Mary Ann Moon

Both patient age and the duration of type 2 diabetes independently determine the clinical course of the disease among adults aged 60 to 80-plus years, according to a report published online in JAMA Internal Medicine.

The cardiovascular complications of diabetes are considered the most common as well as the most serious complications in patients of all ages, and preventing them by concentrating on glycemic control has been the mainstay of diabetes management. But this large cohort study showed that among older patients and those with longer disease duration, hypoglycemia rates approached those of coronary artery disease, said Dr. Elbert S. Huang of the University of Chicago and his associates in the Diabetes and Aging Study.

This means that the core focus on glycemic control is inappropriate for a substantial number of older diabetes patients. "To the extent that hypoglycemia is an adverse effect of treatment, its emergence as a dominant ‘complication’ raises serious concerns about the acceptable limits of iatrogenesis," they noted.

Dr. Huang and his colleagues examined the clinical course of type 2 diabetes in older adults because "most of our current understanding" is based on studies from the 1990s," and diabetes care has evolved since that time.

They analyzed data from the Kaiser Permanente Northern California Diabetes Registry concerning 72,310 diabetes patients aged 60 years and older at baseline in 2004. These study participants were followed for up to 7 years (mean follow-up, 5.4 years) for acute hyperglycemic events requiring hospitalization; acute hypoglycemic events requiring emergency department visits or hospitalization; microvascular complications such as severe eye disease, incident end-stage renal disease, peripheral vascular disease, and amputation; nonfatal cardiovascular complications such as myocardial infarction, coronary artery bypass graft surgery, angioplasty, ischemic or hemorrhagic stroke, carotid endarterectomy, and congestive heart failure; and fatal complications of any kind.

The mean patient age was 71 years, and about 15% of the study population was aged 80 years and older. The cohort was ethnically diverse and had equal access to health care, and most patients were receiving statins and angiotensin-converting enzyme (ACE) inhibitors appropriately.

Both patient age and duration of type 2 diabetes had a significant, independent effect on which complications were likely to arise. "Most notably, the risk of hypoglycemia rose markedly" with increasing age and duration of disease, so that it outpaced both coronary and cerebrovascular events as the most common serious complication in this subset of the population, the investigators reported (JAMA Intern. Med. 2013 Dec. 9 [doi: 10.1001/jamainternmed.2013.12956]).

Hypoglycemia was even fairly frequent among younger patients: It was the fourth most common complication among patients in their 60s and the third most common among patients in their 70s.

The rate of hypoglycemic events ranged from a low of 3.0 per 1,000 person-years among the youngest patients with the shortest duration of disease to a high of 19.6 per 1,000 person-years among the oldest patients with the longest duration of disease. (The corresponding rates of coronary artery disease events were 8.5 and 24.1 per 1,000 person-years.) This suggests that intensive glycemic control may not be a helpful treatment goal and may even be harmful to the latter group.

In addition, among the oldest patients who had a long duration of diabetes (more than 10 years), the rate of acute hyperglycemic events was only 2.35 per 1,000 person-years. This also suggests that intensive glycemic control to guard against hyperglycemic events may not be helpful in such patients.

"Our observations ... provide additional support for the reorientation of care of older patients with diabetes away from intensive glycemic control as the core focus of management. The distinctive clinical course of different patient strata supports recommendations to individualize glycemic targets among older people," Dr. Huang and his associates said.

The Diabetes and Aging Study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the University of Chicago. No financial conflicts of interest were reported.

Both patient age and the duration of type 2 diabetes independently determine the clinical course of the disease among adults aged 60 to 80-plus years, according to a report published online in JAMA Internal Medicine.

The cardiovascular complications of diabetes are considered the most common as well as the most serious complications in patients of all ages, and preventing them by concentrating on glycemic control has been the mainstay of diabetes management. But this large cohort study showed that among older patients and those with longer disease duration, hypoglycemia rates approached those of coronary artery disease, said Dr. Elbert S. Huang of the University of Chicago and his associates in the Diabetes and Aging Study.

This means that the core focus on glycemic control is inappropriate for a substantial number of older diabetes patients. "To the extent that hypoglycemia is an adverse effect of treatment, its emergence as a dominant ‘complication’ raises serious concerns about the acceptable limits of iatrogenesis," they noted.

Dr. Huang and his colleagues examined the clinical course of type 2 diabetes in older adults because "most of our current understanding" is based on studies from the 1990s," and diabetes care has evolved since that time.

They analyzed data from the Kaiser Permanente Northern California Diabetes Registry concerning 72,310 diabetes patients aged 60 years and older at baseline in 2004. These study participants were followed for up to 7 years (mean follow-up, 5.4 years) for acute hyperglycemic events requiring hospitalization; acute hypoglycemic events requiring emergency department visits or hospitalization; microvascular complications such as severe eye disease, incident end-stage renal disease, peripheral vascular disease, and amputation; nonfatal cardiovascular complications such as myocardial infarction, coronary artery bypass graft surgery, angioplasty, ischemic or hemorrhagic stroke, carotid endarterectomy, and congestive heart failure; and fatal complications of any kind.

The mean patient age was 71 years, and about 15% of the study population was aged 80 years and older. The cohort was ethnically diverse and had equal access to health care, and most patients were receiving statins and angiotensin-converting enzyme (ACE) inhibitors appropriately.

