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Antidepressants highly effective against binge-eating disorder
People with binge-eating disorder have the greatest chance of achieving normal eating habits and alleviating symptoms associated with the disorder by taking second-generation antidepressants, topiramate, and lisdexamfetamine and engaging in cognitive-behavioral therapy, an analysis of several studies showed.
The findings should be used to “address other treatments, combinations of treatments, and comparisons between treatments; treatment for postbariatric surgery patients and children; and the course of these illnesses,” according to the report, released as part of the Comparative Effectiveness Review No. 160 by the Agency for Healthcare Research and Quality.
The authors of the report examined a total of 52 randomized controlled trials and 15 observational studies collected through searches of MEDLINE, EMBASE, the Cochrane Library, Academic OneFile, and the Cumulative Index to Nursing and Allied Health Literature databases, with 48 of the included studies specifically concerning binge-eating disorder (BED). English-language studies up through Jan. 19, 2015, were included for analysis, and the investigators specifically looked for studies of individuals who met DSM-IV or DSM-5 criteria for BED and studies of postbariatric surgery patients, including children, experiencing loss-of-control (LOC) eating habits.
Each study was evaluated based on a set of 15 “key questions” to determine the effectiveness and harms of the treatments involved. The key questions used by the investigators sought to determine the evidence of effectiveness and harms of BED treatments; LOC eating among bariatric surgery patients; and the effectiveness of any LOC treatments based on age, sex, race, ethnicity, initial body mass index, duration of illness, and coexisting conditions. In addition, similar questions were used to ascertain the effectiveness of treatments on pediatric patients.
“Broadly, we included pharmacological, psychological, behavioral, and combination interventions,” the report stated. “We considered physical and psychological health outcomes in four major categories: binge behavior (binge eating or LOC eating); binge-eating–related psychopathology (e.g., weight and shape concerns, dietary restraint); physical health functioning (i.e., weight and other indexes of metabolic health, e.g., diabetes); and general psychopathology (e.g., depression, anxiety).”
Antidepressants were found to be more effective than placebos across the studies included in the survey, specifically second-generation antidepressants, and were 1.67 times more likely to help BED patients achieve abstinence than placebos used in these trials; 41% of subjects receiving antidepressants ultimately achieved abstinence, compared with 23% on placebos.
With topiramate, binge eating generally decreased to as little as one episode per week, and a higher portion of subjects (58%) achieved abstinence than those on placebo (28%). In addition, topiramate was found to decrease “obsessive thoughts and compulsions related to binge eating” by nearly 30%, versus 23% in subjects taking placebos.
Studies involving lisdexamfetamine showed abstinence achieved in 40% of subjects, far higher than the 15% on placebos, and a likelihood of achieving abstinence 2.61 times higher than for those in the placebo cohorts. Binge-eating episodes per week also decreased, and were, on average, anywhere from 1.7 to 1.3 fewer than those in subjects taking placebo. Subjects receiving cognitive-behavioral therapy – whether led by a therapist or self-led, though the former was found to have stronger evidence of effectiveness than the latter – had an average of 2.3 fewer binge-eating episodes per week, and subjects involved with therapy were 4.95 times more likely to achieve abstinence than those who were not receiving therapy.
“Findings about BED treatment interventions are likely to be applicable to all adults age 18 and older with the disorder, but chiefly to overweight or obese women,” the report stated. “We cannot comment on the applicability of treatment findings for specific subgroups of adults (even among women) or whether findings extend to BED patients diagnosed based on DSM-5 criteria.”
The authors also noted that the findings are unclear with respect to adolescents with BED or members of ethnic groups, and children with loss-of-control eating or who have undergone bariatric surgery.
“A convention for reporting and analyzing” outcomes is necessary for the findings of this study to take on real-world applications that can be beneficial to clinicians and their patients in the near future, the authors concluded. However, more multisite randomized, controlled trials are needed.
People with binge-eating disorder have the greatest chance of achieving normal eating habits and alleviating symptoms associated with the disorder by taking second-generation antidepressants, topiramate, and lisdexamfetamine and engaging in cognitive-behavioral therapy, an analysis of several studies showed.
The findings should be used to “address other treatments, combinations of treatments, and comparisons between treatments; treatment for postbariatric surgery patients and children; and the course of these illnesses,” according to the report, released as part of the Comparative Effectiveness Review No. 160 by the Agency for Healthcare Research and Quality.
The authors of the report examined a total of 52 randomized controlled trials and 15 observational studies collected through searches of MEDLINE, EMBASE, the Cochrane Library, Academic OneFile, and the Cumulative Index to Nursing and Allied Health Literature databases, with 48 of the included studies specifically concerning binge-eating disorder (BED). English-language studies up through Jan. 19, 2015, were included for analysis, and the investigators specifically looked for studies of individuals who met DSM-IV or DSM-5 criteria for BED and studies of postbariatric surgery patients, including children, experiencing loss-of-control (LOC) eating habits.
Each study was evaluated based on a set of 15 “key questions” to determine the effectiveness and harms of the treatments involved. The key questions used by the investigators sought to determine the evidence of effectiveness and harms of BED treatments; LOC eating among bariatric surgery patients; and the effectiveness of any LOC treatments based on age, sex, race, ethnicity, initial body mass index, duration of illness, and coexisting conditions. In addition, similar questions were used to ascertain the effectiveness of treatments on pediatric patients.
“Broadly, we included pharmacological, psychological, behavioral, and combination interventions,” the report stated. “We considered physical and psychological health outcomes in four major categories: binge behavior (binge eating or LOC eating); binge-eating–related psychopathology (e.g., weight and shape concerns, dietary restraint); physical health functioning (i.e., weight and other indexes of metabolic health, e.g., diabetes); and general psychopathology (e.g., depression, anxiety).”
Antidepressants were found to be more effective than placebos across the studies included in the survey, specifically second-generation antidepressants, and were 1.67 times more likely to help BED patients achieve abstinence than placebos used in these trials; 41% of subjects receiving antidepressants ultimately achieved abstinence, compared with 23% on placebos.
With topiramate, binge eating generally decreased to as little as one episode per week, and a higher portion of subjects (58%) achieved abstinence than those on placebo (28%). In addition, topiramate was found to decrease “obsessive thoughts and compulsions related to binge eating” by nearly 30%, versus 23% in subjects taking placebos.
Studies involving lisdexamfetamine showed abstinence achieved in 40% of subjects, far higher than the 15% on placebos, and a likelihood of achieving abstinence 2.61 times higher than for those in the placebo cohorts. Binge-eating episodes per week also decreased, and were, on average, anywhere from 1.7 to 1.3 fewer than those in subjects taking placebo. Subjects receiving cognitive-behavioral therapy – whether led by a therapist or self-led, though the former was found to have stronger evidence of effectiveness than the latter – had an average of 2.3 fewer binge-eating episodes per week, and subjects involved with therapy were 4.95 times more likely to achieve abstinence than those who were not receiving therapy.
“Findings about BED treatment interventions are likely to be applicable to all adults age 18 and older with the disorder, but chiefly to overweight or obese women,” the report stated. “We cannot comment on the applicability of treatment findings for specific subgroups of adults (even among women) or whether findings extend to BED patients diagnosed based on DSM-5 criteria.”
The authors also noted that the findings are unclear with respect to adolescents with BED or members of ethnic groups, and children with loss-of-control eating or who have undergone bariatric surgery.
“A convention for reporting and analyzing” outcomes is necessary for the findings of this study to take on real-world applications that can be beneficial to clinicians and their patients in the near future, the authors concluded. However, more multisite randomized, controlled trials are needed.
People with binge-eating disorder have the greatest chance of achieving normal eating habits and alleviating symptoms associated with the disorder by taking second-generation antidepressants, topiramate, and lisdexamfetamine and engaging in cognitive-behavioral therapy, an analysis of several studies showed.
The findings should be used to “address other treatments, combinations of treatments, and comparisons between treatments; treatment for postbariatric surgery patients and children; and the course of these illnesses,” according to the report, released as part of the Comparative Effectiveness Review No. 160 by the Agency for Healthcare Research and Quality.
The authors of the report examined a total of 52 randomized controlled trials and 15 observational studies collected through searches of MEDLINE, EMBASE, the Cochrane Library, Academic OneFile, and the Cumulative Index to Nursing and Allied Health Literature databases, with 48 of the included studies specifically concerning binge-eating disorder (BED). English-language studies up through Jan. 19, 2015, were included for analysis, and the investigators specifically looked for studies of individuals who met DSM-IV or DSM-5 criteria for BED and studies of postbariatric surgery patients, including children, experiencing loss-of-control (LOC) eating habits.
Each study was evaluated based on a set of 15 “key questions” to determine the effectiveness and harms of the treatments involved. The key questions used by the investigators sought to determine the evidence of effectiveness and harms of BED treatments; LOC eating among bariatric surgery patients; and the effectiveness of any LOC treatments based on age, sex, race, ethnicity, initial body mass index, duration of illness, and coexisting conditions. In addition, similar questions were used to ascertain the effectiveness of treatments on pediatric patients.
“Broadly, we included pharmacological, psychological, behavioral, and combination interventions,” the report stated. “We considered physical and psychological health outcomes in four major categories: binge behavior (binge eating or LOC eating); binge-eating–related psychopathology (e.g., weight and shape concerns, dietary restraint); physical health functioning (i.e., weight and other indexes of metabolic health, e.g., diabetes); and general psychopathology (e.g., depression, anxiety).”
Antidepressants were found to be more effective than placebos across the studies included in the survey, specifically second-generation antidepressants, and were 1.67 times more likely to help BED patients achieve abstinence than placebos used in these trials; 41% of subjects receiving antidepressants ultimately achieved abstinence, compared with 23% on placebos.
With topiramate, binge eating generally decreased to as little as one episode per week, and a higher portion of subjects (58%) achieved abstinence than those on placebo (28%). In addition, topiramate was found to decrease “obsessive thoughts and compulsions related to binge eating” by nearly 30%, versus 23% in subjects taking placebos.
