Amy Karon

Ten-year mortality rates in the RITA-3 trial were similar regardless of whether patients with non-ST-segment elevation acute coronary syndrome underwent invasive treatment routinely or selectively, researchers reported July 27 in the Journal of the American College of Cardiology.

Prospective trials therefore will need to keep exploring which patients benefit from routine early invasive treatment, Dr. Robert A. Henderson at Nottingham University Hospitals in the United Kingdom, and his associates, wrote.

The RITA-3 (Third Randomised Intervention Treatment of Angina) trial randomized 1,810 patients with non-ST segment elevation acute coronary syndrome (NSTEMI ACS) to either routine or selective invasive treatment. Routine treatment consisted of coronary arteriography within 72 hours of the index episode of myocardial ischemia, with myocardial revascularization when clinically indicated. The selective strategy centered on antiangina medications. Patients only underwent coronary arteriography if they experienced recurrent ischemic pain at rest or during minimal exertion, with transient or persistent electrocardiographic ischemia (J. Am. Coll. Cardiol. 2015; 66: 511-20 [10.1016/j.jacc.2015.05.051]).

At 5 years, routine invasive treatment had a lower odds of cardiovascular death and myocardial infarction than selective invasive treatment, as well as a lower odds of all-cause mortality, the researchers previously reported (Lancet. 2005; 366: 914-20).

But at 10 years, all-cause mortality was 25% for both groups, and rates of cardiovascular death were 15% and 16% for routine versus selective invasive strategies (P = 0.65), they wrote. Age, history of previous myocardial infarction, heart failure, smoking, diabetes, heart rate, and ST-segment depression all predicted 10-year mortality in the multivariable analysis, but randomization strategy did not, they added.

When the researchers stratified patients based on Global Registry of Acute Coronary Events (GRACE) scores, death rates ranged from 14% for low-risk patients to 56% for high-risk patients, but did not vary by treatment strategy. The results highlight the need for more trials of intervention strategies for NSTEMI ACS, the researchers concluded.

The British Heart Foundation funded the RITA-3 trial and received relevant support from Aventis Pharma. One of the study co-authors reported receiving grant support from The Medicines Company, and the authors reported having no relevant financial disclosures.

Ten-year mortality rates in the RITA-3 trial were similar regardless of whether patients with non-ST-segment elevation acute coronary syndrome underwent invasive treatment routinely or selectively, researchers reported July 27 in the Journal of the American College of Cardiology.

Prospective trials therefore will need to keep exploring which patients benefit from routine early invasive treatment, Dr. Robert A. Henderson at Nottingham University Hospitals in the United Kingdom, and his associates, wrote.

The RITA-3 (Third Randomised Intervention Treatment of Angina) trial randomized 1,810 patients with non-ST segment elevation acute coronary syndrome (NSTEMI ACS) to either routine or selective invasive treatment. Routine treatment consisted of coronary arteriography within 72 hours of the index episode of myocardial ischemia, with myocardial revascularization when clinically indicated. The selective strategy centered on antiangina medications. Patients only underwent coronary arteriography if they experienced recurrent ischemic pain at rest or during minimal exertion, with transient or persistent electrocardiographic ischemia (J. Am. Coll. Cardiol. 2015; 66: 511-20 [10.1016/j.jacc.2015.05.051]).

At 5 years, routine invasive treatment had a lower odds of cardiovascular death and myocardial infarction than selective invasive treatment, as well as a lower odds of all-cause mortality, the researchers previously reported (Lancet. 2005; 366: 914-20).

But at 10 years, all-cause mortality was 25% for both groups, and rates of cardiovascular death were 15% and 16% for routine versus selective invasive strategies (P = 0.65), they wrote. Age, history of previous myocardial infarction, heart failure, smoking, diabetes, heart rate, and ST-segment depression all predicted 10-year mortality in the multivariable analysis, but randomization strategy did not, they added.

When the researchers stratified patients based on Global Registry of Acute Coronary Events (GRACE) scores, death rates ranged from 14% for low-risk patients to 56% for high-risk patients, but did not vary by treatment strategy. The results highlight the need for more trials of intervention strategies for NSTEMI ACS, the researchers concluded.

The British Heart Foundation funded the RITA-3 trial and received relevant support from Aventis Pharma. One of the study co-authors reported receiving grant support from The Medicines Company, and the authors reported having no relevant financial disclosures.

Ten-year mortality rates in the RITA-3 trial were similar regardless of whether patients with non-ST-segment elevation acute coronary syndrome underwent invasive treatment routinely or selectively, researchers reported July 27 in the Journal of the American College of Cardiology.

Prospective trials therefore will need to keep exploring which patients benefit from routine early invasive treatment, Dr. Robert A. Henderson at Nottingham University Hospitals in the United Kingdom, and his associates, wrote.

The RITA-3 (Third Randomised Intervention Treatment of Angina) trial randomized 1,810 patients with non-ST segment elevation acute coronary syndrome (NSTEMI ACS) to either routine or selective invasive treatment. Routine treatment consisted of coronary arteriography within 72 hours of the index episode of myocardial ischemia, with myocardial revascularization when clinically indicated. The selective strategy centered on antiangina medications. Patients only underwent coronary arteriography if they experienced recurrent ischemic pain at rest or during minimal exertion, with transient or persistent electrocardiographic ischemia (J. Am. Coll. Cardiol. 2015; 66: 511-20 [10.1016/j.jacc.2015.05.051]).

At 5 years, routine invasive treatment had a lower odds of cardiovascular death and myocardial infarction than selective invasive treatment, as well as a lower odds of all-cause mortality, the researchers previously reported (Lancet. 2005; 366: 914-20).

But at 10 years, all-cause mortality was 25% for both groups, and rates of cardiovascular death were 15% and 16% for routine versus selective invasive strategies (P = 0.65), they wrote. Age, history of previous myocardial infarction, heart failure, smoking, diabetes, heart rate, and ST-segment depression all predicted 10-year mortality in the multivariable analysis, but randomization strategy did not, they added.

When the researchers stratified patients based on Global Registry of Acute Coronary Events (GRACE) scores, death rates ranged from 14% for low-risk patients to 56% for high-risk patients, but did not vary by treatment strategy. The results highlight the need for more trials of intervention strategies for NSTEMI ACS, the researchers concluded.

The British Heart Foundation funded the RITA-3 trial and received relevant support from Aventis Pharma. One of the study co-authors reported receiving grant support from The Medicines Company, and the authors reported having no relevant financial disclosures.