Both patient age and duration of type 2 diabetes had a significant, independent effect on which complications were likely to arise. "Most notably, the risk of hypoglycemia rose markedly" with increasing age and duration of disease, so that it outpaced both coronary and cerebrovascular events as the most common serious complication in this subset of the population, the investigators reported (JAMA Intern. Med. 2013 Dec. 9 [doi: 10.1001/jamainternmed.2013.12956]).

Hypoglycemia was even fairly frequent among younger patients: It was the fourth most common complication among patients in their 60s and the third most common among patients in their 70s.

The rate of hypoglycemic events ranged from a low of 3.0 per 1,000 person-years among the youngest patients with the shortest duration of disease to a high of 19.6 per 1,000 person-years among the oldest patients with the longest duration of disease. (The corresponding rates of coronary artery disease events were 8.5 and 24.1 per 1,000 person-years.) This suggests that intensive glycemic control may not be a helpful treatment goal and may even be harmful to the latter group.

In addition, among the oldest patients who had a long duration of diabetes (more than 10 years), the rate of acute hyperglycemic events was only 2.35 per 1,000 person-years. This also suggests that intensive glycemic control to guard against hyperglycemic events may not be helpful in such patients.

"Our observations ... provide additional support for the reorientation of care of older patients with diabetes away from intensive glycemic control as the core focus of management. The distinctive clinical course of different patient strata supports recommendations to individualize glycemic targets among older people," Dr. Huang and his associates said.

The Diabetes and Aging Study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the University of Chicago. No financial conflicts of interest were reported.

Both patient age and the duration of type 2 diabetes independently determine the clinical course of the disease among adults aged 60 to 80-plus years, according to a report published online in JAMA Internal Medicine.

The cardiovascular complications of diabetes are considered the most common as well as the most serious complications in patients of all ages, and preventing them by concentrating on glycemic control has been the mainstay of diabetes management. But this large cohort study showed that among older patients and those with longer disease duration, hypoglycemia rates approached those of coronary artery disease, said Dr. Elbert S. Huang of the University of Chicago and his associates in the Diabetes and Aging Study.

This means that the core focus on glycemic control is inappropriate for a substantial number of older diabetes patients. "To the extent that hypoglycemia is an adverse effect of treatment, its emergence as a dominant ‘complication’ raises serious concerns about the acceptable limits of iatrogenesis," they noted.

Dr. Huang and his colleagues examined the clinical course of type 2 diabetes in older adults because "most of our current understanding" is based on studies from the 1990s," and diabetes care has evolved since that time.

They analyzed data from the Kaiser Permanente Northern California Diabetes Registry concerning 72,310 diabetes patients aged 60 years and older at baseline in 2004. These study participants were followed for up to 7 years (mean follow-up, 5.4 years) for acute hyperglycemic events requiring hospitalization; acute hypoglycemic events requiring emergency department visits or hospitalization; microvascular complications such as severe eye disease, incident end-stage renal disease, peripheral vascular disease, and amputation; nonfatal cardiovascular complications such as myocardial infarction, coronary artery bypass graft surgery, angioplasty, ischemic or hemorrhagic stroke, carotid endarterectomy, and congestive heart failure; and fatal complications of any kind.

The mean patient age was 71 years, and about 15% of the study population was aged 80 years and older. The cohort was ethnically diverse and had equal access to health care, and most patients were receiving statins and angiotensin-converting enzyme (ACE) inhibitors appropriately.

Both patient age and duration of type 2 diabetes had a significant, independent effect on which complications were likely to arise. "Most notably, the risk of hypoglycemia rose markedly" with increasing age and duration of disease, so that it outpaced both coronary and cerebrovascular events as the most common serious complication in this subset of the population, the investigators reported (JAMA Intern. Med. 2013 Dec. 9 [doi: 10.1001/jamainternmed.2013.12956]).

Hypoglycemia was even fairly frequent among younger patients: It was the fourth most common complication among patients in their 60s and the third most common among patients in their 70s.

The rate of hypoglycemic events ranged from a low of 3.0 per 1,000 person-years among the youngest patients with the shortest duration of disease to a high of 19.6 per 1,000 person-years among the oldest patients with the longest duration of disease. (The corresponding rates of coronary artery disease events were 8.5 and 24.1 per 1,000 person-years.) This suggests that intensive glycemic control may not be a helpful treatment goal and may even be harmful to the latter group.

In addition, among the oldest patients who had a long duration of diabetes (more than 10 years), the rate of acute hyperglycemic events was only 2.35 per 1,000 person-years. This also suggests that intensive glycemic control to guard against hyperglycemic events may not be helpful in such patients.

"Our observations ... provide additional support for the reorientation of care of older patients with diabetes away from intensive glycemic control as the core focus of management. The distinctive clinical course of different patient strata supports recommendations to individualize glycemic targets among older people," Dr. Huang and his associates said.

The Diabetes and Aging Study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the University of Chicago. No financial conflicts of interest were reported.

The prevalence of obesity has not changed appreciably among children or adults in the United States between 2003 and 2012, the most recent year for which data are available, according to a report published online Feb. 25 in JAMA.

Obesity prevalence was high at 16.9% among children and 34.9% among adults in 2011-2012, which does not differ significantly from the rates of 17.1% and 32.2%, respectively, in 2003-2004, said Cynthia L. Ogden, Ph.D., of the National Center for Health Statistics (NCHS), and her associates.