Studies involving lisdexamfetamine showed abstinence achieved in 40% of subjects, far higher than the 15% on placebos, and a likelihood of achieving abstinence 2.61 times higher than for those in the placebo cohorts. Binge-eating episodes per week also decreased, and were, on average, anywhere from 1.7 to 1.3 fewer than those in subjects taking placebo. Subjects receiving cognitive-behavioral therapy – whether led by a therapist or self-led, though the former was found to have stronger evidence of effectiveness than the latter – had an average of 2.3 fewer binge-eating episodes per week, and subjects involved with therapy were 4.95 times more likely to achieve abstinence than those who were not receiving therapy.
“Findings about BED treatment interventions are likely to be applicable to all adults age 18 and older with the disorder, but chiefly to overweight or obese women,” the report stated. “We cannot comment on the applicability of treatment findings for specific subgroups of adults (even among women) or whether findings extend to BED patients diagnosed based on DSM-5 criteria.”
The authors also noted that the findings are unclear with respect to adolescents with BED or members of ethnic groups, and children with loss-of-control eating or who have undergone bariatric surgery.
“A convention for reporting and analyzing” outcomes is necessary for the findings of this study to take on real-world applications that can be beneficial to clinicians and their patients in the near future, the authors concluded. However, more multisite randomized, controlled trials are needed.
ACC, AHA update performance measures for lipid management
Updated performance measures regarding lipid management for secondary prevention, introducing and placing great emphasis on shared decision making between clinicians and patients, have been released jointly by the American College of Cardiology and the American Heart Association.
“These measures respect the wishes of patients regarding the use of statins and do not penalize physicians who may have a patient decline to take the medications for personal reasons,” Dr. Joseph P. Drozda Jr., chair of the update’s writing committee, said in a statement accompanying the release.
“Integrating patient values, preferences, and personal context with evidence-based medicine and guidelines is novel and changes the focus from recommending and prescribing statins ... to promoting choice by an informed patient,” said Dr. Drozda, director of outcomes research at Mercy Health, St. Louis.
Performance measures are intended to accelerate the translation of scientific evidence into clinical practice, and they are rapidly updated whenever there are changes to a relevant ACC/AHA guideline. In this case, lipid management performance measures needed updating because of new recommendations in the most recent ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-45). The new recommendations emphasized treatment with high-intensity statin therapy instead of achieving LDL-cholesterol targets.
In accordance with that, the lipid performance measures have been revised in four areas of lipid management: in secondary prevention for patients who have peripheral artery disease, STEMI or non-STEMI myocardial infarction, percutaneous coronary intervention, and coronary artery disease/hypertension. In addition, a new performance measure has been added addressing clinical atherosclerotic cardiovascular disease.
Abundant research has shown that only a fraction of patients with peripheral artery disease, MI, percutaneous coronary intervention, and coronary artery disease/hypertension who would benefit greatly from statin therapy are actually taking it, and that those who do take statins generally are receiving suboptimal doses. Studies also have clearly demonstrated that more intensive statin regimens reduce adverse cardiovascular events even further in these patient populations, Dr. Drozda and his associates said (J Am Coll Cardiol. 2015 Dec 13 [doi:10.1016/j.jacc.2015.02.003]).
“Better patient outcomes are realized only if patients agree with, act on, and adhere to [statin recommendations] for 5-10 years.” At present, up to half of patients prescribed statins for secondary prevention discontinue the drugs within 1-2 years, they noted.
“Clinicians need to embrace the concept that evidence-based medicine and guidelines alone are not sufficient to make a [treatment] recommendation or a decision; rather, the evidence has to be considered from the viewpoint of what matters to individual patients. Hence, the clinical encounter transforms from one where the clinician strives to convince the patient of the ‘right answer’ to one where the clinician and patient collaborate, deliberate, and arrive at the ‘best answer’ that fits patient preferences, values, and context,” Dr. Drozda and his associates said.
Clinicians may not be aware of all the factors contributing to statin discontinuation and missed doses. The cost of the drug or the copay amount may be unaffordable. The label instructions may be unclear. The patient may be too forgetful to take medications reliably, or too embarrassed to discuss the agent’s adverse effects. The patient may dislike having to take any medication, or may not understand its importance when he or she has no symptoms. One strategy to address all possible reasons for nonadherence and to accomplish shared decision making is for the clinician at every office visit to review the medication list; ask about adverse effects, cost, and adherence; and discuss barriers to adherence, the investigators said.
The updated lipid performance measures are available at www.acc.org and www.my.americanheart.org.
This work was supported exclusively by the ACC and the AHA. The financial disclosures of Dr. Drozda and the other members of the writing committee are available from the ACC and the AHA.
Updated performance measures regarding lipid management for secondary prevention, introducing and placing great emphasis on shared decision making between clinicians and patients, have been released jointly by the American College of Cardiology and the American Heart Association.
“These measures respect the wishes of patients regarding the use of statins and do not penalize physicians who may have a patient decline to take the medications for personal reasons,” Dr. Joseph P. Drozda Jr., chair of the update’s writing committee, said in a statement accompanying the release.
“Integrating patient values, preferences, and personal context with evidence-based medicine and guidelines is novel and changes the focus from recommending and prescribing statins ... to promoting choice by an informed patient,” said Dr. Drozda, director of outcomes research at Mercy Health, St. Louis.
Performance measures are intended to accelerate the translation of scientific evidence into clinical practice, and they are rapidly updated whenever there are changes to a relevant ACC/AHA guideline. In this case, lipid management performance measures needed updating because of new recommendations in the most recent ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-45). The new recommendations emphasized treatment with high-intensity statin therapy instead of achieving LDL-cholesterol targets.
In accordance with that, the lipid performance measures have been revised in four areas of lipid management: in secondary prevention for patients who have peripheral artery disease, STEMI or non-STEMI myocardial infarction, percutaneous coronary intervention, and coronary artery disease/hypertension. In addition, a new performance measure has been added addressing clinical atherosclerotic cardiovascular disease.
Abundant research has shown that only a fraction of patients with peripheral artery disease, MI, percutaneous coronary intervention, and coronary artery disease/hypertension who would benefit greatly from statin therapy are actually taking it, and that those who do take statins generally are receiving suboptimal doses. Studies also have clearly demonstrated that more intensive statin regimens reduce adverse cardiovascular events even further in these patient populations, Dr. Drozda and his associates said (J Am Coll Cardiol. 2015 Dec 13 [doi:10.1016/j.jacc.2015.02.003]).
“Better patient outcomes are realized only if patients agree with, act on, and adhere to [statin recommendations] for 5-10 years.” At present, up to half of patients prescribed statins for secondary prevention discontinue the drugs within 1-2 years, they noted.
“Clinicians need to embrace the concept that evidence-based medicine and guidelines alone are not sufficient to make a [treatment] recommendation or a decision; rather, the evidence has to be considered from the viewpoint of what matters to individual patients. Hence, the clinical encounter transforms from one where the clinician strives to convince the patient of the ‘right answer’ to one where the clinician and patient collaborate, deliberate, and arrive at the ‘best answer’ that fits patient preferences, values, and context,” Dr. Drozda and his associates said.
Clinicians may not be aware of all the factors contributing to statin discontinuation and missed doses. The cost of the drug or the copay amount may be unaffordable. The label instructions may be unclear. The patient may be too forgetful to take medications reliably, or too embarrassed to discuss the agent’s adverse effects. The patient may dislike having to take any medication, or may not understand its importance when he or she has no symptoms. One strategy to address all possible reasons for nonadherence and to accomplish shared decision making is for the clinician at every office visit to review the medication list; ask about adverse effects, cost, and adherence; and discuss barriers to adherence, the investigators said.
The updated lipid performance measures are available at www.acc.org and www.my.americanheart.org.
This work was supported exclusively by the ACC and the AHA. The financial disclosures of Dr. Drozda and the other members of the writing committee are available from the ACC and the AHA.
Updated performance measures regarding lipid management for secondary prevention, introducing and placing great emphasis on shared decision making between clinicians and patients, have been released jointly by the American College of Cardiology and the American Heart Association.
“These measures respect the wishes of patients regarding the use of statins and do not penalize physicians who may have a patient decline to take the medications for personal reasons,” Dr. Joseph P. Drozda Jr., chair of the update’s writing committee, said in a statement accompanying the release.
“Integrating patient values, preferences, and personal context with evidence-based medicine and guidelines is novel and changes the focus from recommending and prescribing statins ... to promoting choice by an informed patient,” said Dr. Drozda, director of outcomes research at Mercy Health, St. Louis.
Performance measures are intended to accelerate the translation of scientific evidence into clinical practice, and they are rapidly updated whenever there are changes to a relevant ACC/AHA guideline. In this case, lipid management performance measures needed updating because of new recommendations in the most recent ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-45). The new recommendations emphasized treatment with high-intensity statin therapy instead of achieving LDL-cholesterol targets.
In accordance with that, the lipid performance measures have been revised in four areas of lipid management: in secondary prevention for patients who have peripheral artery disease, STEMI or non-STEMI myocardial infarction, percutaneous coronary intervention, and coronary artery disease/hypertension. In addition, a new performance measure has been added addressing clinical atherosclerotic cardiovascular disease.
Abundant research has shown that only a fraction of patients with peripheral artery disease, MI, percutaneous coronary intervention, and coronary artery disease/hypertension who would benefit greatly from statin therapy are actually taking it, and that those who do take statins generally are receiving suboptimal doses. Studies also have clearly demonstrated that more intensive statin regimens reduce adverse cardiovascular events even further in these patient populations, Dr. Drozda and his associates said (J Am Coll Cardiol. 2015 Dec 13 [doi:10.1016/j.jacc.2015.02.003]).
“Better patient outcomes are realized only if patients agree with, act on, and adhere to [statin recommendations] for 5-10 years.” At present, up to half of patients prescribed statins for secondary prevention discontinue the drugs within 1-2 years, they noted.