Patients with type 1 diabetes whose HbA_1c levels exceeded 9.1% before coronary artery bypass grafting were significantly more likely to die or suffer major coronary adverse events over the next 5 years than were those with better glycemic control, researchers reported.

And patients with the worst glycemic control had more than double the risk of death or major coronary adverse events (MACE) as those who were adequately controlled before surgery, Dr. Thomas Nyström at the Karolinska Institutet in Stockholm, Sweden and his associates reported July 27 in the Journal of the American College of Cardiology.

Diabetes affects about one in four patients who undergo revascularization for multivessel coronary artery disease. To understand the links between preoperative hemoglobin A_1c (HbA_1c) levels and adverse postoperative outcomes, the researchers conducted a nationwide, population-based study of 764 type 1 diabetes mellitus patients who underwent coronary artery bypass grafting in Sweden between 1997 and 2012 (J. Am. Coll. Cardiol. 2015; 66: 535-43 [doi: 10.1016/j.jacc.2015.05.054]).

After a median of 4.7 years of follow-up, 44% of patients had died or had experienced MACE, for an incidence rate of 82 events per 1,000 person years, according to the investigators. Risk of death or MACE in the 5 years after surgery was significantly higher when preoperative HbA_1c levels were 10% ore more compared with 7% or less, they said (hazard ratio, 2.25; 95% confidence interval, 1.29 to 3.94).

Risk of death or MACE also was significantly elevated for patients with levels of 9.1% to 10.0%.

“Interventions to achieve better control of blood glucose concentrations and other cardiovascular risk factors in patients with [type I diabetes mellitus] should be evaluated in prospective trials,” the investigators wrote.

The study was supported by the Swedish Society of Medicine, Karolinska Institutet Foundations and Funds, the Mats Kleberg Foundation, and the Swedish Heart and Lung Foundation. The researchers reported having no relevant financial disclosures.

Patients with type 1 diabetes whose HbA_1c levels exceeded 9.1% before coronary artery bypass grafting were significantly more likely to die or suffer major coronary adverse events over the next 5 years than were those with better glycemic control, researchers reported.

And patients with the worst glycemic control had more than double the risk of death or major coronary adverse events (MACE) as those who were adequately controlled before surgery, Dr. Thomas Nyström at the Karolinska Institutet in Stockholm, Sweden and his associates reported July 27 in the Journal of the American College of Cardiology.

Diabetes affects about one in four patients who undergo revascularization for multivessel coronary artery disease. To understand the links between preoperative hemoglobin A_1c (HbA_1c) levels and adverse postoperative outcomes, the researchers conducted a nationwide, population-based study of 764 type 1 diabetes mellitus patients who underwent coronary artery bypass grafting in Sweden between 1997 and 2012 (J. Am. Coll. Cardiol. 2015; 66: 535-43 [doi: 10.1016/j.jacc.2015.05.054]).

After a median of 4.7 years of follow-up, 44% of patients had died or had experienced MACE, for an incidence rate of 82 events per 1,000 person years, according to the investigators. Risk of death or MACE in the 5 years after surgery was significantly higher when preoperative HbA_1c levels were 10% ore more compared with 7% or less, they said (hazard ratio, 2.25; 95% confidence interval, 1.29 to 3.94).

Risk of death or MACE also was significantly elevated for patients with levels of 9.1% to 10.0%.

“Interventions to achieve better control of blood glucose concentrations and other cardiovascular risk factors in patients with [type I diabetes mellitus] should be evaluated in prospective trials,” the investigators wrote.

The study was supported by the Swedish Society of Medicine, Karolinska Institutet Foundations and Funds, the Mats Kleberg Foundation, and the Swedish Heart and Lung Foundation. The researchers reported having no relevant financial disclosures.

Patients with type 1 diabetes whose HbA_1c levels exceeded 9.1% before coronary artery bypass grafting were significantly more likely to die or suffer major coronary adverse events over the next 5 years than were those with better glycemic control, researchers reported.

And patients with the worst glycemic control had more than double the risk of death or major coronary adverse events (MACE) as those who were adequately controlled before surgery, Dr. Thomas Nyström at the Karolinska Institutet in Stockholm, Sweden and his associates reported July 27 in the Journal of the American College of Cardiology.

Diabetes affects about one in four patients who undergo revascularization for multivessel coronary artery disease. To understand the links between preoperative hemoglobin A_1c (HbA_1c) levels and adverse postoperative outcomes, the researchers conducted a nationwide, population-based study of 764 type 1 diabetes mellitus patients who underwent coronary artery bypass grafting in Sweden between 1997 and 2012 (J. Am. Coll. Cardiol. 2015; 66: 535-43 [doi: 10.1016/j.jacc.2015.05.054]).

After a median of 4.7 years of follow-up, 44% of patients had died or had experienced MACE, for an incidence rate of 82 events per 1,000 person years, according to the investigators. Risk of death or MACE in the 5 years after surgery was significantly higher when preoperative HbA_1c levels were 10% ore more compared with 7% or less, they said (hazard ratio, 2.25; 95% confidence interval, 1.29 to 3.94).

Risk of death or MACE also was significantly elevated for patients with levels of 9.1% to 10.0%.

“Interventions to achieve better control of blood glucose concentrations and other cardiovascular risk factors in patients with [type I diabetes mellitus] should be evaluated in prospective trials,” the investigators wrote.

The study was supported by the Swedish Society of Medicine, Karolinska Institutet Foundations and Funds, the Mats Kleberg Foundation, and the Swedish Heart and Lung Foundation. The researchers reported having no relevant financial disclosures.

Drug manufacturers did not report about 10% of serious and unexpected adverse events to the U.S. Food and Drug Administration within the required time period, investigators reported online in JAMA Internal Medicine.

Moreover, manufacturers were more likely to delay reporting serious and unexpected drug-related deaths than other AEs, said Paul Ma, Ph.D., of the University of Minnesota, Minneapolis, and his associates.

thegoodphoto/Thinkstock

“As the FDA uses this information to update drug warnings, delays in reporting can have important public health consequences, particularly if manufacturers selectively delay reporting based on relevant patient outcomes,” the researchers said. “While increased enforcement may decrease violations, a simple alternative would be to recommend direct submission of reports to the FDA rather than via the manufacturer.”