© kikkerdirk/Thinkstockphotos.com

They analyzed data from the National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the general U.S. population, to obtain the most recent estimates of obesity and to track any trends that may have occurred between the two time periods. The investigators focused on the records for 9,120 people aged 2 years and older who participated in the 2011-2012 NHANES.

For children aged 2-19 years in that survey, the prevalence of overweight or obesity was 31.8% and that of obesity alone was 16.9%, with no differences between boys and girls.

When the data were broken down by pediatric age groups, the rate of obesity was 8.4% in 2- to 5-year-olds, 17.7% in 6- to 11-year-olds, and 20.5% in 12- to 19-year-olds. There were no significant changes between this survey and the one in 2003-2004 except that the prevalence of obesity in the 2- to 5-year-old age group declined by 5 percentage points over time, the researchers said (JAMA 2014;311:806-14 [doi:10.1001/jama.2014.732]).

Among adults in the most recent survey, 68.5% were either overweight or obese; 34.9% were obese, and 6.4% were extremely obese. Again, there were no significant changes between this survey and the one in 2003-2004 except for an increase of 4 percentage points in obesity among women aged 60 and older. The NCHS released these data in 2012 (NCHS Data Brief January 2013).

"Obesity prevalence remains high, and thus it is important to continue surveillance," Dr. Ogden and her associates said.

The prevalence of obesity has not changed appreciably among children or adults in the United States between 2003 and 2012, the most recent year for which data are available, according to a report published online Feb. 25 in JAMA.

Obesity prevalence was high at 16.9% among children and 34.9% among adults in 2011-2012, which does not differ significantly from the rates of 17.1% and 32.2%, respectively, in 2003-2004, said Cynthia L. Ogden, Ph.D., of the National Center for Health Statistics (NCHS), and her associates.

© kikkerdirk/Thinkstockphotos.com

They analyzed data from the National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the general U.S. population, to obtain the most recent estimates of obesity and to track any trends that may have occurred between the two time periods. The investigators focused on the records for 9,120 people aged 2 years and older who participated in the 2011-2012 NHANES.

For children aged 2-19 years in that survey, the prevalence of overweight or obesity was 31.8% and that of obesity alone was 16.9%, with no differences between boys and girls.

When the data were broken down by pediatric age groups, the rate of obesity was 8.4% in 2- to 5-year-olds, 17.7% in 6- to 11-year-olds, and 20.5% in 12- to 19-year-olds. There were no significant changes between this survey and the one in 2003-2004 except that the prevalence of obesity in the 2- to 5-year-old age group declined by 5 percentage points over time, the researchers said (JAMA 2014;311:806-14 [doi:10.1001/jama.2014.732]).

Among adults in the most recent survey, 68.5% were either overweight or obese; 34.9% were obese, and 6.4% were extremely obese. Again, there were no significant changes between this survey and the one in 2003-2004 except for an increase of 4 percentage points in obesity among women aged 60 and older. The NCHS released these data in 2012 (NCHS Data Brief January 2013).

"Obesity prevalence remains high, and thus it is important to continue surveillance," Dr. Ogden and her associates said.

The prevalence of obesity has not changed appreciably among children or adults in the United States between 2003 and 2012, the most recent year for which data are available, according to a report published online Feb. 25 in JAMA.

Obesity prevalence was high at 16.9% among children and 34.9% among adults in 2011-2012, which does not differ significantly from the rates of 17.1% and 32.2%, respectively, in 2003-2004, said Cynthia L. Ogden, Ph.D., of the National Center for Health Statistics (NCHS), and her associates.

© kikkerdirk/Thinkstockphotos.com

They analyzed data from the National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the general U.S. population, to obtain the most recent estimates of obesity and to track any trends that may have occurred between the two time periods. The investigators focused on the records for 9,120 people aged 2 years and older who participated in the 2011-2012 NHANES.

For children aged 2-19 years in that survey, the prevalence of overweight or obesity was 31.8% and that of obesity alone was 16.9%, with no differences between boys and girls.

When the data were broken down by pediatric age groups, the rate of obesity was 8.4% in 2- to 5-year-olds, 17.7% in 6- to 11-year-olds, and 20.5% in 12- to 19-year-olds. There were no significant changes between this survey and the one in 2003-2004 except that the prevalence of obesity in the 2- to 5-year-old age group declined by 5 percentage points over time, the researchers said (JAMA 2014;311:806-14 [doi:10.1001/jama.2014.732]).

Among adults in the most recent survey, 68.5% were either overweight or obese; 34.9% were obese, and 6.4% were extremely obese. Again, there were no significant changes between this survey and the one in 2003-2004 except for an increase of 4 percentage points in obesity among women aged 60 and older. The NCHS released these data in 2012 (NCHS Data Brief January 2013).

"Obesity prevalence remains high, and thus it is important to continue surveillance," Dr. Ogden and her associates said.

Fifteen percent of eligible patients treated for acute coronary syndrome still are not given ACE inhibitors or angiotensin receptor blockers as recommended, according to data from a quality improvement program. The results were published online Feb. 25 in Circulation: Cardiovascular Quality and Outcomes.

Prescription rates for ACE inhibitors and ARBs were lowest among certain patients who are at greatest risk of adverse outcomes if they don’t take the drugs: those who had coronary artery bypass graft (CABG) surgery to treat their ACS and those with a history of renal insufficiency. And the use of ACE inhibitors and ARBs was lower than that of other evidence-based therapies, such as aspirin and beta-blockers.