“Clinicians need to embrace the concept that evidence-based medicine and guidelines alone are not sufficient to make a [treatment] recommendation or a decision; rather, the evidence has to be considered from the viewpoint of what matters to individual patients. Hence, the clinical encounter transforms from one where the clinician strives to convince the patient of the ‘right answer’ to one where the clinician and patient collaborate, deliberate, and arrive at the ‘best answer’ that fits patient preferences, values, and context,” Dr. Drozda and his associates said.
Clinicians may not be aware of all the factors contributing to statin discontinuation and missed doses. The cost of the drug or the copay amount may be unaffordable. The label instructions may be unclear. The patient may be too forgetful to take medications reliably, or too embarrassed to discuss the agent’s adverse effects. The patient may dislike having to take any medication, or may not understand its importance when he or she has no symptoms. One strategy to address all possible reasons for nonadherence and to accomplish shared decision making is for the clinician at every office visit to review the medication list; ask about adverse effects, cost, and adherence; and discuss barriers to adherence, the investigators said.
The updated lipid performance measures are available at www.acc.org and www.my.americanheart.org.
This work was supported exclusively by the ACC and the AHA. The financial disclosures of Dr. Drozda and the other members of the writing committee are available from the ACC and the AHA.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Patients with high cholesterol refrain from medicating
At a time when more than a third of the U.S. population fell under the umbrella of taking or being eligible to take cholesterol-lowering medication, many of the adults in such a category made no attempt to improve their health, according to the Centers for Disease Control and Prevention’s analysis of data from the 2005-2012 National Health and Nutrition Examination surveys.
The researchers assessed as a group adults who met criteria in the 2013 American College of Cardiology/American Heart Association cholesterol management guidelines, as well as those currently taking cholesterol-lowering medication. At the time of the survey, 78.1 million (36.7%) of the U.S. population aged 21 and over had taken or were eligible for cholesterol-lowering treatments, the investigators noted.
Among those who were on, or were eligible for taking, cholesterol-lowering medication, 55.5% said they were taking their drugs, 46.6% reported having made lifestyle modifications such as exercising and adopting a heart-healthy diet, and 37.1 % reported making lifestyle modifications and taking cholesterol-lowing medications. Although many Americans with high cholesterol levels made efforts to decrease their cholesterol levels, the researchers noted that 35.5% of the adults who needed or used cholesterol-lowering drugs neither took the medicine nor implemented appropriate lifestyle changes.
There were significant differences in the proportion of men (52.9%) and women (58.6%) taking cholesterol drugs (P = .010), as well as among racial/ethnic groups (whites, 58.0%; Mexican-Americans, 47.1%; and blacks, 46.0%; P less than .001).
“This report is one of the first to examine sex and racial/ethnic differences in medication use in a nationally representative sample of adults who are eligible for treatment,” wrote Carla Mercado, Ph.D., of the CDC and her colleagues.
The researchers recommended that stakeholders “implement evidence-based interventions from the Guide to Community Preventive Services to improve screening and management of cholesterol.”
Read the article in MMWR (2015 Dec 4;64[47]:1305-11. doi: 10.15585/mmwr.mm6447a1).
At a time when more than a third of the U.S. population fell under the umbrella of taking or being eligible to take cholesterol-lowering medication, many of the adults in such a category made no attempt to improve their health, according to the Centers for Disease Control and Prevention’s analysis of data from the 2005-2012 National Health and Nutrition Examination surveys.
The researchers assessed as a group adults who met criteria in the 2013 American College of Cardiology/American Heart Association cholesterol management guidelines, as well as those currently taking cholesterol-lowering medication. At the time of the survey, 78.1 million (36.7%) of the U.S. population aged 21 and over had taken or were eligible for cholesterol-lowering treatments, the investigators noted.
Among those who were on, or were eligible for taking, cholesterol-lowering medication, 55.5% said they were taking their drugs, 46.6% reported having made lifestyle modifications such as exercising and adopting a heart-healthy diet, and 37.1 % reported making lifestyle modifications and taking cholesterol-lowing medications. Although many Americans with high cholesterol levels made efforts to decrease their cholesterol levels, the researchers noted that 35.5% of the adults who needed or used cholesterol-lowering drugs neither took the medicine nor implemented appropriate lifestyle changes.
There were significant differences in the proportion of men (52.9%) and women (58.6%) taking cholesterol drugs (P = .010), as well as among racial/ethnic groups (whites, 58.0%; Mexican-Americans, 47.1%; and blacks, 46.0%; P less than .001).
“This report is one of the first to examine sex and racial/ethnic differences in medication use in a nationally representative sample of adults who are eligible for treatment,” wrote Carla Mercado, Ph.D., of the CDC and her colleagues.
The researchers recommended that stakeholders “implement evidence-based interventions from the Guide to Community Preventive Services to improve screening and management of cholesterol.”
Read the article in MMWR (2015 Dec 4;64[47]:1305-11. doi: 10.15585/mmwr.mm6447a1).
At a time when more than a third of the U.S. population fell under the umbrella of taking or being eligible to take cholesterol-lowering medication, many of the adults in such a category made no attempt to improve their health, according to the Centers for Disease Control and Prevention’s analysis of data from the 2005-2012 National Health and Nutrition Examination surveys.
The researchers assessed as a group adults who met criteria in the 2013 American College of Cardiology/American Heart Association cholesterol management guidelines, as well as those currently taking cholesterol-lowering medication. At the time of the survey, 78.1 million (36.7%) of the U.S. population aged 21 and over had taken or were eligible for cholesterol-lowering treatments, the investigators noted.
Among those who were on, or were eligible for taking, cholesterol-lowering medication, 55.5% said they were taking their drugs, 46.6% reported having made lifestyle modifications such as exercising and adopting a heart-healthy diet, and 37.1 % reported making lifestyle modifications and taking cholesterol-lowing medications. Although many Americans with high cholesterol levels made efforts to decrease their cholesterol levels, the researchers noted that 35.5% of the adults who needed or used cholesterol-lowering drugs neither took the medicine nor implemented appropriate lifestyle changes.
There were significant differences in the proportion of men (52.9%) and women (58.6%) taking cholesterol drugs (P = .010), as well as among racial/ethnic groups (whites, 58.0%; Mexican-Americans, 47.1%; and blacks, 46.0%; P less than .001).
“This report is one of the first to examine sex and racial/ethnic differences in medication use in a nationally representative sample of adults who are eligible for treatment,” wrote Carla Mercado, Ph.D., of the CDC and her colleagues.
The researchers recommended that stakeholders “implement evidence-based interventions from the Guide to Community Preventive Services to improve screening and management of cholesterol.”
Read the article in MMWR (2015 Dec 4;64[47]:1305-11. doi: 10.15585/mmwr.mm6447a1).
FROM MMWR
Comparing once-weekly GLP-1RAs
When compared head-to-head in patients with type 2 diabetes mellitus, five once-weekly glucagonlike peptide–1 receptor agonists yield appreciably different effects on hemoglonin A1c (HbA1c) fasting plasma glucose, body weight, and nausea but very similar effects on hypoglycemia, blood pressure, lipids, and C-reactive protein levels, according to a report published online Dec. 7 in Annals of Internal Medicine.
Until now, no studies have directly compared the efficacy and safety of various glucagonlike peptide–1 receptor agonists (GLP-1RAs) for patients with type 2 diabetes. To do so, researchers performed a network meta-analysis of 34 randomized controlled trials of at least 6 months’ duration involving a total of 21,126 patients and comparing albiglutide, dulaglutide, exenatide, semaglutide, or taspoglutide against either placebo or another glucose-lowering agent. All the trials were published between 2008 and 2015, said Dr. Francesco Zaccardi of the Diabetes Research Centre, Leicester (England) General Hospital and his associates.
Taken together, the five once-weekly GLP-1RAs reduced the primary outcome measure, hemoglobin A1c, compared with placebo. Dulaglutide produced the greatest reduction (1.4%). All the agents also significantly reduced fasting plasma glucose, compared with placebo, with exenatide producing the greatest reduction. Exenatide, semaglutide, and higher doses of dulaglutide and taspoglutide also significantly reduced body weight by between 0.7 kg and 1.3 kg, compared with placebo. “Our results would therefore suggest clinically significant differences on three key indicators of metabolic control,” Dr. Zaccardi and his associates said (Ann. Intern. Med. 2015 Dec. 7. doi: 10.7326/M15-1432).
The risk for nausea also differed among the five agents. Taspoglutide carried the highest risk, which ranged from two- to ninefold higher than that of the other GLP-1RAs. With taspoglutide the risk for nausea was more than eight times higher than that with albiglutide.
Conversely, the risks for symptomatic hypoglycemia and rates of beneficial changes in blood pressure, lipid profiles, and C-reactive protein levels were similar across the five GLP-1RAs.
This meta-analysis was supported by an unrestricted grant from Sanofi-Aventis to the University of Leicester, and by the National Institute for Health Research and University Hospitals of Leicester and Loughborough University. Dr. Zaccardi reported having no relevant financial disclosures other than funding from Sanofi-Aventis; his associates reported ties to numerous industry sources, including the manufacturers of the five GLP-1RAs analyzed here.
Be skeptical of any claims that the 5 GLP-1RAs assessed by Zaccardi et al. differ in efficacy or safety measures, because of the low quality of the evidence summarized in this network meta-analysis.
The trials that were reviewed had inadequate blinding and substantial loss to follow-up, and data on outcomes that are most important to patients—quality of life, treatment burden, morbidity, and mortality – were sparse or nonexistent. The trials were primarily designed and reported by the manufacturers, whose goal is to enter the drug market and position their product favorably, not to facilitate clinical decision making. That’s why reliable head-to-head comparison studies of agents made by competitors are so rare, and why researchers have to rely on questionable strategies like pooling data from studies with very different patient populations and methodologies.
Perhaps the top priority in the effort to find the antihyperglycemic agent that best addresses a patient’s situation should be finding the best drug class. Tools are available to facilitate this task (Arch Intern Med. 2009;169:1560-8. doi: 10.1001/archinternmed.2009.293).