Health providers and consumers can report adverse events to either drug manufacturers or the FDA under current regulations. Manufacturers have 15 days to forward reports of “expedited” events, defined as both unexpected (not included in the current FDA label) and serious (deaths, life-threatening drug reactions, new or prolonged inpatient hospitalizations, persistent or major disabilities, or birth defects). Although the extent to which drug manufacturers followed the 15-day requirement was unknown, there had been media reports of delays, the researchers noted (JAMA Intern. Med. 2015 July 27 [doi: 10.1001/jamainternmed.2015.3565]).

To better quantify the problem, Dr. Ma and his associates studied expedited AEs reported to the FDA Adverse Event Reporting System between 2004 and June 2014. Among 1.6 million reports, manufacturers failed to report 9.94% within the 15-day window, including more than 40,000 deaths. “Strikingly, AEs with patient death were more likely to be delayed,” added the investigators. “It is possible that manufacturers spend additional time in verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.”

Manufacturers reported about 90% of AEs that did not involve death on time, compared with 88% of those that did involve death. Furthermore, patient death remained linked to delayed reporting after accounting for multiple concurrent prescriptions; who reported the AE to the manufacturer; whether reported electronically or on paper; and the age, sex, and weight of patients.

“Further research is needed to better understand the mechanisms behind the manufacturers’ delayed reporting and the optimal regulatory policy toward mandatory disclosures of AEs,” the researchers concluded.

The Minnesota Accounting Research Center and the National Institute of Aging helped fund the research. The investigators disclosed no conflicts of interest.

Drug manufacturers did not report about 10% of serious and unexpected adverse events to the U.S. Food and Drug Administration within the required time period, investigators reported online in JAMA Internal Medicine.

Moreover, manufacturers were more likely to delay reporting serious and unexpected drug-related deaths than other AEs, said Paul Ma, Ph.D., of the University of Minnesota, Minneapolis, and his associates.

thegoodphoto/Thinkstock

“As the FDA uses this information to update drug warnings, delays in reporting can have important public health consequences, particularly if manufacturers selectively delay reporting based on relevant patient outcomes,” the researchers said. “While increased enforcement may decrease violations, a simple alternative would be to recommend direct submission of reports to the FDA rather than via the manufacturer.”

Health providers and consumers can report adverse events to either drug manufacturers or the FDA under current regulations. Manufacturers have 15 days to forward reports of “expedited” events, defined as both unexpected (not included in the current FDA label) and serious (deaths, life-threatening drug reactions, new or prolonged inpatient hospitalizations, persistent or major disabilities, or birth defects). Although the extent to which drug manufacturers followed the 15-day requirement was unknown, there had been media reports of delays, the researchers noted (JAMA Intern. Med. 2015 July 27 [doi: 10.1001/jamainternmed.2015.3565]).

To better quantify the problem, Dr. Ma and his associates studied expedited AEs reported to the FDA Adverse Event Reporting System between 2004 and June 2014. Among 1.6 million reports, manufacturers failed to report 9.94% within the 15-day window, including more than 40,000 deaths. “Strikingly, AEs with patient death were more likely to be delayed,” added the investigators. “It is possible that manufacturers spend additional time in verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.”

Manufacturers reported about 90% of AEs that did not involve death on time, compared with 88% of those that did involve death. Furthermore, patient death remained linked to delayed reporting after accounting for multiple concurrent prescriptions; who reported the AE to the manufacturer; whether reported electronically or on paper; and the age, sex, and weight of patients.

“Further research is needed to better understand the mechanisms behind the manufacturers’ delayed reporting and the optimal regulatory policy toward mandatory disclosures of AEs,” the researchers concluded.

The Minnesota Accounting Research Center and the National Institute of Aging helped fund the research. The investigators disclosed no conflicts of interest.

Drug manufacturers did not report about 10% of serious and unexpected adverse events to the U.S. Food and Drug Administration within the required time period, investigators reported online in JAMA Internal Medicine.

Moreover, manufacturers were more likely to delay reporting serious and unexpected drug-related deaths than other AEs, said Paul Ma, Ph.D., of the University of Minnesota, Minneapolis, and his associates.

thegoodphoto/Thinkstock

“As the FDA uses this information to update drug warnings, delays in reporting can have important public health consequences, particularly if manufacturers selectively delay reporting based on relevant patient outcomes,” the researchers said. “While increased enforcement may decrease violations, a simple alternative would be to recommend direct submission of reports to the FDA rather than via the manufacturer.”

Health providers and consumers can report adverse events to either drug manufacturers or the FDA under current regulations. Manufacturers have 15 days to forward reports of “expedited” events, defined as both unexpected (not included in the current FDA label) and serious (deaths, life-threatening drug reactions, new or prolonged inpatient hospitalizations, persistent or major disabilities, or birth defects). Although the extent to which drug manufacturers followed the 15-day requirement was unknown, there had been media reports of delays, the researchers noted (JAMA Intern. Med. 2015 July 27 [doi: 10.1001/jamainternmed.2015.3565]).

To better quantify the problem, Dr. Ma and his associates studied expedited AEs reported to the FDA Adverse Event Reporting System between 2004 and June 2014. Among 1.6 million reports, manufacturers failed to report 9.94% within the 15-day window, including more than 40,000 deaths. “Strikingly, AEs with patient death were more likely to be delayed,” added the investigators. “It is possible that manufacturers spend additional time in verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.”

Manufacturers reported about 90% of AEs that did not involve death on time, compared with 88% of those that did involve death. Furthermore, patient death remained linked to delayed reporting after accounting for multiple concurrent prescriptions; who reported the AE to the manufacturer; whether reported electronically or on paper; and the age, sex, and weight of patients.

“Further research is needed to better understand the mechanisms behind the manufacturers’ delayed reporting and the optimal regulatory policy toward mandatory disclosures of AEs,” the researchers concluded.

The Minnesota Accounting Research Center and the National Institute of Aging helped fund the research. The investigators disclosed no conflicts of interest.

Insulin resistance was linked to decreased brain glucose metabolism and predicted worse memory function among late-middle-aged adults at risk for Alzheimer’s disease, researchers reported online July 27 in JAMA Neurology.

Based on the findings, “midlife may be a critical period for initiating treatments aimed at preventing or delaying the onset of Alzheimer’s disease,” said Auriel A. Willette, Ph.D., of Iowa State University, Ames, and his associates. Targeting insulin signaling might affect central glucose metabolism and should be studied in presymptomatic Alzheimer’s disease (AD), the researchers added.