"Thus, ongoing quality improvement initiatives are still necessary to help ensure appropriate secondary prevention is delivered," said Dr. Kevin R. Bainey and his associates in the Get With The Guidelines–Coronary Artery Disease (GWTG-CAD) program, a quality improvement effort of the American Heart Association that includes a national registry of coronary artery disease hospitalizations.

To obtain current figures on adherence to guidelines regarding medication after ACS, Dr. Bainey and his colleagues reviewed the records of 80,241 patients admitted to 311 hospitals participating in GWTG program in 2005-2009. The researchers included patients who met American College of Cardiology/AHA class I or class IIa criteria for receiving ACE inhibitor or ARB therapy.

A total of 60,847 patients met ACC/AHA class I risk criteria, for whom it is "strongly recommended that an ACE inhibitor or ARB be started and continued indefinitely." Yet, at the end of the study period, only 85% were discharged with an appropriate prescription: 69.8% received an ACE inhibitor prescription, 13.5% received an ARB prescription, and 1.7% received both. Those rates were lower at the beginning of the period.

A total of 19,394 patients met ACC/AHA class IIa risk criteria, for whom "the use of ACE inhibitor or ARB is reasonable and should be initiated." Yet only 69.3% were discharged with an appropriate prescription: 64.7% received an ACE inhibitor prescription, 4.0% received an ARB prescription, and 0.6% received both.

In comparison, 98% of eligible patients were discharged on aspirin and 97% were discharged on beta-blockers, said Dr. Bainey of the Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, and his associates.

Appropriate prescription of ACE inhibitors and ARBs was "strikingly" low in patients who had undergone CABG during the hospitalization; such patients were 50% less likely than were others to receive the drugs, even though they were at much higher risk. This trend has been noted in previous studies and provides "further evidence of a persistent care gap that requires immediate attention," the investigators said (Circ. Cardiovasc. Qual. Outcomes 2014 Feb. 25 [doi:10.1161/circoutcomes.113.000422]).

"Another striking imbalance in ACE/ARB prescription" occurred in patients with a history of renal insufficiency, who were 40% less likely than were others to receive the drugs. It is possible that clinicians are hesitant to prescribe these medications because of concerns about worsening renal failure or potentiating hyperkalemia. But those risks are extremely low, and "current evidence clearly supports the use of renin-angiotensin system (RAS) inhibitor in halting the progression of chronic kidney disease," Dr. Bainey and his associates said.

The use of ACE inhibitors and ARBs has increased substantially over the past decade, coincident with the implementation of quality assurance initiatives such as GWTG-CAD. It was reassuring that this study showed an increase in use early in the study period. But it appears that this increase has plateaued, "which should prompt further hospital quality improvement and continued monitored adherence to secondary prevention guidelines," they added.

GWTG-CAD is an American Heart Association program and is supported in part by Merck/Schering-Plough and Pfizer. Dr. Bainey reported no financial conflicts of interest; his associates reported numerous ties to industry sources.

Fifteen percent of eligible patients treated for acute coronary syndrome still are not given ACE inhibitors or angiotensin receptor blockers as recommended, according to data from a quality improvement program. The results were published online Feb. 25 in Circulation: Cardiovascular Quality and Outcomes.

Prescription rates for ACE inhibitors and ARBs were lowest among certain patients who are at greatest risk of adverse outcomes if they don’t take the drugs: those who had coronary artery bypass graft (CABG) surgery to treat their ACS and those with a history of renal insufficiency. And the use of ACE inhibitors and ARBs was lower than that of other evidence-based therapies, such as aspirin and beta-blockers.

"Thus, ongoing quality improvement initiatives are still necessary to help ensure appropriate secondary prevention is delivered," said Dr. Kevin R. Bainey and his associates in the Get With The Guidelines–Coronary Artery Disease (GWTG-CAD) program, a quality improvement effort of the American Heart Association that includes a national registry of coronary artery disease hospitalizations.

To obtain current figures on adherence to guidelines regarding medication after ACS, Dr. Bainey and his colleagues reviewed the records of 80,241 patients admitted to 311 hospitals participating in GWTG program in 2005-2009. The researchers included patients who met American College of Cardiology/AHA class I or class IIa criteria for receiving ACE inhibitor or ARB therapy.

A total of 60,847 patients met ACC/AHA class I risk criteria, for whom it is "strongly recommended that an ACE inhibitor or ARB be started and continued indefinitely." Yet, at the end of the study period, only 85% were discharged with an appropriate prescription: 69.8% received an ACE inhibitor prescription, 13.5% received an ARB prescription, and 1.7% received both. Those rates were lower at the beginning of the period.

A total of 19,394 patients met ACC/AHA class IIa risk criteria, for whom "the use of ACE inhibitor or ARB is reasonable and should be initiated." Yet only 69.3% were discharged with an appropriate prescription: 64.7% received an ACE inhibitor prescription, 4.0% received an ARB prescription, and 0.6% received both.

In comparison, 98% of eligible patients were discharged on aspirin and 97% were discharged on beta-blockers, said Dr. Bainey of the Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, and his associates.

