disclosures.

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Zika linked to a spectrum of neuroinflammatory diseases

Understanding Zika-induced neurological diseases
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Fri, 01/18/2019 - 16:57

 

New evidence in support of a link between Zika virus infection and an increase in the incidence of neurological syndromes in adults has come from a prospective, observational study that demonstrates the presence of the infection in both serum and cerebrospinal fluid of patients with new-onset acute neuroinflammatory disease.

peliustok/Thinkstock
In the study cohort, 29 patients were diagnosed with GBS, 7 with encephalitis, 3 with transverse myelitis, and 1 with chronic inflammatory demyelinating polyneuropathy. These numbers indicate a fourfold increase in neurological syndrome diagnoses in adults, compared with a similar time frame during 2013-2014, before the Zika outbreak in Brazil, the investigators wrote.

Overall, it appears that Zika virus is associated with the trend for the rapid increase in hospital admissions for certain neurological syndromes, Dr. da Silva and his coauthors said. In addition, “we believe that our method of matching CSF and blood serologic findings offers a substantial aid to minimize [costs and] cross-reactivity in countries with a high prevalence of other concurrent flavivirosis.”

The study cohort was enrolled at a tertiary care, academic hospital in Rio de Janeiro. The median age was 44, and 15 were women. The study was limited by selection of neurological syndromes that have previously been associated with other flaviviruses, the short study period, and the use of patients from only one hospital.

Dr. da Silva reported no financial disclosures. One author reported receiving grants from Conselho Nacional de Desenvolvimento e Pesquisa and Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Other study authors reported no financial disclosures.

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The 2015 Zika outbreaks in the Americas were notable for the recognition that Zika virus could be associated with neurological conditions. It was found that the overall risk of congenital neurologic abnormalities in fetuses and liveborn children of mothers enrolled in the Centers for Disease Control and Prevention’s Zika Pregnancy Registry with definite laboratory evidence of Zika virus infection during pregnancy was approximately 17 times higher than the expected baseline rate in uninfected mothers. It wasn’t until later, however, that GBS became the first non–pregnancy-related neurological syndrome to be associate with Zika in adults.

It is critically important to understand both the spectrum and frequency of Zika virus–induced neurologic diseases. The article by Dr. da Silva and colleagues in this issue of JAMA Neurology represents an initial approach to this problem. During the reporting period, they found that 93% of the patients with GBS (27 of 29), 71% of the patients with encephalitis (5 of 7), 67% of the patients with transverse myelitis (2 of 3), and the single patient with chronic inflammatory demyelinating polyneuropathy showed evidence of recent Zika virus infection, indicating a link between neurological syndromes and Zika.

However, it should be noted that, because of factors including referral bias, a study such as this cannot determine exact frequencies of Zika virus infection among patients with the syndromes examined, but it may serve to help confirm that Zika can be associated with such syndromes.
 

Kenneth L. Tyler, MD, is the Louise Baum Endowed Professor and Chair of the department of neurology at the University of Colorado at Denver, Aurora. Karen L. Roos, MD, is the John and Nancy Professor of Neurology at the University of Indiana, Indianapolis. They published these comments in an editorial accompanying the da Silva et al. article in JAMA Neurology (2017 Aug 14. doi: 10.1001/jamaneurol.2017.1471). Neither author reported any financial disclosures.

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The 2015 Zika outbreaks in the Americas were notable for the recognition that Zika virus could be associated with neurological conditions. It was found that the overall risk of congenital neurologic abnormalities in fetuses and liveborn children of mothers enrolled in the Centers for Disease Control and Prevention’s Zika Pregnancy Registry with definite laboratory evidence of Zika virus infection during pregnancy was approximately 17 times higher than the expected baseline rate in uninfected mothers. It wasn’t until later, however, that GBS became the first non–pregnancy-related neurological syndrome to be associate with Zika in adults.

It is critically important to understand both the spectrum and frequency of Zika virus–induced neurologic diseases. The article by Dr. da Silva and colleagues in this issue of JAMA Neurology represents an initial approach to this problem. During the reporting period, they found that 93% of the patients with GBS (27 of 29), 71% of the patients with encephalitis (5 of 7), 67% of the patients with transverse myelitis (2 of 3), and the single patient with chronic inflammatory demyelinating polyneuropathy showed evidence of recent Zika virus infection, indicating a link between neurological syndromes and Zika.