©graphicsdunia4you/ThinkStock

Insulin is now known to play a key role in the brain, and patients with type 2 diabetes are at increased risk of AD, the investigators noted. They performed cognitive testing, blood assays, and fludeoxyglucose F 18 (FDG)–labeled positron emission tomography (PET) for 150 cognitively normal, late-middle-aged adults who averaged almost 61 years old. In all, 72% of participants were women, 69% had a parent with AD, about 41% had an APOE E4 allele, and almost 5% had type 2 diabetes mellitus, the investigators reported (JAMA Neurol. 2015 Jul. 27 [doi:10.1001/jamaneurol.2015.0613]). Based on the homeostatic model assessment, increased peripheral insulin resistance was significantly associated with decreased glucose metabolism, both globally (P < .01) and in large areas of the frontal, lateral parietal, and medial and lateral temporal lobes (all P < .05), Dr. Willette and his associates found.

Insulin resistance and lower glucose uptake were especially robustly associated in the left medial temporal lobe (R² = 0.178; P < .05), and lower glucose metabolism in this lobe was associated with worse immediate and delayed memory performance factors (P < .001 for both). “This finding provides a potential link between insulin resistance and cognitive decline,” they wrote.

The findings also support results from previous studies of older adults that have linked insulin resistance, hyperglycemia, and diabetes mellitus to hypometabolism on FDG-PET. “Insulin resistance and hyperglycemia are related conditions, and hyperglycemia, even in the prediabetic range, is associated with a significantly increased risk for later development of dementia,” they noted.

The study was funded by the National Institute on Aging, the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Iowa State University, and the William S. Middleton Memorial Veterans Hospital. The investigators declared having no relevant conflicts of interest.

Insulin resistance was linked to decreased brain glucose metabolism and predicted worse memory function among late-middle-aged adults at risk for Alzheimer’s disease, researchers reported online July 27 in JAMA Neurology.

Based on the findings, “midlife may be a critical period for initiating treatments aimed at preventing or delaying the onset of Alzheimer’s disease,” said Auriel A. Willette, Ph.D., of Iowa State University, Ames, and his associates. Targeting insulin signaling might affect central glucose metabolism and should be studied in presymptomatic Alzheimer’s disease (AD), the researchers added.

©graphicsdunia4you/ThinkStock

Insulin is now known to play a key role in the brain, and patients with type 2 diabetes are at increased risk of AD, the investigators noted. They performed cognitive testing, blood assays, and fludeoxyglucose F 18 (FDG)–labeled positron emission tomography (PET) for 150 cognitively normal, late-middle-aged adults who averaged almost 61 years old. In all, 72% of participants were women, 69% had a parent with AD, about 41% had an APOE E4 allele, and almost 5% had type 2 diabetes mellitus, the investigators reported (JAMA Neurol. 2015 Jul. 27 [doi:10.1001/jamaneurol.2015.0613]). Based on the homeostatic model assessment, increased peripheral insulin resistance was significantly associated with decreased glucose metabolism, both globally (P < .01) and in large areas of the frontal, lateral parietal, and medial and lateral temporal lobes (all P < .05), Dr. Willette and his associates found.

Insulin resistance and lower glucose uptake were especially robustly associated in the left medial temporal lobe (R² = 0.178; P < .05), and lower glucose metabolism in this lobe was associated with worse immediate and delayed memory performance factors (P < .001 for both). “This finding provides a potential link between insulin resistance and cognitive decline,” they wrote.

The findings also support results from previous studies of older adults that have linked insulin resistance, hyperglycemia, and diabetes mellitus to hypometabolism on FDG-PET. “Insulin resistance and hyperglycemia are related conditions, and hyperglycemia, even in the prediabetic range, is associated with a significantly increased risk for later development of dementia,” they noted.

The study was funded by the National Institute on Aging, the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Iowa State University, and the William S. Middleton Memorial Veterans Hospital. The investigators declared having no relevant conflicts of interest.

Insulin resistance was linked to decreased brain glucose metabolism and predicted worse memory function among late-middle-aged adults at risk for Alzheimer’s disease, researchers reported online July 27 in JAMA Neurology.

Based on the findings, “midlife may be a critical period for initiating treatments aimed at preventing or delaying the onset of Alzheimer’s disease,” said Auriel A. Willette, Ph.D., of Iowa State University, Ames, and his associates. Targeting insulin signaling might affect central glucose metabolism and should be studied in presymptomatic Alzheimer’s disease (AD), the researchers added.

©graphicsdunia4you/ThinkStock

Insulin is now known to play a key role in the brain, and patients with type 2 diabetes are at increased risk of AD, the investigators noted. They performed cognitive testing, blood assays, and fludeoxyglucose F 18 (FDG)–labeled positron emission tomography (PET) for 150 cognitively normal, late-middle-aged adults who averaged almost 61 years old. In all, 72% of participants were women, 69% had a parent with AD, about 41% had an APOE E4 allele, and almost 5% had type 2 diabetes mellitus, the investigators reported (JAMA Neurol. 2015 Jul. 27 [doi:10.1001/jamaneurol.2015.0613]). Based on the homeostatic model assessment, increased peripheral insulin resistance was significantly associated with decreased glucose metabolism, both globally (P < .01) and in large areas of the frontal, lateral parietal, and medial and lateral temporal lobes (all P < .05), Dr. Willette and his associates found.

Insulin resistance and lower glucose uptake were especially robustly associated in the left medial temporal lobe (R² = 0.178; P < .05), and lower glucose metabolism in this lobe was associated with worse immediate and delayed memory performance factors (P < .001 for both). “This finding provides a potential link between insulin resistance and cognitive decline,” they wrote.

The findings also support results from previous studies of older adults that have linked insulin resistance, hyperglycemia, and diabetes mellitus to hypometabolism on FDG-PET. “Insulin resistance and hyperglycemia are related conditions, and hyperglycemia, even in the prediabetic range, is associated with a significantly increased risk for later development of dementia,” they noted.

The study was funded by the National Institute on Aging, the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Iowa State University, and the William S. Middleton Memorial Veterans Hospital. The investigators declared having no relevant conflicts of interest.

Insulin resistance was linked to decreased brain glucose metabolism and predicted worse memory function among late-middle-aged adults at risk for Alzheimer’s disease, researchers reported online July 27 in JAMA Neurology.