Appropriate prescription of ACE inhibitors and ARBs was "strikingly" low in patients who had undergone CABG during the hospitalization; such patients were 50% less likely than were others to receive the drugs, even though they were at much higher risk. This trend has been noted in previous studies and provides "further evidence of a persistent care gap that requires immediate attention," the investigators said (Circ. Cardiovasc. Qual. Outcomes 2014 Feb. 25 [doi:10.1161/circoutcomes.113.000422]).

"Another striking imbalance in ACE/ARB prescription" occurred in patients with a history of renal insufficiency, who were 40% less likely than were others to receive the drugs. It is possible that clinicians are hesitant to prescribe these medications because of concerns about worsening renal failure or potentiating hyperkalemia. But those risks are extremely low, and "current evidence clearly supports the use of renin-angiotensin system (RAS) inhibitor in halting the progression of chronic kidney disease," Dr. Bainey and his associates said.

The use of ACE inhibitors and ARBs has increased substantially over the past decade, coincident with the implementation of quality assurance initiatives such as GWTG-CAD. It was reassuring that this study showed an increase in use early in the study period. But it appears that this increase has plateaued, "which should prompt further hospital quality improvement and continued monitored adherence to secondary prevention guidelines," they added.

GWTG-CAD is an American Heart Association program and is supported in part by Merck/Schering-Plough and Pfizer. Dr. Bainey reported no financial conflicts of interest; his associates reported numerous ties to industry sources.

Fifteen percent of eligible patients treated for acute coronary syndrome still are not given ACE inhibitors or angiotensin receptor blockers as recommended, according to data from a quality improvement program. The results were published online Feb. 25 in Circulation: Cardiovascular Quality and Outcomes.

Prescription rates for ACE inhibitors and ARBs were lowest among certain patients who are at greatest risk of adverse outcomes if they don’t take the drugs: those who had coronary artery bypass graft (CABG) surgery to treat their ACS and those with a history of renal insufficiency. And the use of ACE inhibitors and ARBs was lower than that of other evidence-based therapies, such as aspirin and beta-blockers.

"Thus, ongoing quality improvement initiatives are still necessary to help ensure appropriate secondary prevention is delivered," said Dr. Kevin R. Bainey and his associates in the Get With The Guidelines–Coronary Artery Disease (GWTG-CAD) program, a quality improvement effort of the American Heart Association that includes a national registry of coronary artery disease hospitalizations.

To obtain current figures on adherence to guidelines regarding medication after ACS, Dr. Bainey and his colleagues reviewed the records of 80,241 patients admitted to 311 hospitals participating in GWTG program in 2005-2009. The researchers included patients who met American College of Cardiology/AHA class I or class IIa criteria for receiving ACE inhibitor or ARB therapy.

A total of 60,847 patients met ACC/AHA class I risk criteria, for whom it is "strongly recommended that an ACE inhibitor or ARB be started and continued indefinitely." Yet, at the end of the study period, only 85% were discharged with an appropriate prescription: 69.8% received an ACE inhibitor prescription, 13.5% received an ARB prescription, and 1.7% received both. Those rates were lower at the beginning of the period.

A total of 19,394 patients met ACC/AHA class IIa risk criteria, for whom "the use of ACE inhibitor or ARB is reasonable and should be initiated." Yet only 69.3% were discharged with an appropriate prescription: 64.7% received an ACE inhibitor prescription, 4.0% received an ARB prescription, and 0.6% received both.

In comparison, 98% of eligible patients were discharged on aspirin and 97% were discharged on beta-blockers, said Dr. Bainey of the Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, and his associates.

Appropriate prescription of ACE inhibitors and ARBs was "strikingly" low in patients who had undergone CABG during the hospitalization; such patients were 50% less likely than were others to receive the drugs, even though they were at much higher risk. This trend has been noted in previous studies and provides "further evidence of a persistent care gap that requires immediate attention," the investigators said (Circ. Cardiovasc. Qual. Outcomes 2014 Feb. 25 [doi:10.1161/circoutcomes.113.000422]).

"Another striking imbalance in ACE/ARB prescription" occurred in patients with a history of renal insufficiency, who were 40% less likely than were others to receive the drugs. It is possible that clinicians are hesitant to prescribe these medications because of concerns about worsening renal failure or potentiating hyperkalemia. But those risks are extremely low, and "current evidence clearly supports the use of renin-angiotensin system (RAS) inhibitor in halting the progression of chronic kidney disease," Dr. Bainey and his associates said.

The use of ACE inhibitors and ARBs has increased substantially over the past decade, coincident with the implementation of quality assurance initiatives such as GWTG-CAD. It was reassuring that this study showed an increase in use early in the study period. But it appears that this increase has plateaued, "which should prompt further hospital quality improvement and continued monitored adherence to secondary prevention guidelines," they added.

GWTG-CAD is an American Heart Association program and is supported in part by Merck/Schering-Plough and Pfizer. Dr. Bainey reported no financial conflicts of interest; his associates reported numerous ties to industry sources.

Current evidence is still insufficient to adequately assess whether taking vitamin supplements to prevent cardiovascular disease or cancer is beneficial or harmful, according to a recommendation statement issued by the U.S. Preventive Services Task Force and published online Feb. 24 in Annals of Internal Medicine.