Dr. Victor M. Montori is in the Knowledge and Evaluation Research Unit in the divisions of endocrinology, diabetes, metabolism, and nutrition research at the Mayo Clinic in Rochester, Minn. His financial disclosures are available at www.annals.orgDr. Montori made these remarks in an editorial accompanying Dr. Zaccardi’s report (Ann. Intern. Med. 2015 Dec. 7. doi: 10.7326/M15-2610).
Be skeptical of any claims that the 5 GLP-1RAs assessed by Zaccardi et al. differ in efficacy or safety measures, because of the low quality of the evidence summarized in this network meta-analysis.
The trials that were reviewed had inadequate blinding and substantial loss to follow-up, and data on outcomes that are most important to patients—quality of life, treatment burden, morbidity, and mortality – were sparse or nonexistent. The trials were primarily designed and reported by the manufacturers, whose goal is to enter the drug market and position their product favorably, not to facilitate clinical decision making. That’s why reliable head-to-head comparison studies of agents made by competitors are so rare, and why researchers have to rely on questionable strategies like pooling data from studies with very different patient populations and methodologies.
Perhaps the top priority in the effort to find the antihyperglycemic agent that best addresses a patient’s situation should be finding the best drug class. Tools are available to facilitate this task (Arch Intern Med. 2009;169:1560-8. doi: 10.1001/archinternmed.2009.293).
Dr. Victor M. Montori is in the Knowledge and Evaluation Research Unit in the divisions of endocrinology, diabetes, metabolism, and nutrition research at the Mayo Clinic in Rochester, Minn. His financial disclosures are available at www.annals.orgDr. Montori made these remarks in an editorial accompanying Dr. Zaccardi’s report (Ann. Intern. Med. 2015 Dec. 7. doi: 10.7326/M15-2610).
Be skeptical of any claims that the 5 GLP-1RAs assessed by Zaccardi et al. differ in efficacy or safety measures, because of the low quality of the evidence summarized in this network meta-analysis.
The trials that were reviewed had inadequate blinding and substantial loss to follow-up, and data on outcomes that are most important to patients—quality of life, treatment burden, morbidity, and mortality – were sparse or nonexistent. The trials were primarily designed and reported by the manufacturers, whose goal is to enter the drug market and position their product favorably, not to facilitate clinical decision making. That’s why reliable head-to-head comparison studies of agents made by competitors are so rare, and why researchers have to rely on questionable strategies like pooling data from studies with very different patient populations and methodologies.
Perhaps the top priority in the effort to find the antihyperglycemic agent that best addresses a patient’s situation should be finding the best drug class. Tools are available to facilitate this task (Arch Intern Med. 2009;169:1560-8. doi: 10.1001/archinternmed.2009.293).
Dr. Victor M. Montori is in the Knowledge and Evaluation Research Unit in the divisions of endocrinology, diabetes, metabolism, and nutrition research at the Mayo Clinic in Rochester, Minn. His financial disclosures are available at www.annals.orgDr. Montori made these remarks in an editorial accompanying Dr. Zaccardi’s report (Ann. Intern. Med. 2015 Dec. 7. doi: 10.7326/M15-2610).
When compared head-to-head in patients with type 2 diabetes mellitus, five once-weekly glucagonlike peptide–1 receptor agonists yield appreciably different effects on hemoglonin A1c (HbA1c) fasting plasma glucose, body weight, and nausea but very similar effects on hypoglycemia, blood pressure, lipids, and C-reactive protein levels, according to a report published online Dec. 7 in Annals of Internal Medicine.
Until now, no studies have directly compared the efficacy and safety of various glucagonlike peptide–1 receptor agonists (GLP-1RAs) for patients with type 2 diabetes. To do so, researchers performed a network meta-analysis of 34 randomized controlled trials of at least 6 months’ duration involving a total of 21,126 patients and comparing albiglutide, dulaglutide, exenatide, semaglutide, or taspoglutide against either placebo or another glucose-lowering agent. All the trials were published between 2008 and 2015, said Dr. Francesco Zaccardi of the Diabetes Research Centre, Leicester (England) General Hospital and his associates.
Taken together, the five once-weekly GLP-1RAs reduced the primary outcome measure, hemoglobin A1c, compared with placebo. Dulaglutide produced the greatest reduction (1.4%). All the agents also significantly reduced fasting plasma glucose, compared with placebo, with exenatide producing the greatest reduction. Exenatide, semaglutide, and higher doses of dulaglutide and taspoglutide also significantly reduced body weight by between 0.7 kg and 1.3 kg, compared with placebo. “Our results would therefore suggest clinically significant differences on three key indicators of metabolic control,” Dr. Zaccardi and his associates said (Ann. Intern. Med. 2015 Dec. 7. doi: 10.7326/M15-1432).
The risk for nausea also differed among the five agents. Taspoglutide carried the highest risk, which ranged from two- to ninefold higher than that of the other GLP-1RAs. With taspoglutide the risk for nausea was more than eight times higher than that with albiglutide.
Conversely, the risks for symptomatic hypoglycemia and rates of beneficial changes in blood pressure, lipid profiles, and C-reactive protein levels were similar across the five GLP-1RAs.
This meta-analysis was supported by an unrestricted grant from Sanofi-Aventis to the University of Leicester, and by the National Institute for Health Research and University Hospitals of Leicester and Loughborough University. Dr. Zaccardi reported having no relevant financial disclosures other than funding from Sanofi-Aventis; his associates reported ties to numerous industry sources, including the manufacturers of the five GLP-1RAs analyzed here.
When compared head-to-head in patients with type 2 diabetes mellitus, five once-weekly glucagonlike peptide–1 receptor agonists yield appreciably different effects on hemoglonin A1c (HbA1c) fasting plasma glucose, body weight, and nausea but very similar effects on hypoglycemia, blood pressure, lipids, and C-reactive protein levels, according to a report published online Dec. 7 in Annals of Internal Medicine.
Until now, no studies have directly compared the efficacy and safety of various glucagonlike peptide–1 receptor agonists (GLP-1RAs) for patients with type 2 diabetes. To do so, researchers performed a network meta-analysis of 34 randomized controlled trials of at least 6 months’ duration involving a total of 21,126 patients and comparing albiglutide, dulaglutide, exenatide, semaglutide, or taspoglutide against either placebo or another glucose-lowering agent. All the trials were published between 2008 and 2015, said Dr. Francesco Zaccardi of the Diabetes Research Centre, Leicester (England) General Hospital and his associates.
Taken together, the five once-weekly GLP-1RAs reduced the primary outcome measure, hemoglobin A1c, compared with placebo. Dulaglutide produced the greatest reduction (1.4%). All the agents also significantly reduced fasting plasma glucose, compared with placebo, with exenatide producing the greatest reduction. Exenatide, semaglutide, and higher doses of dulaglutide and taspoglutide also significantly reduced body weight by between 0.7 kg and 1.3 kg, compared with placebo. “Our results would therefore suggest clinically significant differences on three key indicators of metabolic control,” Dr. Zaccardi and his associates said (Ann. Intern. Med. 2015 Dec. 7. doi: 10.7326/M15-1432).
The risk for nausea also differed among the five agents. Taspoglutide carried the highest risk, which ranged from two- to ninefold higher than that of the other GLP-1RAs. With taspoglutide the risk for nausea was more than eight times higher than that with albiglutide.
Conversely, the risks for symptomatic hypoglycemia and rates of beneficial changes in blood pressure, lipid profiles, and C-reactive protein levels were similar across the five GLP-1RAs.
This meta-analysis was supported by an unrestricted grant from Sanofi-Aventis to the University of Leicester, and by the National Institute for Health Research and University Hospitals of Leicester and Loughborough University. Dr. Zaccardi reported having no relevant financial disclosures other than funding from Sanofi-Aventis; his associates reported ties to numerous industry sources, including the manufacturers of the five GLP-1RAs analyzed here.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Different once-weekly GLP-1RAs yield appreciably different effects on HbA1c, fasting plasma glucose, body weight, and nausea but very similar effects on hypoglycemia, blood pressure, lipids, and C-reactive protein levels.
Major finding: The 5 GLP-1RAs reduced the primary outcome measure, HbA1c, compared with placebo; dulaglutide produced the greatest reduction (1.4%).
Data source: A network meta-analysis of 34 phase III, randomized clinical trials published in 2008-2015 involving 21,126 participants with type 2 diabetes.
Disclosures: This meta-analysis was supported by an unrestricted grant from Sanofi-Aventis to the University of Leicester, and by the National Institute for Health Research and University Hospitals of Leicester and Loughborough University. Dr. Zaccardi reported having no relevant financial disclosures other than funding from Sanofi-Aventis; his associates reported ties to numerous industry sources, including the manufacturers of the five GLP-1RAs analyzed here.
Diabetes raises the cardiovascular risk higher in women than men
Women with type 2 diabetes mellitus have a twofold greater risk of developing coronary heart disease, compared with men with type 2 diabetes, according to a scientific statement from the American Heart Association.
In outlining the many sex differences in the impact of diabetes on cardiovascular disease risk, the authors of the statement have also called for more research into why there are these sex differences and how to treat them.
Around 1 in 10 adult Americans are estimated to have diabetes, and among those individuals, cardiovascular disease alone accounts for more than three-quarters of hospitalizations and half of all deaths.
“Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of [type 2 diabetes],” wrote American Heart Association Diabetes Committee Cochair Dr. Judith G. Regensteiner, director of the Center for Women’s Health Research at the University of Colorado at Denver, Aurora, and her coauthors.
Women with type 2 diabetes experience myocardial infarctions earlier in life than do men and are more likely to die from them, yet the rates of revascularization are lower in women with diabetes, compared with men, according to a statement published in the December 7 online issue of Circulation.
Women with diabetes also have more impaired endothelium-dependent vasodilation, worse atherogenic dyslipidemia, prothrombotic coagulation profile and higher metabolic syndrome prevalence than men with diabetes (Circulation. 2015 Dec 7. doi: 10.1161/CIR.0000000000000343).