Based on the findings, “midlife may be a critical period for initiating treatments aimed at preventing or delaying the onset of Alzheimer’s disease,” said Auriel A. Willette, Ph.D., of Iowa State University, Ames, and his associates. Targeting insulin signaling might affect central glucose metabolism and should be studied in presymptomatic Alzheimer’s disease (AD), the researchers added.

©graphicsdunia4you/ThinkStock

Insulin is now known to play a key role in the brain, and patients with type 2 diabetes are at increased risk of AD, the investigators noted. They performed cognitive testing, blood assays, and fludeoxyglucose F 18 (FDG)–labeled positron emission tomography (PET) for 150 cognitively normal, late-middle-aged adults who averaged almost 61 years old. In all, 72% of participants were women, 69% had a parent with AD, about 41% had an APOE E4 allele, and almost 5% had type 2 diabetes mellitus, the investigators reported (JAMA Neurol. 2015 Jul. 27 [doi:10.1001/jamaneurol.2015.0613]). Based on the homeostatic model assessment, increased peripheral insulin resistance was significantly associated with decreased glucose metabolism, both globally (P < .01) and in large areas of the frontal, lateral parietal, and medial and lateral temporal lobes (all P < .05), Dr. Willette and his associates found.

Insulin resistance and lower glucose uptake were especially robustly associated in the left medial temporal lobe (R² = 0.178; P < .05), and lower glucose metabolism in this lobe was associated with worse immediate and delayed memory performance factors (P < .001 for both). “This finding provides a potential link between insulin resistance and cognitive decline,” they wrote.

The findings also support results from previous studies of older adults that have linked insulin resistance, hyperglycemia, and diabetes mellitus to hypometabolism on FDG-PET. “Insulin resistance and hyperglycemia are related conditions, and hyperglycemia, even in the prediabetic range, is associated with a significantly increased risk for later development of dementia,” they noted.

The study was funded by the National Institute on Aging, the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Iowa State University, and the William S. Middleton Memorial Veterans Hospital. The investigators declared having no relevant conflicts of interest.

Insulin resistance was linked to decreased brain glucose metabolism and predicted worse memory function among late-middle-aged adults at risk for Alzheimer’s disease, researchers reported online July 27 in JAMA Neurology.

Based on the findings, “midlife may be a critical period for initiating treatments aimed at preventing or delaying the onset of Alzheimer’s disease,” said Auriel A. Willette, Ph.D., of Iowa State University, Ames, and his associates. Targeting insulin signaling might affect central glucose metabolism and should be studied in presymptomatic Alzheimer’s disease (AD), the researchers added.

©graphicsdunia4you/ThinkStock

Insulin is now known to play a key role in the brain, and patients with type 2 diabetes are at increased risk of AD, the investigators noted. They performed cognitive testing, blood assays, and fludeoxyglucose F 18 (FDG)–labeled positron emission tomography (PET) for 150 cognitively normal, late-middle-aged adults who averaged almost 61 years old. In all, 72% of participants were women, 69% had a parent with AD, about 41% had an APOE E4 allele, and almost 5% had type 2 diabetes mellitus, the investigators reported (JAMA Neurol. 2015 Jul. 27 [doi:10.1001/jamaneurol.2015.0613]). Based on the homeostatic model assessment, increased peripheral insulin resistance was significantly associated with decreased glucose metabolism, both globally (P < .01) and in large areas of the frontal, lateral parietal, and medial and lateral temporal lobes (all P < .05), Dr. Willette and his associates found.

Insulin resistance and lower glucose uptake were especially robustly associated in the left medial temporal lobe (R² = 0.178; P < .05), and lower glucose metabolism in this lobe was associated with worse immediate and delayed memory performance factors (P < .001 for both). “This finding provides a potential link between insulin resistance and cognitive decline,” they wrote.

The findings also support results from previous studies of older adults that have linked insulin resistance, hyperglycemia, and diabetes mellitus to hypometabolism on FDG-PET. “Insulin resistance and hyperglycemia are related conditions, and hyperglycemia, even in the prediabetic range, is associated with a significantly increased risk for later development of dementia,” they noted.

The study was funded by the National Institute on Aging, the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Iowa State University, and the William S. Middleton Memorial Veterans Hospital. The investigators declared having no relevant conflicts of interest.

Insulin resistance was linked to decreased brain glucose metabolism and predicted worse memory function among late-middle-aged adults at risk for Alzheimer’s disease, researchers reported online July 27 in JAMA Neurology.

Based on the findings, “midlife may be a critical period for initiating treatments aimed at preventing or delaying the onset of Alzheimer’s disease,” said Auriel A. Willette, Ph.D., of Iowa State University, Ames, and his associates. Targeting insulin signaling might affect central glucose metabolism and should be studied in presymptomatic Alzheimer’s disease (AD), the researchers added.

©graphicsdunia4you/ThinkStock

Insulin is now known to play a key role in the brain, and patients with type 2 diabetes are at increased risk of AD, the investigators noted. They performed cognitive testing, blood assays, and fludeoxyglucose F 18 (FDG)–labeled positron emission tomography (PET) for 150 cognitively normal, late-middle-aged adults who averaged almost 61 years old. In all, 72% of participants were women, 69% had a parent with AD, about 41% had an APOE E4 allele, and almost 5% had type 2 diabetes mellitus, the investigators reported (JAMA Neurol. 2015 Jul. 27 [doi:10.1001/jamaneurol.2015.0613]). Based on the homeostatic model assessment, increased peripheral insulin resistance was significantly associated with decreased glucose metabolism, both globally (P < .01) and in large areas of the frontal, lateral parietal, and medial and lateral temporal lobes (all P < .05), Dr. Willette and his associates found.

Insulin resistance and lower glucose uptake were especially robustly associated in the left medial temporal lobe (R² = 0.178; P < .05), and lower glucose metabolism in this lobe was associated with worse immediate and delayed memory performance factors (P < .001 for both). “This finding provides a potential link between insulin resistance and cognitive decline,” they wrote.

The findings also support results from previous studies of older adults that have linked insulin resistance, hyperglycemia, and diabetes mellitus to hypometabolism on FDG-PET. “Insulin resistance and hyperglycemia are related conditions, and hyperglycemia, even in the prediabetic range, is associated with a significantly increased risk for later development of dementia,” they noted.

The study was funded by the National Institute on Aging, the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Iowa State University, and the William S. Middleton Memorial Veterans Hospital. The investigators declared having no relevant conflicts of interest.

Aromatase inhibitors and bisphosphonates can improve survival in postmenopausal early-stage breast cancer, and combining the two drug classes can help negate their individual adverse effects, according to two studies published online in The Lancet.