This update of the 2003 USPSTF recommendation on vitamin supplementation to prevent CVD or cancer is based on a close review of 4 randomized controlled trials and 1 cohort study of multivitamins, as well as 24 studies of individual vitamins, minerals, or nutrient pairs. The USPSTF concluded that for the general adult population, there still isn’t enough evidence either for or against multivitamins, individual vitamins and minerals, or nutrient pairs. However, there are two exceptions: The task force clearly recommends against the use of beta-carotene and vitamin E as preventives, said Dr. Virginia A. Moyer, chair of the task force at the time this recommendation was finalized and a vice president of the American Board of Pediatrics, and her associates.

©Juanmonino/iStockphoto

The recommendation applies to healthy adults only, not to children, women who are pregnant or may become pregnant, or people who are hospitalized, have chronic illness, or have known nutritional deficiency.

The statement noted that the use of vitamin supplements is common among American adults, with annual sales reaching $28.1 billion in 2010. Many supplements are promoted as preventing heart disease and cancer, and industry-sponsored surveys indicate that many physicians and nurses recommend them to patients (Ann. Intern. Med. 2014 Feb. 24).

Like the USPSTF, the National Institutes of Health also has concluded that the evidence is insufficient to recommend for or against the use of multivitamins to prevent chronic disease. In addition, the Academy of Nutrition and Dietetics has stated that there is no evidence that vitamin supplements are effective at preventing chronic disease, and neither the American Cancer Society nor the American Institute for Cancer Research supports their use. The position of the American Heart Association and the American Academy of Family Physicians also is consistent with that of the USPSTF, Dr. Moyer and her associates said.

No financial conflicts of interest were reported.

Current evidence is still insufficient to adequately assess whether taking vitamin supplements to prevent cardiovascular disease or cancer is beneficial or harmful, according to a recommendation statement issued by the U.S. Preventive Services Task Force and published online Feb. 24 in Annals of Internal Medicine.

This update of the 2003 USPSTF recommendation on vitamin supplementation to prevent CVD or cancer is based on a close review of 4 randomized controlled trials and 1 cohort study of multivitamins, as well as 24 studies of individual vitamins, minerals, or nutrient pairs. The USPSTF concluded that for the general adult population, there still isn’t enough evidence either for or against multivitamins, individual vitamins and minerals, or nutrient pairs. However, there are two exceptions: The task force clearly recommends against the use of beta-carotene and vitamin E as preventives, said Dr. Virginia A. Moyer, chair of the task force at the time this recommendation was finalized and a vice president of the American Board of Pediatrics, and her associates.

©Juanmonino/iStockphoto

The recommendation applies to healthy adults only, not to children, women who are pregnant or may become pregnant, or people who are hospitalized, have chronic illness, or have known nutritional deficiency.

The statement noted that the use of vitamin supplements is common among American adults, with annual sales reaching $28.1 billion in 2010. Many supplements are promoted as preventing heart disease and cancer, and industry-sponsored surveys indicate that many physicians and nurses recommend them to patients (Ann. Intern. Med. 2014 Feb. 24).

Like the USPSTF, the National Institutes of Health also has concluded that the evidence is insufficient to recommend for or against the use of multivitamins to prevent chronic disease. In addition, the Academy of Nutrition and Dietetics has stated that there is no evidence that vitamin supplements are effective at preventing chronic disease, and neither the American Cancer Society nor the American Institute for Cancer Research supports their use. The position of the American Heart Association and the American Academy of Family Physicians also is consistent with that of the USPSTF, Dr. Moyer and her associates said.

No financial conflicts of interest were reported.

Current evidence is still insufficient to adequately assess whether taking vitamin supplements to prevent cardiovascular disease or cancer is beneficial or harmful, according to a recommendation statement issued by the U.S. Preventive Services Task Force and published online Feb. 24 in Annals of Internal Medicine.

This update of the 2003 USPSTF recommendation on vitamin supplementation to prevent CVD or cancer is based on a close review of 4 randomized controlled trials and 1 cohort study of multivitamins, as well as 24 studies of individual vitamins, minerals, or nutrient pairs. The USPSTF concluded that for the general adult population, there still isn’t enough evidence either for or against multivitamins, individual vitamins and minerals, or nutrient pairs. However, there are two exceptions: The task force clearly recommends against the use of beta-carotene and vitamin E as preventives, said Dr. Virginia A. Moyer, chair of the task force at the time this recommendation was finalized and a vice president of the American Board of Pediatrics, and her associates.

©Juanmonino/iStockphoto

The recommendation applies to healthy adults only, not to children, women who are pregnant or may become pregnant, or people who are hospitalized, have chronic illness, or have known nutritional deficiency.

The statement noted that the use of vitamin supplements is common among American adults, with annual sales reaching $28.1 billion in 2010. Many supplements are promoted as preventing heart disease and cancer, and industry-sponsored surveys indicate that many physicians and nurses recommend them to patients (Ann. Intern. Med. 2014 Feb. 24).

Like the USPSTF, the National Institutes of Health also has concluded that the evidence is insufficient to recommend for or against the use of multivitamins to prevent chronic disease. In addition, the Academy of Nutrition and Dietetics has stated that there is no evidence that vitamin supplements are effective at preventing chronic disease, and neither the American Cancer Society nor the American Institute for Cancer Research supports their use. The position of the American Heart Association and the American Academy of Family Physicians also is consistent with that of the USPSTF, Dr. Moyer and her associates said.

No financial conflicts of interest were reported.

The progression of disability in patients with multiple sclerosis was associated with whole brain, cortical, and putamen atrophy during the first 5 years after diagnosis, driven chiefly by a greater decline in gray matter than in white matter volume, according to a report published online in Journal of Neurology, Neurosurgery & Psychiatry.