Diabetes is also associated with a greater risk of incident heart failure and is a stronger risk factor for stroke in women than in men, although men with stroke are more likely to have diabetes.
Black and Hispanic women with type 2 diabetes also experience a disproportionately larger impact of the disease on their coronary artery disease and stroke risk, compared with men.
The authors of the statement also observed that, compared with men with diabetes, women are less likely to be taking statins, aspirin, ACE inhibitors, or beta-blockers, with the suggestion of lower medication adherence in women.
While the overall prevalence of diabetes is similar in men and women, there are sex-specific conditions such as gestational diabetes and polycystic ovary syndrome that contribute to women’s risk of the disease.
Research is needed to explore the full extent of sex differences between men and women, as this may have therapeutic implications, Dr. Regensteiner said in an interview.
“There really isn’t too much a clinician can do differently at this point because we don’t have information to guide changes in therapy,” she said, noting that any potential heart problems should be subject to the same level of scrutiny in women as in men.
The authors of the statement pointed out that observational evidence suggested women with diabetes may benefit from a higher frequency and intensity of physical activity than men with diabetes, and women with type 1 diabetes may experience greater improvements in hemoglobin A1c with exercise, compared with men.
The American Heart Association issued the statement. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
Women with type 2 diabetes mellitus have a twofold greater risk of developing coronary heart disease, compared with men with type 2 diabetes, according to a scientific statement from the American Heart Association.
In outlining the many sex differences in the impact of diabetes on cardiovascular disease risk, the authors of the statement have also called for more research into why there are these sex differences and how to treat them.
Around 1 in 10 adult Americans are estimated to have diabetes, and among those individuals, cardiovascular disease alone accounts for more than three-quarters of hospitalizations and half of all deaths.
“Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of [type 2 diabetes],” wrote American Heart Association Diabetes Committee Cochair Dr. Judith G. Regensteiner, director of the Center for Women’s Health Research at the University of Colorado at Denver, Aurora, and her coauthors.
Women with type 2 diabetes experience myocardial infarctions earlier in life than do men and are more likely to die from them, yet the rates of revascularization are lower in women with diabetes, compared with men, according to a statement published in the December 7 online issue of Circulation.
Women with diabetes also have more impaired endothelium-dependent vasodilation, worse atherogenic dyslipidemia, prothrombotic coagulation profile and higher metabolic syndrome prevalence than men with diabetes (Circulation. 2015 Dec 7. doi: 10.1161/CIR.0000000000000343).
Diabetes is also associated with a greater risk of incident heart failure and is a stronger risk factor for stroke in women than in men, although men with stroke are more likely to have diabetes.
Black and Hispanic women with type 2 diabetes also experience a disproportionately larger impact of the disease on their coronary artery disease and stroke risk, compared with men.
The authors of the statement also observed that, compared with men with diabetes, women are less likely to be taking statins, aspirin, ACE inhibitors, or beta-blockers, with the suggestion of lower medication adherence in women.
While the overall prevalence of diabetes is similar in men and women, there are sex-specific conditions such as gestational diabetes and polycystic ovary syndrome that contribute to women’s risk of the disease.
Research is needed to explore the full extent of sex differences between men and women, as this may have therapeutic implications, Dr. Regensteiner said in an interview.
“There really isn’t too much a clinician can do differently at this point because we don’t have information to guide changes in therapy,” she said, noting that any potential heart problems should be subject to the same level of scrutiny in women as in men.
The authors of the statement pointed out that observational evidence suggested women with diabetes may benefit from a higher frequency and intensity of physical activity than men with diabetes, and women with type 1 diabetes may experience greater improvements in hemoglobin A1c with exercise, compared with men.
The American Heart Association issued the statement. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
Women with type 2 diabetes mellitus have a twofold greater risk of developing coronary heart disease, compared with men with type 2 diabetes, according to a scientific statement from the American Heart Association.
In outlining the many sex differences in the impact of diabetes on cardiovascular disease risk, the authors of the statement have also called for more research into why there are these sex differences and how to treat them.
Around 1 in 10 adult Americans are estimated to have diabetes, and among those individuals, cardiovascular disease alone accounts for more than three-quarters of hospitalizations and half of all deaths.
“Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of [type 2 diabetes],” wrote American Heart Association Diabetes Committee Cochair Dr. Judith G. Regensteiner, director of the Center for Women’s Health Research at the University of Colorado at Denver, Aurora, and her coauthors.
Women with type 2 diabetes experience myocardial infarctions earlier in life than do men and are more likely to die from them, yet the rates of revascularization are lower in women with diabetes, compared with men, according to a statement published in the December 7 online issue of Circulation.
Women with diabetes also have more impaired endothelium-dependent vasodilation, worse atherogenic dyslipidemia, prothrombotic coagulation profile and higher metabolic syndrome prevalence than men with diabetes (Circulation. 2015 Dec 7. doi: 10.1161/CIR.0000000000000343).
Diabetes is also associated with a greater risk of incident heart failure and is a stronger risk factor for stroke in women than in men, although men with stroke are more likely to have diabetes.
Black and Hispanic women with type 2 diabetes also experience a disproportionately larger impact of the disease on their coronary artery disease and stroke risk, compared with men.
The authors of the statement also observed that, compared with men with diabetes, women are less likely to be taking statins, aspirin, ACE inhibitors, or beta-blockers, with the suggestion of lower medication adherence in women.
While the overall prevalence of diabetes is similar in men and women, there are sex-specific conditions such as gestational diabetes and polycystic ovary syndrome that contribute to women’s risk of the disease.
Research is needed to explore the full extent of sex differences between men and women, as this may have therapeutic implications, Dr. Regensteiner said in an interview.
“There really isn’t too much a clinician can do differently at this point because we don’t have information to guide changes in therapy,” she said, noting that any potential heart problems should be subject to the same level of scrutiny in women as in men.
The authors of the statement pointed out that observational evidence suggested women with diabetes may benefit from a higher frequency and intensity of physical activity than men with diabetes, and women with type 1 diabetes may experience greater improvements in hemoglobin A1c with exercise, compared with men.
The American Heart Association issued the statement. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
FROM CIRCULATION
Key clinical point: There are significant sex differences in the impact of diabetes on cardiovascular risk.
Major finding: Women with diabetes have a greater than twofold risk of coronary artery disease, compared with men with diabetes.
Data source: Scientific statement from the American Heart Association.
Disclosures: The statement is produced by the American Heart Association. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
VIDEO: Top hits from 2015 World Diabetes Congress
VANCOUVER, B.C. – So far, just one of the newer diabetes drugs has been shown to cut cardiovascular risk in type 2 diabetes.
Dr. Bernard Zinman, chairman of the meeting’s program committee, explained which one it is, and also shared other highlights from this year’s World Diabetes Congress.
In an interview at the meeting, Dr. Zinman offered new insights on beta-cell preservation, diabetes prevention, pancreas imaging, the microbiome, and the best combination therapies for early intervention.
“Diabetes is a very complex disease,” said Dr. Zinman, also the director of the diabetes center at Mount Sinai Hospital in Toronto and a professor of medicine at the University of Toronto. “To imagine that there’s one therapy or one magic bullet” that’s going to take care of all the problems in diabetes, “is very naive.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER, B.C. – So far, just one of the newer diabetes drugs has been shown to cut cardiovascular risk in type 2 diabetes.
Dr. Bernard Zinman, chairman of the meeting’s program committee, explained which one it is, and also shared other highlights from this year’s World Diabetes Congress.
In an interview at the meeting, Dr. Zinman offered new insights on beta-cell preservation, diabetes prevention, pancreas imaging, the microbiome, and the best combination therapies for early intervention.
“Diabetes is a very complex disease,” said Dr. Zinman, also the director of the diabetes center at Mount Sinai Hospital in Toronto and a professor of medicine at the University of Toronto. “To imagine that there’s one therapy or one magic bullet” that’s going to take care of all the problems in diabetes, “is very naive.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER, B.C. – So far, just one of the newer diabetes drugs has been shown to cut cardiovascular risk in type 2 diabetes.
Dr. Bernard Zinman, chairman of the meeting’s program committee, explained which one it is, and also shared other highlights from this year’s World Diabetes Congress.
In an interview at the meeting, Dr. Zinman offered new insights on beta-cell preservation, diabetes prevention, pancreas imaging, the microbiome, and the best combination therapies for early intervention.
“Diabetes is a very complex disease,” said Dr. Zinman, also the director of the diabetes center at Mount Sinai Hospital in Toronto and a professor of medicine at the University of Toronto. “To imagine that there’s one therapy or one magic bullet” that’s going to take care of all the problems in diabetes, “is very naive.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM THE WORLD DIABETES CONGRESS
VIDEO: Early response predicts weight loss success with liraglutide
VANCOUVER, B.C. – If patients haven’t lost 5% or more of their body weight after 16 weeks on liraglutide at a daily dose of 3 mg, the drug’s not going to work for weight loss and should be stopped, according to findings from a study by Novo Nordisk, the maker of liraglutide, that was presented at the World Diabetes Congress.
The 3-mg dose is marketed for weight loss as Saxenda; the drug is also sold as Victoza for type 2 diabetes at a dose of up to 1.8 mg.
The findings come from a new analysis of Novo Nordisk’s SCALE study, which included diet and exercise along with liraglutide 3 mg. About two-thirds of obese and prediabetic patients, versus about a third of patients on placebo, responded early to the 3-mg dose, losing 5% or more of their weight by week 16. By week 56, they had a mean weight loss of 11.5%. About half of patients with type 2 diabetes were early responders; they lost a mean of 9.3% at week 56. Nonresponders lost about 3.7% of their body weight after 56 weeks. Rates of hepatobiliary disorders with liraglutide were highest in nondiabetic subjects, at 3.5% (N Engl J Med. 2015 Jul 2;373[1]:11-22).