The research offers “the best evidence yet for the effects of aromatase inhibitors and bisphosphonates on postmenopausal women with early breast cancer,” according to a news release by The Lancet that accompanied the reports.

© Ingram Publishing/Thinkstock

Breast cancer typically occurs after menopause and is usually detected early enough to be operable, but can metastasize years later in bone or other sites if dormant malignant cells become activated, noted researchers from the Early Breast Cancer Trialists’ Collaborative Group, which conducted both meta-analyses.

For the aromatase inhibitor (AI) study, researchers analyzed data from almost 32,000 postmenopausal women with estrogen receptor–positive (ER-positive) early breast cancer who had participated in nine randomized, multiyear trials comparing AIs with standard tamoxifen-based endocrine therapy. Compared with tamoxifen, AI therapy cut the chances of breast cancer recurrence by about 30% during years 0-1 and 2-4 (P less than .001), they reported. “However, in the 2014 ASCO guidelines on endocrine treatment of postmenopausal women with ER-positive early breast cancer, three of the four recommended options start with tamoxifen; a review seems appropriate,” the investigators noted (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)61074-1]). Treatment with AIs also appeared to cut 10-year breast cancer mortality by about 15% compared with tamoxifen, and to lower the risk of dying of breast cancer by about 40% compared with no endocrine therapy, the researchers reported. “The impact of AIs is particularly remarkable given how specific these drugs are – removing only the tiny amount of estrogen that remains in the circulation of women after the menopause – and given the extraordinary molecular differences between ER-positive tumors,” Dr. Mitch Dowsett, the lead author, said in a statement.

“But AI treatment is not free of side effects, and it’s important to ensure that women with significant side effects are supported to try to continue to take treatment and fully benefit from it,” added Dr. Dowsett of The Royal Marsden and The Institute of Cancer Research, both in London.

Because AIs can increase fracture risk, clinicians need to monitor treated patients’ bone health and should consider using bisphosphonates when indicated, Dr. Dowsett and his associates added. The study also linked AIs to a slightly lower rate of endometrial cancer compared with tamoxifen therapy, helping offset the increased fracture risk, they said.

For the second study, investigators analyzed data from more than 18,700 women who had participated in 26 randomized controlled trials of bisphosphonates that assessed breast cancer recurrence, distant metastasis, and mortality. Bisphosphonate treatment did not seem to affect outcomes in premenopausal women, they found. But in postmenopausal patients, treatment led to “highly significant reductions” in local recurrence (risk ratio, 0.86, 95% confidence interval, 0.78 to 0.94; P = .002), distant recurrence (P = .0003), bone recurrence (P = .0002) and breast cancer mortality (P = .002), they reported (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)60908-4]).

Use of bisphosphonates also was tied to a small drop in fracture rates, which was probably real based on studies of other groups of patients, they noted. While bisphosphonates have been used primarily to help prevent bone loss and fractures in postmenopausal women with ER-positive disease who are receiving AIs, the findings show an additional oncological benefit “and suggest that adjuvant bisphosphonates should be considered in a broader range of postmenopausal women,” the researchers concluded. They were unable to assess rates of osteonecrosis of the jaw, but past reports point to rates of about 1% of patients on clodronate, ibandronate, or 6-monthly zoledronic acid therapy, and about 2% of those receiving more intensive zoledronic acid treatment, they noted.

Cancer Research UK and the UK Medical Research Council funded both studies. Ten authors from the AI study and eight authors from the bisphosphonate study reported financial relationships with a number of pharmaceutical companies.

Aromatase inhibitors and bisphosphonates can improve survival in postmenopausal early-stage breast cancer, and combining the two drug classes can help negate their individual adverse effects, according to two studies published online in The Lancet.

The research offers “the best evidence yet for the effects of aromatase inhibitors and bisphosphonates on postmenopausal women with early breast cancer,” according to a news release by The Lancet that accompanied the reports.

© Ingram Publishing/Thinkstock

Breast cancer typically occurs after menopause and is usually detected early enough to be operable, but can metastasize years later in bone or other sites if dormant malignant cells become activated, noted researchers from the Early Breast Cancer Trialists’ Collaborative Group, which conducted both meta-analyses.

For the aromatase inhibitor (AI) study, researchers analyzed data from almost 32,000 postmenopausal women with estrogen receptor–positive (ER-positive) early breast cancer who had participated in nine randomized, multiyear trials comparing AIs with standard tamoxifen-based endocrine therapy. Compared with tamoxifen, AI therapy cut the chances of breast cancer recurrence by about 30% during years 0-1 and 2-4 (P less than .001), they reported. “However, in the 2014 ASCO guidelines on endocrine treatment of postmenopausal women with ER-positive early breast cancer, three of the four recommended options start with tamoxifen; a review seems appropriate,” the investigators noted (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)61074-1]). Treatment with AIs also appeared to cut 10-year breast cancer mortality by about 15% compared with tamoxifen, and to lower the risk of dying of breast cancer by about 40% compared with no endocrine therapy, the researchers reported. “The impact of AIs is particularly remarkable given how specific these drugs are – removing only the tiny amount of estrogen that remains in the circulation of women after the menopause – and given the extraordinary molecular differences between ER-positive tumors,” Dr. Mitch Dowsett, the lead author, said in a statement.

“But AI treatment is not free of side effects, and it’s important to ensure that women with significant side effects are supported to try to continue to take treatment and fully benefit from it,” added Dr. Dowsett of The Royal Marsden and The Institute of Cancer Research, both in London.

Because AIs can increase fracture risk, clinicians need to monitor treated patients’ bone health and should consider using bisphosphonates when indicated, Dr. Dowsett and his associates added. The study also linked AIs to a slightly lower rate of endometrial cancer compared with tamoxifen therapy, helping offset the increased fracture risk, they said.

For the second study, investigators analyzed data from more than 18,700 women who had participated in 26 randomized controlled trials of bisphosphonates that assessed breast cancer recurrence, distant metastasis, and mortality. Bisphosphonate treatment did not seem to affect outcomes in premenopausal women, they found. But in postmenopausal patients, treatment led to “highly significant reductions” in local recurrence (risk ratio, 0.86, 95% confidence interval, 0.78 to 0.94; P = .002), distant recurrence (P = .0003), bone recurrence (P = .0002) and breast cancer mortality (P = .002), they reported (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)60908-4]).