To identify markers of disability progression in MS, researchers assessed 81 patients residing in Southwestern Norway who were diagnosed in 1998 or 2000 and underwent full neurologic assessments and brain MRI at that time, as well as 5 and 10 years later. Patients whose disability progressed, based on the Expanded Disability Status Scale, during follow-up were no different from those whose disability remained stable in demographic factors, MS subtype, or the use or duration of disease-modifying treatment, said Dr. Cecilie Jacobsen of the department of neurology at Stavanger (Norway) University Hospital and the Neuroimaging Analysis Center at the State University of New York at Buffalo, and her associates.

At 5 years, disease progression was associated with significantly greater volume declines in patients with disease than in those without in measurements of the whole brain (–3.8% vs. –2.0%), cortex (–3.4% vs. –1.8%), and putamen (–10.6% vs. –3.8%). However, at 10 years, there was only a nonsignificant trend toward decreased whole brain volume among patients with disease progression. The correlation was much stronger between disability progression and the decline in gray matter volume than it was between disability progression and the decline in white matter volume. "These findings strengthen the increasing evidence that [gray matter] pathology may be playing a crucial role in MS-related disability progression," the investigators wrote (J. Neurol. Neurosurg. Psychiatry 2014 Feb. 19 [doi:10.1136/jnnp-2013-306906]).

They cautioned that their study was limited by its relatively small sample size and by its "considerable" dropout rate (38%) through 10 years.

Dr. Jacobsen’s associates reported ties to numerous industry sources.

cnnews@frontlinemedcom.com

The progression of disability in patients with multiple sclerosis was associated with whole brain, cortical, and putamen atrophy during the first 5 years after diagnosis, driven chiefly by a greater decline in gray matter than in white matter volume, according to a report published online in Journal of Neurology, Neurosurgery & Psychiatry.

To identify markers of disability progression in MS, researchers assessed 81 patients residing in Southwestern Norway who were diagnosed in 1998 or 2000 and underwent full neurologic assessments and brain MRI at that time, as well as 5 and 10 years later. Patients whose disability progressed, based on the Expanded Disability Status Scale, during follow-up were no different from those whose disability remained stable in demographic factors, MS subtype, or the use or duration of disease-modifying treatment, said Dr. Cecilie Jacobsen of the department of neurology at Stavanger (Norway) University Hospital and the Neuroimaging Analysis Center at the State University of New York at Buffalo, and her associates.

At 5 years, disease progression was associated with significantly greater volume declines in patients with disease than in those without in measurements of the whole brain (–3.8% vs. –2.0%), cortex (–3.4% vs. –1.8%), and putamen (–10.6% vs. –3.8%). However, at 10 years, there was only a nonsignificant trend toward decreased whole brain volume among patients with disease progression. The correlation was much stronger between disability progression and the decline in gray matter volume than it was between disability progression and the decline in white matter volume. "These findings strengthen the increasing evidence that [gray matter] pathology may be playing a crucial role in MS-related disability progression," the investigators wrote (J. Neurol. Neurosurg. Psychiatry 2014 Feb. 19 [doi:10.1136/jnnp-2013-306906]).

They cautioned that their study was limited by its relatively small sample size and by its "considerable" dropout rate (38%) through 10 years.

Dr. Jacobsen’s associates reported ties to numerous industry sources.

cnnews@frontlinemedcom.com

The progression of disability in patients with multiple sclerosis was associated with whole brain, cortical, and putamen atrophy during the first 5 years after diagnosis, driven chiefly by a greater decline in gray matter than in white matter volume, according to a report published online in Journal of Neurology, Neurosurgery & Psychiatry.

To identify markers of disability progression in MS, researchers assessed 81 patients residing in Southwestern Norway who were diagnosed in 1998 or 2000 and underwent full neurologic assessments and brain MRI at that time, as well as 5 and 10 years later. Patients whose disability progressed, based on the Expanded Disability Status Scale, during follow-up were no different from those whose disability remained stable in demographic factors, MS subtype, or the use or duration of disease-modifying treatment, said Dr. Cecilie Jacobsen of the department of neurology at Stavanger (Norway) University Hospital and the Neuroimaging Analysis Center at the State University of New York at Buffalo, and her associates.

At 5 years, disease progression was associated with significantly greater volume declines in patients with disease than in those without in measurements of the whole brain (–3.8% vs. –2.0%), cortex (–3.4% vs. –1.8%), and putamen (–10.6% vs. –3.8%). However, at 10 years, there was only a nonsignificant trend toward decreased whole brain volume among patients with disease progression. The correlation was much stronger between disability progression and the decline in gray matter volume than it was between disability progression and the decline in white matter volume. "These findings strengthen the increasing evidence that [gray matter] pathology may be playing a crucial role in MS-related disability progression," the investigators wrote (J. Neurol. Neurosurg. Psychiatry 2014 Feb. 19 [doi:10.1136/jnnp-2013-306906]).

They cautioned that their study was limited by its relatively small sample size and by its "considerable" dropout rate (38%) through 10 years.

Dr. Jacobsen’s associates reported ties to numerous industry sources.

cnnews@frontlinemedcom.com

Among Dutch children with tympanostomy tubes who developed acute otorrhea, eardrops containing an antibiotic and glucocorticoid were more effective than oral antibiotics and much more effective than observation only at clearing the otorrhea in an open-label clinical trial, investigators reported online Feb. 19 in the New England Journal of Medicine.