However, it should be noted that, because of factors including referral bias, a study such as this cannot determine exact frequencies of Zika virus infection among patients with the syndromes examined, but it may serve to help confirm that Zika can be associated with such syndromes.
 

Kenneth L. Tyler, MD, is the Louise Baum Endowed Professor and Chair of the department of neurology at the University of Colorado at Denver, Aurora. Karen L. Roos, MD, is the John and Nancy Professor of Neurology at the University of Indiana, Indianapolis. They published these comments in an editorial accompanying the da Silva et al. article in JAMA Neurology (2017 Aug 14. doi: 10.1001/jamaneurol.2017.1471). Neither author reported any financial disclosures.

Body

 

The 2015 Zika outbreaks in the Americas were notable for the recognition that Zika virus could be associated with neurological conditions. It was found that the overall risk of congenital neurologic abnormalities in fetuses and liveborn children of mothers enrolled in the Centers for Disease Control and Prevention’s Zika Pregnancy Registry with definite laboratory evidence of Zika virus infection during pregnancy was approximately 17 times higher than the expected baseline rate in uninfected mothers. It wasn’t until later, however, that GBS became the first non–pregnancy-related neurological syndrome to be associate with Zika in adults.

It is critically important to understand both the spectrum and frequency of Zika virus–induced neurologic diseases. The article by Dr. da Silva and colleagues in this issue of JAMA Neurology represents an initial approach to this problem. During the reporting period, they found that 93% of the patients with GBS (27 of 29), 71% of the patients with encephalitis (5 of 7), 67% of the patients with transverse myelitis (2 of 3), and the single patient with chronic inflammatory demyelinating polyneuropathy showed evidence of recent Zika virus infection, indicating a link between neurological syndromes and Zika.

However, it should be noted that, because of factors including referral bias, a study such as this cannot determine exact frequencies of Zika virus infection among patients with the syndromes examined, but it may serve to help confirm that Zika can be associated with such syndromes.
 

Kenneth L. Tyler, MD, is the Louise Baum Endowed Professor and Chair of the department of neurology at the University of Colorado at Denver, Aurora. Karen L. Roos, MD, is the John and Nancy Professor of Neurology at the University of Indiana, Indianapolis. They published these comments in an editorial accompanying the da Silva et al. article in JAMA Neurology (2017 Aug 14. doi: 10.1001/jamaneurol.2017.1471). Neither author reported any financial disclosures.

Title
Understanding Zika-induced neurological diseases
Understanding Zika-induced neurological diseases

 

New evidence in support of a link between Zika virus infection and an increase in the incidence of neurological syndromes in adults has come from a prospective, observational study that demonstrates the presence of the infection in both serum and cerebrospinal fluid of patients with new-onset acute neuroinflammatory disease.

peliustok/Thinkstock
In the study cohort, 29 patients were diagnosed with GBS, 7 with encephalitis, 3 with transverse myelitis, and 1 with chronic inflammatory demyelinating polyneuropathy. These numbers indicate a fourfold increase in neurological syndrome diagnoses in adults, compared with a similar time frame during 2013-2014, before the Zika outbreak in Brazil, the investigators wrote.

Overall, it appears that Zika virus is associated with the trend for the rapid increase in hospital admissions for certain neurological syndromes, Dr. da Silva and his coauthors said. In addition, “we believe that our method of matching CSF and blood serologic findings offers a substantial aid to minimize [costs and] cross-reactivity in countries with a high prevalence of other concurrent flavivirosis.”

The study cohort was enrolled at a tertiary care, academic hospital in Rio de Janeiro. The median age was 44, and 15 were women. The study was limited by selection of neurological syndromes that have previously been associated with other flaviviruses, the short study period, and the use of patients from only one hospital.

Dr. da Silva reported no financial disclosures. One author reported receiving grants from Conselho Nacional de Desenvolvimento e Pesquisa and Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Other study authors reported no financial disclosures.

 

New evidence in support of a link between Zika virus infection and an increase in the incidence of neurological syndromes in adults has come from a prospective, observational study that demonstrates the presence of the infection in both serum and cerebrospinal fluid of patients with new-onset acute neuroinflammatory disease.

peliustok/Thinkstock
In the study cohort, 29 patients were diagnosed with GBS, 7 with encephalitis, 3 with transverse myelitis, and 1 with chronic inflammatory demyelinating polyneuropathy. These numbers indicate a fourfold increase in neurological syndrome diagnoses in adults, compared with a similar time frame during 2013-2014, before the Zika outbreak in Brazil, the investigators wrote.