Use of bisphosphonates also was tied to a small drop in fracture rates, which was probably real based on studies of other groups of patients, they noted. While bisphosphonates have been used primarily to help prevent bone loss and fractures in postmenopausal women with ER-positive disease who are receiving AIs, the findings show an additional oncological benefit “and suggest that adjuvant bisphosphonates should be considered in a broader range of postmenopausal women,” the researchers concluded. They were unable to assess rates of osteonecrosis of the jaw, but past reports point to rates of about 1% of patients on clodronate, ibandronate, or 6-monthly zoledronic acid therapy, and about 2% of those receiving more intensive zoledronic acid treatment, they noted.

Cancer Research UK and the UK Medical Research Council funded both studies. Ten authors from the AI study and eight authors from the bisphosphonate study reported financial relationships with a number of pharmaceutical companies.

Aromatase inhibitors and bisphosphonates can improve survival in postmenopausal early-stage breast cancer, and combining the two drug classes can help negate their individual adverse effects, according to two studies published online in The Lancet.

The research offers “the best evidence yet for the effects of aromatase inhibitors and bisphosphonates on postmenopausal women with early breast cancer,” according to a news release by The Lancet that accompanied the reports.

© Ingram Publishing/Thinkstock

Breast cancer typically occurs after menopause and is usually detected early enough to be operable, but can metastasize years later in bone or other sites if dormant malignant cells become activated, noted researchers from the Early Breast Cancer Trialists’ Collaborative Group, which conducted both meta-analyses.

For the aromatase inhibitor (AI) study, researchers analyzed data from almost 32,000 postmenopausal women with estrogen receptor–positive (ER-positive) early breast cancer who had participated in nine randomized, multiyear trials comparing AIs with standard tamoxifen-based endocrine therapy. Compared with tamoxifen, AI therapy cut the chances of breast cancer recurrence by about 30% during years 0-1 and 2-4 (P less than .001), they reported. “However, in the 2014 ASCO guidelines on endocrine treatment of postmenopausal women with ER-positive early breast cancer, three of the four recommended options start with tamoxifen; a review seems appropriate,” the investigators noted (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)61074-1]). Treatment with AIs also appeared to cut 10-year breast cancer mortality by about 15% compared with tamoxifen, and to lower the risk of dying of breast cancer by about 40% compared with no endocrine therapy, the researchers reported. “The impact of AIs is particularly remarkable given how specific these drugs are – removing only the tiny amount of estrogen that remains in the circulation of women after the menopause – and given the extraordinary molecular differences between ER-positive tumors,” Dr. Mitch Dowsett, the lead author, said in a statement.

“But AI treatment is not free of side effects, and it’s important to ensure that women with significant side effects are supported to try to continue to take treatment and fully benefit from it,” added Dr. Dowsett of The Royal Marsden and The Institute of Cancer Research, both in London.

Because AIs can increase fracture risk, clinicians need to monitor treated patients’ bone health and should consider using bisphosphonates when indicated, Dr. Dowsett and his associates added. The study also linked AIs to a slightly lower rate of endometrial cancer compared with tamoxifen therapy, helping offset the increased fracture risk, they said.

For the second study, investigators analyzed data from more than 18,700 women who had participated in 26 randomized controlled trials of bisphosphonates that assessed breast cancer recurrence, distant metastasis, and mortality. Bisphosphonate treatment did not seem to affect outcomes in premenopausal women, they found. But in postmenopausal patients, treatment led to “highly significant reductions” in local recurrence (risk ratio, 0.86, 95% confidence interval, 0.78 to 0.94; P = .002), distant recurrence (P = .0003), bone recurrence (P = .0002) and breast cancer mortality (P = .002), they reported (Lancet 2015 July 24 [doi:10.1016/S0140-6736(15)60908-4]).

Use of bisphosphonates also was tied to a small drop in fracture rates, which was probably real based on studies of other groups of patients, they noted. While bisphosphonates have been used primarily to help prevent bone loss and fractures in postmenopausal women with ER-positive disease who are receiving AIs, the findings show an additional oncological benefit “and suggest that adjuvant bisphosphonates should be considered in a broader range of postmenopausal women,” the researchers concluded. They were unable to assess rates of osteonecrosis of the jaw, but past reports point to rates of about 1% of patients on clodronate, ibandronate, or 6-monthly zoledronic acid therapy, and about 2% of those receiving more intensive zoledronic acid treatment, they noted.

Cancer Research UK and the UK Medical Research Council funded both studies. Ten authors from the AI study and eight authors from the bisphosphonate study reported financial relationships with a number of pharmaceutical companies.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Antipsychotic use is down among children, but up among adolescents and young adults, a large retrospective study has found.

The decline between 2008 and 2010 follows several years of upward trends in antipsychotics prescribed to young people, said Dr. Mark Olfson at Columbia University in New York and his associates. “In view of evidence of widespread antipsychotic prescribing outside of U.S. Food and Drug Administration–labeled indications and concerns regarding the adverse metabolic effects of second-generation antipsychotics, this decline is a welcome development,” they wrote.

Research shows that children and adolescents taking antipsychotics are at a two- to threefold risk of developing type 2 diabetes than the general population (Curr. Diab. Rep. 2015 Aug. 15 [doi:10.1007/s11892-015-0623-4]). The drugs also increase the risk of obesity and associated metabolic disorders.

Several antipsychotics have shown efficacy in child and adolescent bipolar mania, adolescent schizophrenia, and irritability associated with autism, but in the outpatient pediatric setting, most patients who are prescribed antipsychotics do not have these diagnoses, the researchers noted. Instead, antipsychotics continue to be prescribed to children and younger adolescents for transient, age-limited behavioral problems for which there are evidence-based alternative treatments, Dr. Olfson and his colleagues wrote. To change the practice, they emphasized the need for quality measures, physician education, telepsychiatry programs, and better access to alternative psychosocial treatments (JAMA Psychiatry 2015 July 1 [doi:10.1001/jamapsychiatry.2015.0500]).

For the study, the researchers calculated the annual percentage of younger children (aged 1-6 years), older children (aged 7-12 years), adolescents, and young adults (aged 19-24 years) who filled at least one prescription for antipsychotics. Data came from the IMS LifeLink LRx Longitudinal Prescription database, which covers about 60% of U.S. retail pharmacies.