In an interview at the meeting, investigator Dr. Matthias Blüher, an endocrinology professor at the University of Leipzig (Germany), explained how to make use of the findings.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER, B.C. – If patients haven’t lost 5% or more of their body weight after 16 weeks on liraglutide at a daily dose of 3 mg, the drug’s not going to work for weight loss and should be stopped, according to findings from a study by Novo Nordisk, the maker of liraglutide, that was presented at the World Diabetes Congress.
The 3-mg dose is marketed for weight loss as Saxenda; the drug is also sold as Victoza for type 2 diabetes at a dose of up to 1.8 mg.
The findings come from a new analysis of Novo Nordisk’s SCALE study, which included diet and exercise along with liraglutide 3 mg. About two-thirds of obese and prediabetic patients, versus about a third of patients on placebo, responded early to the 3-mg dose, losing 5% or more of their weight by week 16. By week 56, they had a mean weight loss of 11.5%. About half of patients with type 2 diabetes were early responders; they lost a mean of 9.3% at week 56. Nonresponders lost about 3.7% of their body weight after 56 weeks. Rates of hepatobiliary disorders with liraglutide were highest in nondiabetic subjects, at 3.5% (N Engl J Med. 2015 Jul 2;373[1]:11-22).
In an interview at the meeting, investigator Dr. Matthias Blüher, an endocrinology professor at the University of Leipzig (Germany), explained how to make use of the findings.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER, B.C. – If patients haven’t lost 5% or more of their body weight after 16 weeks on liraglutide at a daily dose of 3 mg, the drug’s not going to work for weight loss and should be stopped, according to findings from a study by Novo Nordisk, the maker of liraglutide, that was presented at the World Diabetes Congress.
The 3-mg dose is marketed for weight loss as Saxenda; the drug is also sold as Victoza for type 2 diabetes at a dose of up to 1.8 mg.
The findings come from a new analysis of Novo Nordisk’s SCALE study, which included diet and exercise along with liraglutide 3 mg. About two-thirds of obese and prediabetic patients, versus about a third of patients on placebo, responded early to the 3-mg dose, losing 5% or more of their weight by week 16. By week 56, they had a mean weight loss of 11.5%. About half of patients with type 2 diabetes were early responders; they lost a mean of 9.3% at week 56. Nonresponders lost about 3.7% of their body weight after 56 weeks. Rates of hepatobiliary disorders with liraglutide were highest in nondiabetic subjects, at 3.5% (N Engl J Med. 2015 Jul 2;373[1]:11-22).
In an interview at the meeting, investigator Dr. Matthias Blüher, an endocrinology professor at the University of Leipzig (Germany), explained how to make use of the findings.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE WORLD DIABETES CONGRESS
Early-stage kidney disease benefits most from intensive glucose control
VANCOUVER – Intensive glucose control needs to begin early in the course of kidney disease to have its greatest renal protective effect in patients with type 2 diabetes, suggests a study reported at the World Diabetes Congress.
The conclusions are based on long-term follow-up of patients with type 2 diabetes and high vascular risk who were treated on an international randomized trial for about 5 years with either intensive or standard glucose control.
Results for the 8,494 patients at a median total follow-up of nearly a decade showed that patients with lesser stages of chronic kidney disease (CKD) at the start of the study benefited more from intensive over standard glucose control in reducing the risk of onset of dialysis or renal transplantation, reported Dr. Sophia Zoungas.
Reassuringly, intensive glucose lowering was not associated with an increase in the risk of death or cardiovascular death, regardless of patients’ CKD stage at baseline. And the higher relative risk of severe hypoglycemia with the intensive strategy was likewise similar across baseline CKD stages.
“We think that the commencement of intensive glucose control is particularly important early in the disease process, and hopefully we can get in before the development of significant kidney disease,” said Dr. Zoungas, an endocrinologist with the Monash University School of Public Health and Preventive Medicine in Clayton, Australia.
“The lesser benefit in those with moderately reduced kidney function (CKD stage 3 or greater) may indicate that the glucose-independent mechanisms of renal progression may predominate in the later stages of the disease,” she speculated.
These new data are helpful for real-world clinical care, according to session co-moderator Dr. David A. D’Alessio, a professor of medicine and director of the division of endocrinology, metabolism, and nutrition at Duke University, Durham, N.C.
“I think this study was really important. It shows the strength of doing a good trial and then not stopping at 5 years, but continuing to collect data,” he said in an interview. “These studies end up being really useful to practitioners because we oftentimes see patients whom we’ve followed for up to 10 years.”
The patients studied had participated in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), which tested both intensive glucose control and blood pressure–lowering therapy. After the 5-year trial, patients returned to their usual practitioners’ care but had continued collection of data. The ADVANCE post-trial observational study (ADVANCE-ON) analyses were conducted after a median total follow-up of 9.9 years. Main findings were previously published (N Engl J Med. 2014;371:1392-406).
The greater reduction in hemoglobin A1c levels seen with intensive glucose control versus standard control on the trial was lost after the trial ended, Dr. Zoungas noted. “So if there was any effect in ADVANCE-ON, it would be attributable to the difference achieved during the in-trial period,” she said.
Compared with peers in the standard control group, patients in the intensive control group had a reduction in the risk of end-stage kidney disease during the entire follow-up (hazard ratio, 0.54) similar to that seen while they were on the trial (hazard ratio, 0.35).
In subgroup analyses, the lower the baseline stage of CKD, the greater the edge of intensive glucose control over standard glucose control for reducing the risk of end-stage kidney disease. The hazard ratio was 0.16 for patients with no CKD at baseline, 0.34 for those with stage 1 or 2, and 0.89 for patients with stage 3 or higher (P = .04). The number needed to treat for 5 years to prevent one case of end-stage kidney disease during the entire follow-up was 259, 109, and 393, respectively.
“What’s interesting to note here is that during the overall 9.9 years of follow-up, we have smaller numbers needed to treat for those with no evidence of CKD or early-stage CKD,” Dr. Zoungas said.
The investigators explored treatment impact on all-cause mortality and cardiovascular mortality according to baseline CKD stage, prompted by findings from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showing increased risks of these outcomes in patients with mild to moderate CKD at baseline who received intensive glucose control (Kidney Int. 2015;87:649-59).
ADVANCE-ON results, in contrast, showed no significant elevation in risk with intensive control, either while patients were on the trial or for the total 9.9 years of follow-up even in those at the more advanced stages of CKD, Dr. Zoungas said.
The relative risk of severe hypoglycemia was similarly elevated with intensive control, compared with standard control across CKD subgroups, although the absolute risk was higher for those with stage 3 or higher disease.
Dr. Zoungas disclosed that she receives honoraria from Servier for speaking about ADVANCE and ADVANCE-ON at scientific meetings, and that she is on the speakers bureau and advisory boards for and receives travel support from Merck Sharp & Dohme and AstraZeneca/Bristol-Myers Squibb. The study was funded in part by Servier.
VANCOUVER – Intensive glucose control needs to begin early in the course of kidney disease to have its greatest renal protective effect in patients with type 2 diabetes, suggests a study reported at the World Diabetes Congress.
The conclusions are based on long-term follow-up of patients with type 2 diabetes and high vascular risk who were treated on an international randomized trial for about 5 years with either intensive or standard glucose control.
Results for the 8,494 patients at a median total follow-up of nearly a decade showed that patients with lesser stages of chronic kidney disease (CKD) at the start of the study benefited more from intensive over standard glucose control in reducing the risk of onset of dialysis or renal transplantation, reported Dr. Sophia Zoungas.
Reassuringly, intensive glucose lowering was not associated with an increase in the risk of death or cardiovascular death, regardless of patients’ CKD stage at baseline. And the higher relative risk of severe hypoglycemia with the intensive strategy was likewise similar across baseline CKD stages.
“We think that the commencement of intensive glucose control is particularly important early in the disease process, and hopefully we can get in before the development of significant kidney disease,” said Dr. Zoungas, an endocrinologist with the Monash University School of Public Health and Preventive Medicine in Clayton, Australia.
“The lesser benefit in those with moderately reduced kidney function (CKD stage 3 or greater) may indicate that the glucose-independent mechanisms of renal progression may predominate in the later stages of the disease,” she speculated.
These new data are helpful for real-world clinical care, according to session co-moderator Dr. David A. D’Alessio, a professor of medicine and director of the division of endocrinology, metabolism, and nutrition at Duke University, Durham, N.C.
“I think this study was really important. It shows the strength of doing a good trial and then not stopping at 5 years, but continuing to collect data,” he said in an interview. “These studies end up being really useful to practitioners because we oftentimes see patients whom we’ve followed for up to 10 years.”
The patients studied had participated in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), which tested both intensive glucose control and blood pressure–lowering therapy. After the 5-year trial, patients returned to their usual practitioners’ care but had continued collection of data. The ADVANCE post-trial observational study (ADVANCE-ON) analyses were conducted after a median total follow-up of 9.9 years. Main findings were previously published (N Engl J Med. 2014;371:1392-406).
The greater reduction in hemoglobin A1c levels seen with intensive glucose control versus standard control on the trial was lost after the trial ended, Dr. Zoungas noted. “So if there was any effect in ADVANCE-ON, it would be attributable to the difference achieved during the in-trial period,” she said.
Compared with peers in the standard control group, patients in the intensive control group had a reduction in the risk of end-stage kidney disease during the entire follow-up (hazard ratio, 0.54) similar to that seen while they were on the trial (hazard ratio, 0.35).
In subgroup analyses, the lower the baseline stage of CKD, the greater the edge of intensive glucose control over standard glucose control for reducing the risk of end-stage kidney disease. The hazard ratio was 0.16 for patients with no CKD at baseline, 0.34 for those with stage 1 or 2, and 0.89 for patients with stage 3 or higher (P = .04). The number needed to treat for 5 years to prevent one case of end-stage kidney disease during the entire follow-up was 259, 109, and 393, respectively.
“What’s interesting to note here is that during the overall 9.9 years of follow-up, we have smaller numbers needed to treat for those with no evidence of CKD or early-stage CKD,” Dr. Zoungas said.