Overall, it appears that Zika virus is associated with the trend for the rapid increase in hospital admissions for certain neurological syndromes, Dr. da Silva and his coauthors said. In addition, “we believe that our method of matching CSF and blood serologic findings offers a substantial aid to minimize [costs and] cross-reactivity in countries with a high prevalence of other concurrent flavivirosis.”

The study cohort was enrolled at a tertiary care, academic hospital in Rio de Janeiro. The median age was 44, and 15 were women. The study was limited by selection of neurological syndromes that have previously been associated with other flaviviruses, the short study period, and the use of patients from only one hospital.

Dr. da Silva reported no financial disclosures. One author reported receiving grants from Conselho Nacional de Desenvolvimento e Pesquisa and Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Other study authors reported no financial disclosures.

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Key clinical point: Increases in neurological syndromes in adults are associated with the Zika epidemic.

Major finding: Of 40 patients who were hospitalized for Guillain-Barré syndrome (GBS), meningoencephalitis, or transverse myelitis, 35 tested positive for Zika.

Data source: A prospective, observational cohort study of 40 patients who were admitted to a hospital in Brazil for a number of neurological conditions.

Disclosures: Dr. da Silva reported no financial disclosures. One author reported receiving grants from Conselho Nacional de Desenvolvimento e Pesquisa and Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro. Other study authors reported no financial disclosures.

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Inactivated flu vaccine more effective than live version

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Fri, 01/18/2019 - 16:57

 

The inactivated influenza vaccine is more effective than the quadrivalent live attenuated vaccine, according to a study conducted by the Influenza Vaccine Effectiveness Network.

After poor live vaccine performance in young children during the 2013-2014 flu season, the A(H1N1)pdm09 strain was changed. In response to earlier reports that the A(H1N1)pdm09 vaccine strain had poor thermostability, it was updated to A/Bolivia/559/2013 (an A/California/7/2009-like virus) for the 2015-2016 influenza season. Unfortunately, the changes did not increase the vaccine’s immunogenicity. At study sites in Michigan, Pennsylvania, Texas, Washington, and Wisconsin, 6,879 patients aged 6 months or older who presented for acute respiratory illness with a cough of 7 or fewer days were tested for influenza. Of those, 1,309 (19%) tested positive. Vaccination histories were taken from parent interviews and electronic health records.

young boy being vaccinated
Yarinca/Stockphoto
Vaccine effectiveness was estimated to be 48% in all age groups and for each virus subtype or lineage (95% confidence interval, 41-55; P less than .001); however, significant effectiveness was observed for only the inactivated influenza vaccine (P less than .001), compared with the quadrivalent live attenuated vaccine (P = .86), according to Michael L. Jackson, PhD, associate investigator at the Kaiser Permanente Washington Health Research Institute, and his coauthors. The 136 children who received the live vaccine were significantly more likely to contract influenza than the 682 children who received the inactivated vaccine (odds ratio, 2.7; 95% CI, 1.6-4.6; P less than .001), without any significant benefit over those who received no vaccine (live vaccine effectiveness, 5%; 95% CI, –47 to 39; P = .8). Looking specifically at children aged 2-17 years old, the risk of influenza was not significantly lower among those who received the quadrivalent live attenuated influenza vaccine than among those who received no vaccine; the inactivated vaccine had a marked benefit over no vaccine (vaccine effectiveness, 60%; 95% CI, 47-70; P less than .001).

“Although the quadrivalent live attenuated vaccine remains licensed in the United States, the [Advisory Committee on Immunization Practices] did not recommend this vaccine for the 2016-2017 influenza season,” the investigators wrote.

Partial funding for the research came from the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Jackson reported receiving a grant from Medimmune.

Read more in the New England Journal of Medicine (2017;377:534-43).
 

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The inactivated influenza vaccine is more effective than the quadrivalent live attenuated vaccine, according to a study conducted by the Influenza Vaccine Effectiveness Network.