Between 2006 and 2010, antipsychotics were prescribed to 36,484 younger children, 226,914 older children, 335,737 adolescents, and 252,739 young adults in the database, equivalent to about 1.3 million patients aged 1-24 years old nationally, the investigators reported. Antipsychotic prescriptions fell from 0.14% to 0.11% among children aged 6 years or less, and from 0.85% to 0.80% among older children, but rose from 1.10% to 1.19% among adolescents, and from 0.69% to 0.84% among young adults, they reported.

The most common mental health diagnoses among patients prescribed antipsychotics were attention-deficit/hyperactivity disorder (ADHD) in younger children (52.5%), older children (60.1%) and adolescents (34.9%), and depression among young adults (34.5%), the researchers also reported. Particularly among males, antipsychotic and diagnostic trends suggested that the drugs were being prescribed not for psychotic symptoms, but for “impulsive and aggressive behaviors” that tend to peak in late childhood and usually subside by adolescence, they added.

The National Institutes of Health and Columbia University funded the study. The investigators declared no conflicts of interest.

Antipsychotic use is down among children, but up among adolescents and young adults, a large retrospective study has found.

The decline between 2008 and 2010 follows several years of upward trends in antipsychotics prescribed to young people, said Dr. Mark Olfson at Columbia University in New York and his associates. “In view of evidence of widespread antipsychotic prescribing outside of U.S. Food and Drug Administration–labeled indications and concerns regarding the adverse metabolic effects of second-generation antipsychotics, this decline is a welcome development,” they wrote.

Research shows that children and adolescents taking antipsychotics are at a two- to threefold risk of developing type 2 diabetes than the general population (Curr. Diab. Rep. 2015 Aug. 15 [doi:10.1007/s11892-015-0623-4]). The drugs also increase the risk of obesity and associated metabolic disorders.

Several antipsychotics have shown efficacy in child and adolescent bipolar mania, adolescent schizophrenia, and irritability associated with autism, but in the outpatient pediatric setting, most patients who are prescribed antipsychotics do not have these diagnoses, the researchers noted. Instead, antipsychotics continue to be prescribed to children and younger adolescents for transient, age-limited behavioral problems for which there are evidence-based alternative treatments, Dr. Olfson and his colleagues wrote. To change the practice, they emphasized the need for quality measures, physician education, telepsychiatry programs, and better access to alternative psychosocial treatments (JAMA Psychiatry 2015 July 1 [doi:10.1001/jamapsychiatry.2015.0500]).

For the study, the researchers calculated the annual percentage of younger children (aged 1-6 years), older children (aged 7-12 years), adolescents, and young adults (aged 19-24 years) who filled at least one prescription for antipsychotics. Data came from the IMS LifeLink LRx Longitudinal Prescription database, which covers about 60% of U.S. retail pharmacies.

Between 2006 and 2010, antipsychotics were prescribed to 36,484 younger children, 226,914 older children, 335,737 adolescents, and 252,739 young adults in the database, equivalent to about 1.3 million patients aged 1-24 years old nationally, the investigators reported. Antipsychotic prescriptions fell from 0.14% to 0.11% among children aged 6 years or less, and from 0.85% to 0.80% among older children, but rose from 1.10% to 1.19% among adolescents, and from 0.69% to 0.84% among young adults, they reported.

The most common mental health diagnoses among patients prescribed antipsychotics were attention-deficit/hyperactivity disorder (ADHD) in younger children (52.5%), older children (60.1%) and adolescents (34.9%), and depression among young adults (34.5%), the researchers also reported. Particularly among males, antipsychotic and diagnostic trends suggested that the drugs were being prescribed not for psychotic symptoms, but for “impulsive and aggressive behaviors” that tend to peak in late childhood and usually subside by adolescence, they added.

The National Institutes of Health and Columbia University funded the study. The investigators declared no conflicts of interest.

Antipsychotic use is down among children, but up among adolescents and young adults, a large retrospective study has found.

The decline between 2008 and 2010 follows several years of upward trends in antipsychotics prescribed to young people, said Dr. Mark Olfson at Columbia University in New York and his associates. “In view of evidence of widespread antipsychotic prescribing outside of U.S. Food and Drug Administration–labeled indications and concerns regarding the adverse metabolic effects of second-generation antipsychotics, this decline is a welcome development,” they wrote.

Research shows that children and adolescents taking antipsychotics are at a two- to threefold risk of developing type 2 diabetes than the general population (Curr. Diab. Rep. 2015 Aug. 15 [doi:10.1007/s11892-015-0623-4]). The drugs also increase the risk of obesity and associated metabolic disorders.

Several antipsychotics have shown efficacy in child and adolescent bipolar mania, adolescent schizophrenia, and irritability associated with autism, but in the outpatient pediatric setting, most patients who are prescribed antipsychotics do not have these diagnoses, the researchers noted. Instead, antipsychotics continue to be prescribed to children and younger adolescents for transient, age-limited behavioral problems for which there are evidence-based alternative treatments, Dr. Olfson and his colleagues wrote. To change the practice, they emphasized the need for quality measures, physician education, telepsychiatry programs, and better access to alternative psychosocial treatments (JAMA Psychiatry 2015 July 1 [doi:10.1001/jamapsychiatry.2015.0500]).

For the study, the researchers calculated the annual percentage of younger children (aged 1-6 years), older children (aged 7-12 years), adolescents, and young adults (aged 19-24 years) who filled at least one prescription for antipsychotics. Data came from the IMS LifeLink LRx Longitudinal Prescription database, which covers about 60% of U.S. retail pharmacies.

Between 2006 and 2010, antipsychotics were prescribed to 36,484 younger children, 226,914 older children, 335,737 adolescents, and 252,739 young adults in the database, equivalent to about 1.3 million patients aged 1-24 years old nationally, the investigators reported. Antipsychotic prescriptions fell from 0.14% to 0.11% among children aged 6 years or less, and from 0.85% to 0.80% among older children, but rose from 1.10% to 1.19% among adolescents, and from 0.69% to 0.84% among young adults, they reported.

The most common mental health diagnoses among patients prescribed antipsychotics were attention-deficit/hyperactivity disorder (ADHD) in younger children (52.5%), older children (60.1%) and adolescents (34.9%), and depression among young adults (34.5%), the researchers also reported. Particularly among males, antipsychotic and diagnostic trends suggested that the drugs were being prescribed not for psychotic symptoms, but for “impulsive and aggressive behaviors” that tend to peak in late childhood and usually subside by adolescence, they added.

The National Institutes of Health and Columbia University funded the study. The investigators declared no conflicts of interest.