The investigators explored treatment impact on all-cause mortality and cardiovascular mortality according to baseline CKD stage, prompted by findings from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showing increased risks of these outcomes in patients with mild to moderate CKD at baseline who received intensive glucose control (Kidney Int. 2015;87:649-59).
ADVANCE-ON results, in contrast, showed no significant elevation in risk with intensive control, either while patients were on the trial or for the total 9.9 years of follow-up even in those at the more advanced stages of CKD, Dr. Zoungas said.
The relative risk of severe hypoglycemia was similarly elevated with intensive control, compared with standard control across CKD subgroups, although the absolute risk was higher for those with stage 3 or higher disease.
Dr. Zoungas disclosed that she receives honoraria from Servier for speaking about ADVANCE and ADVANCE-ON at scientific meetings, and that she is on the speakers bureau and advisory boards for and receives travel support from Merck Sharp & Dohme and AstraZeneca/Bristol-Myers Squibb. The study was funded in part by Servier.
VANCOUVER – Intensive glucose control needs to begin early in the course of kidney disease to have its greatest renal protective effect in patients with type 2 diabetes, suggests a study reported at the World Diabetes Congress.
The conclusions are based on long-term follow-up of patients with type 2 diabetes and high vascular risk who were treated on an international randomized trial for about 5 years with either intensive or standard glucose control.
Results for the 8,494 patients at a median total follow-up of nearly a decade showed that patients with lesser stages of chronic kidney disease (CKD) at the start of the study benefited more from intensive over standard glucose control in reducing the risk of onset of dialysis or renal transplantation, reported Dr. Sophia Zoungas.
Reassuringly, intensive glucose lowering was not associated with an increase in the risk of death or cardiovascular death, regardless of patients’ CKD stage at baseline. And the higher relative risk of severe hypoglycemia with the intensive strategy was likewise similar across baseline CKD stages.
“We think that the commencement of intensive glucose control is particularly important early in the disease process, and hopefully we can get in before the development of significant kidney disease,” said Dr. Zoungas, an endocrinologist with the Monash University School of Public Health and Preventive Medicine in Clayton, Australia.
“The lesser benefit in those with moderately reduced kidney function (CKD stage 3 or greater) may indicate that the glucose-independent mechanisms of renal progression may predominate in the later stages of the disease,” she speculated.
These new data are helpful for real-world clinical care, according to session co-moderator Dr. David A. D’Alessio, a professor of medicine and director of the division of endocrinology, metabolism, and nutrition at Duke University, Durham, N.C.
“I think this study was really important. It shows the strength of doing a good trial and then not stopping at 5 years, but continuing to collect data,” he said in an interview. “These studies end up being really useful to practitioners because we oftentimes see patients whom we’ve followed for up to 10 years.”
The patients studied had participated in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), which tested both intensive glucose control and blood pressure–lowering therapy. After the 5-year trial, patients returned to their usual practitioners’ care but had continued collection of data. The ADVANCE post-trial observational study (ADVANCE-ON) analyses were conducted after a median total follow-up of 9.9 years. Main findings were previously published (N Engl J Med. 2014;371:1392-406).
The greater reduction in hemoglobin A1c levels seen with intensive glucose control versus standard control on the trial was lost after the trial ended, Dr. Zoungas noted. “So if there was any effect in ADVANCE-ON, it would be attributable to the difference achieved during the in-trial period,” she said.
Compared with peers in the standard control group, patients in the intensive control group had a reduction in the risk of end-stage kidney disease during the entire follow-up (hazard ratio, 0.54) similar to that seen while they were on the trial (hazard ratio, 0.35).
In subgroup analyses, the lower the baseline stage of CKD, the greater the edge of intensive glucose control over standard glucose control for reducing the risk of end-stage kidney disease. The hazard ratio was 0.16 for patients with no CKD at baseline, 0.34 for those with stage 1 or 2, and 0.89 for patients with stage 3 or higher (P = .04). The number needed to treat for 5 years to prevent one case of end-stage kidney disease during the entire follow-up was 259, 109, and 393, respectively.
“What’s interesting to note here is that during the overall 9.9 years of follow-up, we have smaller numbers needed to treat for those with no evidence of CKD or early-stage CKD,” Dr. Zoungas said.
The investigators explored treatment impact on all-cause mortality and cardiovascular mortality according to baseline CKD stage, prompted by findings from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial showing increased risks of these outcomes in patients with mild to moderate CKD at baseline who received intensive glucose control (Kidney Int. 2015;87:649-59).
ADVANCE-ON results, in contrast, showed no significant elevation in risk with intensive control, either while patients were on the trial or for the total 9.9 years of follow-up even in those at the more advanced stages of CKD, Dr. Zoungas said.
The relative risk of severe hypoglycemia was similarly elevated with intensive control, compared with standard control across CKD subgroups, although the absolute risk was higher for those with stage 3 or higher disease.
Dr. Zoungas disclosed that she receives honoraria from Servier for speaking about ADVANCE and ADVANCE-ON at scientific meetings, and that she is on the speakers bureau and advisory boards for and receives travel support from Merck Sharp & Dohme and AstraZeneca/Bristol-Myers Squibb. The study was funded in part by Servier.
AT THE WORLD DIABETES CONGRESS
Key clinical point: The benefit of intensive glucose control in reducing the risk of end-stage kidney disease is greatest when started before patients develop renal disease.
Major finding: The lower the stage of chronic kidney disease at baseline, the greater the relative reduction in risk of end-stage kidney disease with intensive vs. standard glucose control (P = .04).
Data source: A post-trial observational study of 8,494 patients with type 2 diabetes and high vascular risk (ADVANCE-ON study).
Disclosures: Dr. Zoungas disclosed that she receives honoraria from Servier for speaking about ADVANCE and ADVANCE-ON at scientific meetings, and that she is on the speakers bureau and advisory boards for and receives travel support from Merck Sharp & Dohme and AstraZeneca/Bristol-Myers Squibb. The study was funded in part by Servier.
AHA: Should BP targets be higher in asymptomatic aortic stenosis?
ORLANDO – Optimal blood pressure in patients with asymptomatic mild to moderate aortic stenosis is 140-159 mm Hg for systolic and 70-89 mm Hg for diastolic, according to an analysis of all-cause mortality in the world’s largest data set of such patients with longitudinal follow-up and endpoint evaluation.
Within those target blood pressure ranges, the nadir in terms of all-cause mortality – and thus the true optimal blood pressure – is about 145/82 mm Hg, Dr. Kristian Wachtell reported at the American Heart Association scientific sessions.
He presented an analysis of 1,873 asymptomatic patients with mild to moderate aortic stenosis (AS) and a peak aortic-jet velocity of 2.5-4.0 M/sec upon enrollment in the Simvastatin Ezetimibe in Aortic Stenosis (SEAS) trial. SEAS was a double-blind, multicenter study in which participants were randomized to 40 mg of simvastatin plus 10 mg of ezetimibe per day or placebo and followed for a mean of 4.3 years. Half of them had a history of hypertension at baseline.
As previously reported (N Engl J Med. 2008 Sep 25;359[13]:1343-56), SEAS was a negative trial. Lipid-lowering therapy didn’t affect AS progression or aortic valve–related outcomes. On the plus side, the SEAS cohort is the world’s largest population of patients with asymptomatic AS followed prospectively for clinical endpoints, noted Dr. Wachtell of Oslo University.
He and his coinvestigators decided to plot all-cause mortality versus average blood pressure in the SEAS cohort because of the paucity of data regarding blood pressure and antihypertensive therapy in patients with asymptomatic AS. Neither the 2014 ACC/AHA guidelines for management of valvular heart disease (Circulation. 2014 Jun 10;129[23]:e521-643) nor the European guidelines provide recommendations for optimal blood pressure targets in patients with asymptomatic AS, even though AS is the third most common cardiac disease, behind hypertension and coronary artery disease.
Moreover, nearly 100,000 aortic valve replacements are done per year in the United States as a consequence of AS. And AS and hypertension go hand in hand, with the prevalence of hypertension among patients with AS cited as 50% or more in multiple studies, the cardiologist continued.
In a multivariate analysis adjusted for aortic valve area index and peak velocity, heart failure, MI, and aortic valve replacement during follow-up, all-cause mortality showed a U-shaped relationship with blood pressure. A systolic blood pressure below 120 mm Hg was associated with a 5-fold increased risk of mortality, a systolic of 120-139 mm Hg carried a 1.5-fold increased risk, and a diastolic blood pressure of 90 mm Hg or more was associated with a 1.9-fold increased risk.
“Patients with low systolic blood pressure had an increased mortality risk and should probably undertake individual clinical assessment for blood pressure control and evaluation of their AS,” Dr. Wachtell said.
The first question audience members asked was, “What about SPRINT?” The SPRINT trial, presented elsewhere at the meeting, was a practice-changing study that was the talk of the conference. It redefined the systolic blood pressure treatment target as less than 120 mm Hg instead of less than 140 mm Hg in hypertensive patients (N Engl J Med. 2015 Nov 9. doi: 10.1056/NEJMoa1511939).
“I think it’s most likely that for blood pressure, one size does not fit all,” Dr. Wachtell replied. “The extent of target organ damage – and you could say that aortic stenosis is actually target organ damage, like atrial fibrillation or left ventricular hypertrophy – warrants a different level of blood pressure.”
He added, however, that the SEAS analysis was based on observational data, and that’s a limitation.
“This is a qualified guess as to what blood pressures should be in patients with aortic stenosis,” he cautioned.
Dr. Wachtell reported having no conflicts of interest regarding his presentation.
ORLANDO – Optimal blood pressure in patients with asymptomatic mild to moderate aortic stenosis is 140-159 mm Hg for systolic and 70-89 mm Hg for diastolic, according to an analysis of all-cause mortality in the world’s largest data set of such patients with longitudinal follow-up and endpoint evaluation.
Within those target blood pressure ranges, the nadir in terms of all-cause mortality – and thus the true optimal blood pressure – is about 145/82 mm Hg, Dr. Kristian Wachtell reported at the American Heart Association scientific sessions.