After poor live vaccine performance in young children during the 2013-2014 flu season, the A(H1N1)pdm09 strain was changed. In response to earlier reports that the A(H1N1)pdm09 vaccine strain had poor thermostability, it was updated to A/Bolivia/559/2013 (an A/California/7/2009-like virus) for the 2015-2016 influenza season. Unfortunately, the changes did not increase the vaccine’s immunogenicity. At study sites in Michigan, Pennsylvania, Texas, Washington, and Wisconsin, 6,879 patients aged 6 months or older who presented for acute respiratory illness with a cough of 7 or fewer days were tested for influenza. Of those, 1,309 (19%) tested positive. Vaccination histories were taken from parent interviews and electronic health records.

young boy being vaccinated
Yarinca/Stockphoto
Vaccine effectiveness was estimated to be 48% in all age groups and for each virus subtype or lineage (95% confidence interval, 41-55; P less than .001); however, significant effectiveness was observed for only the inactivated influenza vaccine (P less than .001), compared with the quadrivalent live attenuated vaccine (P = .86), according to Michael L. Jackson, PhD, associate investigator at the Kaiser Permanente Washington Health Research Institute, and his coauthors. The 136 children who received the live vaccine were significantly more likely to contract influenza than the 682 children who received the inactivated vaccine (odds ratio, 2.7; 95% CI, 1.6-4.6; P less than .001), without any significant benefit over those who received no vaccine (live vaccine effectiveness, 5%; 95% CI, –47 to 39; P = .8). Looking specifically at children aged 2-17 years old, the risk of influenza was not significantly lower among those who received the quadrivalent live attenuated influenza vaccine than among those who received no vaccine; the inactivated vaccine had a marked benefit over no vaccine (vaccine effectiveness, 60%; 95% CI, 47-70; P less than .001).

“Although the quadrivalent live attenuated vaccine remains licensed in the United States, the [Advisory Committee on Immunization Practices] did not recommend this vaccine for the 2016-2017 influenza season,” the investigators wrote.

Partial funding for the research came from the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Jackson reported receiving a grant from Medimmune.

Read more in the New England Journal of Medicine (2017;377:534-43).
 

 

The inactivated influenza vaccine is more effective than the quadrivalent live attenuated vaccine, according to a study conducted by the Influenza Vaccine Effectiveness Network.

After poor live vaccine performance in young children during the 2013-2014 flu season, the A(H1N1)pdm09 strain was changed. In response to earlier reports that the A(H1N1)pdm09 vaccine strain had poor thermostability, it was updated to A/Bolivia/559/2013 (an A/California/7/2009-like virus) for the 2015-2016 influenza season. Unfortunately, the changes did not increase the vaccine’s immunogenicity. At study sites in Michigan, Pennsylvania, Texas, Washington, and Wisconsin, 6,879 patients aged 6 months or older who presented for acute respiratory illness with a cough of 7 or fewer days were tested for influenza. Of those, 1,309 (19%) tested positive. Vaccination histories were taken from parent interviews and electronic health records.

young boy being vaccinated
Yarinca/Stockphoto
Vaccine effectiveness was estimated to be 48% in all age groups and for each virus subtype or lineage (95% confidence interval, 41-55; P less than .001); however, significant effectiveness was observed for only the inactivated influenza vaccine (P less than .001), compared with the quadrivalent live attenuated vaccine (P = .86), according to Michael L. Jackson, PhD, associate investigator at the Kaiser Permanente Washington Health Research Institute, and his coauthors. The 136 children who received the live vaccine were significantly more likely to contract influenza than the 682 children who received the inactivated vaccine (odds ratio, 2.7; 95% CI, 1.6-4.6; P less than .001), without any significant benefit over those who received no vaccine (live vaccine effectiveness, 5%; 95% CI, –47 to 39; P = .8). Looking specifically at children aged 2-17 years old, the risk of influenza was not significantly lower among those who received the quadrivalent live attenuated influenza vaccine than among those who received no vaccine; the inactivated vaccine had a marked benefit over no vaccine (vaccine effectiveness, 60%; 95% CI, 47-70; P less than .001).

“Although the quadrivalent live attenuated vaccine remains licensed in the United States, the [Advisory Committee on Immunization Practices] did not recommend this vaccine for the 2016-2017 influenza season,” the investigators wrote.

Partial funding for the research came from the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Jackson reported receiving a grant from Medimmune.

Read more in the New England Journal of Medicine (2017;377:534-43).
 

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