He presented an analysis of 1,873 asymptomatic patients with mild to moderate aortic stenosis (AS) and a peak aortic-jet velocity of 2.5-4.0 M/sec upon enrollment in the Simvastatin Ezetimibe in Aortic Stenosis (SEAS) trial. SEAS was a double-blind, multicenter study in which participants were randomized to 40 mg of simvastatin plus 10 mg of ezetimibe per day or placebo and followed for a mean of 4.3 years. Half of them had a history of hypertension at baseline.
As previously reported (N Engl J Med. 2008 Sep 25;359[13]:1343-56), SEAS was a negative trial. Lipid-lowering therapy didn’t affect AS progression or aortic valve–related outcomes. On the plus side, the SEAS cohort is the world’s largest population of patients with asymptomatic AS followed prospectively for clinical endpoints, noted Dr. Wachtell of Oslo University.
He and his coinvestigators decided to plot all-cause mortality versus average blood pressure in the SEAS cohort because of the paucity of data regarding blood pressure and antihypertensive therapy in patients with asymptomatic AS. Neither the 2014 ACC/AHA guidelines for management of valvular heart disease (Circulation. 2014 Jun 10;129[23]:e521-643) nor the European guidelines provide recommendations for optimal blood pressure targets in patients with asymptomatic AS, even though AS is the third most common cardiac disease, behind hypertension and coronary artery disease.
Moreover, nearly 100,000 aortic valve replacements are done per year in the United States as a consequence of AS. And AS and hypertension go hand in hand, with the prevalence of hypertension among patients with AS cited as 50% or more in multiple studies, the cardiologist continued.
In a multivariate analysis adjusted for aortic valve area index and peak velocity, heart failure, MI, and aortic valve replacement during follow-up, all-cause mortality showed a U-shaped relationship with blood pressure. A systolic blood pressure below 120 mm Hg was associated with a 5-fold increased risk of mortality, a systolic of 120-139 mm Hg carried a 1.5-fold increased risk, and a diastolic blood pressure of 90 mm Hg or more was associated with a 1.9-fold increased risk.
“Patients with low systolic blood pressure had an increased mortality risk and should probably undertake individual clinical assessment for blood pressure control and evaluation of their AS,” Dr. Wachtell said.
The first question audience members asked was, “What about SPRINT?” The SPRINT trial, presented elsewhere at the meeting, was a practice-changing study that was the talk of the conference. It redefined the systolic blood pressure treatment target as less than 120 mm Hg instead of less than 140 mm Hg in hypertensive patients (N Engl J Med. 2015 Nov 9. doi: 10.1056/NEJMoa1511939).
“I think it’s most likely that for blood pressure, one size does not fit all,” Dr. Wachtell replied. “The extent of target organ damage – and you could say that aortic stenosis is actually target organ damage, like atrial fibrillation or left ventricular hypertrophy – warrants a different level of blood pressure.”
He added, however, that the SEAS analysis was based on observational data, and that’s a limitation.
“This is a qualified guess as to what blood pressures should be in patients with aortic stenosis,” he cautioned.
Dr. Wachtell reported having no conflicts of interest regarding his presentation.
ORLANDO – Optimal blood pressure in patients with asymptomatic mild to moderate aortic stenosis is 140-159 mm Hg for systolic and 70-89 mm Hg for diastolic, according to an analysis of all-cause mortality in the world’s largest data set of such patients with longitudinal follow-up and endpoint evaluation.
Within those target blood pressure ranges, the nadir in terms of all-cause mortality – and thus the true optimal blood pressure – is about 145/82 mm Hg, Dr. Kristian Wachtell reported at the American Heart Association scientific sessions.
He presented an analysis of 1,873 asymptomatic patients with mild to moderate aortic stenosis (AS) and a peak aortic-jet velocity of 2.5-4.0 M/sec upon enrollment in the Simvastatin Ezetimibe in Aortic Stenosis (SEAS) trial. SEAS was a double-blind, multicenter study in which participants were randomized to 40 mg of simvastatin plus 10 mg of ezetimibe per day or placebo and followed for a mean of 4.3 years. Half of them had a history of hypertension at baseline.
As previously reported (N Engl J Med. 2008 Sep 25;359[13]:1343-56), SEAS was a negative trial. Lipid-lowering therapy didn’t affect AS progression or aortic valve–related outcomes. On the plus side, the SEAS cohort is the world’s largest population of patients with asymptomatic AS followed prospectively for clinical endpoints, noted Dr. Wachtell of Oslo University.
He and his coinvestigators decided to plot all-cause mortality versus average blood pressure in the SEAS cohort because of the paucity of data regarding blood pressure and antihypertensive therapy in patients with asymptomatic AS. Neither the 2014 ACC/AHA guidelines for management of valvular heart disease (Circulation. 2014 Jun 10;129[23]:e521-643) nor the European guidelines provide recommendations for optimal blood pressure targets in patients with asymptomatic AS, even though AS is the third most common cardiac disease, behind hypertension and coronary artery disease.
Moreover, nearly 100,000 aortic valve replacements are done per year in the United States as a consequence of AS. And AS and hypertension go hand in hand, with the prevalence of hypertension among patients with AS cited as 50% or more in multiple studies, the cardiologist continued.
In a multivariate analysis adjusted for aortic valve area index and peak velocity, heart failure, MI, and aortic valve replacement during follow-up, all-cause mortality showed a U-shaped relationship with blood pressure. A systolic blood pressure below 120 mm Hg was associated with a 5-fold increased risk of mortality, a systolic of 120-139 mm Hg carried a 1.5-fold increased risk, and a diastolic blood pressure of 90 mm Hg or more was associated with a 1.9-fold increased risk.
“Patients with low systolic blood pressure had an increased mortality risk and should probably undertake individual clinical assessment for blood pressure control and evaluation of their AS,” Dr. Wachtell said.
The first question audience members asked was, “What about SPRINT?” The SPRINT trial, presented elsewhere at the meeting, was a practice-changing study that was the talk of the conference. It redefined the systolic blood pressure treatment target as less than 120 mm Hg instead of less than 140 mm Hg in hypertensive patients (N Engl J Med. 2015 Nov 9. doi: 10.1056/NEJMoa1511939).
“I think it’s most likely that for blood pressure, one size does not fit all,” Dr. Wachtell replied. “The extent of target organ damage – and you could say that aortic stenosis is actually target organ damage, like atrial fibrillation or left ventricular hypertrophy – warrants a different level of blood pressure.”
He added, however, that the SEAS analysis was based on observational data, and that’s a limitation.
“This is a qualified guess as to what blood pressures should be in patients with aortic stenosis,” he cautioned.
Dr. Wachtell reported having no conflicts of interest regarding his presentation.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: Optimal blood pressures in patients with asymptomatic aortic stenosis appear to be significantly higher than those identified for the general hypertensive population in the recent SPRINT trial.
Major finding: All-cause mortality in patients with asymptomatic mild to moderate aortic stenosis is lowest at a blood pressure of 145/82 mm Hg.
Data source: This was an analysis of all-cause mortality over a mean follow-up of 4.3 years in 1,873 patients with asymptomatic mild to moderate aortic stenosis.
Disclosures: This secondary analysis of a completed clinical trial was conducted without commercial support. The presenter reported having no financial conflicts.
VIDEO: Another worry about energy drinks in kids
VANCOUVER – At least one of the commercially available energy drinks plays havoc with blood sugar and insulin levels in teen users, according to research from the University of Calgary (Alta.).
Ten teenage boys and ten girls were randomized to one regular “5-hour energy” drink, or, as a control, the decaffeinated version of the product, and then given an oral glucose tolerance test 40 minutes later.
In the second phase, the kids switched over to the drink they didn’t get in the first go-round, and the tolerance testing was repeated. Blood testing was done at baseline and throughout the study.
Investigator Jane Shearer, Ph.D., of the university’s department of biochemistry and molecular biology, explained the results, and why she’s worried about them, in an interview at the World Diabetes Congress.
Five-hour energy is a sugar-free 2-ounce drink containing about 200 mg of caffeine in its regular-strength formulation.
The findings raise another red flag about energy drinks in kids, especially if they are prone to diabetes. Dr. Shearer also shared her thoughts on what to do to address the issue.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – At least one of the commercially available energy drinks plays havoc with blood sugar and insulin levels in teen users, according to research from the University of Calgary (Alta.).
Ten teenage boys and ten girls were randomized to one regular “5-hour energy” drink, or, as a control, the decaffeinated version of the product, and then given an oral glucose tolerance test 40 minutes later.
In the second phase, the kids switched over to the drink they didn’t get in the first go-round, and the tolerance testing was repeated. Blood testing was done at baseline and throughout the study.
Investigator Jane Shearer, Ph.D., of the university’s department of biochemistry and molecular biology, explained the results, and why she’s worried about them, in an interview at the World Diabetes Congress.
Five-hour energy is a sugar-free 2-ounce drink containing about 200 mg of caffeine in its regular-strength formulation.
The findings raise another red flag about energy drinks in kids, especially if they are prone to diabetes. Dr. Shearer also shared her thoughts on what to do to address the issue.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – At least one of the commercially available energy drinks plays havoc with blood sugar and insulin levels in teen users, according to research from the University of Calgary (Alta.).
Ten teenage boys and ten girls were randomized to one regular “5-hour energy” drink, or, as a control, the decaffeinated version of the product, and then given an oral glucose tolerance test 40 minutes later.
In the second phase, the kids switched over to the drink they didn’t get in the first go-round, and the tolerance testing was repeated. Blood testing was done at baseline and throughout the study.
Investigator Jane Shearer, Ph.D., of the university’s department of biochemistry and molecular biology, explained the results, and why she’s worried about them, in an interview at the World Diabetes Congress.
Five-hour energy is a sugar-free 2-ounce drink containing about 200 mg of caffeine in its regular-strength formulation.
The findings raise another red flag about energy drinks in kids, especially if they are prone to diabetes. Dr. Shearer also shared her thoughts on what to do to address the issue.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE WORLD DIABETES CONGRESS