In addition, the median duration of that episode of otorrhea was shorter, the median number of days with otorrhea during the next 6 months was much lower, and the median number of recurrences of otorrhea during the next 6 months was smaller with the eardrops. Disease-specific and health-related quality of life scores also "consistently favored eardrops," reported Dr. Thijs M.A. van Dongen of the epidemiology department, Julius Center for Health Sciences and Primary Care, University of Utrecht (the Netherlands) Medical Center, and his associates.

The findings suggest that observation only "may not be an adequate management strategy in such children," they noted.

The eardrops used in this study (Bacicoline-B, manufactured by Daleco Pharma) contain hydrocortisone, bacitracin, and colistin, and are active against most bacteria that cause acute tympanostomy-tube otorrhea, such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. But the eardrops "are not routinely available outside the Netherlands and France."

Although there is no evidence yet to support this opinion, "we believe that any combination of antibiotic-glucocorticoid eardrops with similar antimicrobial activity, such as ciprofloxacin and dexamethasone, would be likely to have similar results," Dr. van Dongen and his colleagues wrote.

The researchers compared the three management strategies during a 3-year period in 230 children aged 1-10 years who were referred to the trial by ear, nose, and throat surgeons and family physicians. The mean age of the participants was 4.5 years, and the median duration of otorrhea before entry into the study was 3 days.

The children were randomly assigned to receive either five eardrops three times per day for 1 week in the discharging ear or ears (76 patients), oral amoxicillin-clavulanate suspension divided into three daily doses for 1 week (77 patients), or observation only for 2 weeks (77 patients). The children in group 2 received the dose recommended in the Netherlands and other countries in Europe, where resistance rates are low: 30 mg of amoxicillin and 7.5 mg of clavulanate per kilogram per day.

The first follow-up visit was scheduled at 2 weeks, with a final follow-up for complications and ear-related symptoms at 6 months.

The primary outcome measure – treatment failure, defined as the presence of otorrhea in one or both ears at 2 weeks – occurred in 5% of the eardrop group, 44% of the oral antibiotic group, and 55% of the observation-only group, the investigators said (N. Engl. J. Med. 2014;370:723-33).

The median duration of the index episode of otorrhea was 4 days for children who received eardrops, 5 days for those who received oral antibiotics, and 12 days for those assigned to observation only.

The median number of days with otorrhea during follow-up was 5 days for the eardrop group, 13.5 days for the oral antibiotic group, and 18 days for the observation-only group. Children treated with eardrops had no recurrences of otorrhea during follow-up; children in the other two groups had a median of 1 recurrence each within that 6-month period.

Scores on measures of disease-specific health-related quality of life improved slightly but significantly in the eardrop group, compared with the other study groups.

No serious complications of otitis media occurred, such as local cellulitis, perichondritis, mastoiditis, or intracranial abnormalities. Eighteen children who received oral antibiotics (23% of that group) developed gastrointestinal symptoms, and 3 (4%) developed rash.

The investigators noted that when designing this trial, they assumed that an absolute reduction of 20 percentage points in the incidence of otorrhea at 2 weeks would be necessary to show that one of the management strategies was superior to the others in a clinically relevant way. In the event, the reduction in risk was actually twice as large, "showing the importance of our findings for clinical practice," they said.

Dr. van Dongen and his associates added, "We believe our findings are applicable to children with uncomplicated acute tympanostomy-tube otorrhea presenting in either primary or secondary care."

This study was supported by the Netherlands Organization for Health Research and Development. Dr. van Dongen reported no financial conflicts of interest; one of his associates reported receiving grants from GlaxoSmithKline.

Among Dutch children with tympanostomy tubes who developed acute otorrhea, eardrops containing an antibiotic and glucocorticoid were more effective than oral antibiotics and much more effective than observation only at clearing the otorrhea in an open-label clinical trial, investigators reported online Feb. 19 in the New England Journal of Medicine.

In addition, the median duration of that episode of otorrhea was shorter, the median number of days with otorrhea during the next 6 months was much lower, and the median number of recurrences of otorrhea during the next 6 months was smaller with the eardrops. Disease-specific and health-related quality of life scores also "consistently favored eardrops," reported Dr. Thijs M.A. van Dongen of the epidemiology department, Julius Center for Health Sciences and Primary Care, University of Utrecht (the Netherlands) Medical Center, and his associates.

The findings suggest that observation only "may not be an adequate management strategy in such children," they noted.

The eardrops used in this study (Bacicoline-B, manufactured by Daleco Pharma) contain hydrocortisone, bacitracin, and colistin, and are active against most bacteria that cause acute tympanostomy-tube otorrhea, such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. But the eardrops "are not routinely available outside the Netherlands and France."

Although there is no evidence yet to support this opinion, "we believe that any combination of antibiotic-glucocorticoid eardrops with similar antimicrobial activity, such as ciprofloxacin and dexamethasone, would be likely to have similar results," Dr. van Dongen and his colleagues wrote.

The researchers compared the three management strategies during a 3-year period in 230 children aged 1-10 years who were referred to the trial by ear, nose, and throat surgeons and family physicians. The mean age of the participants was 4.5 years, and the median duration of otorrhea before entry into the study was 3 days.

The children were randomly assigned to receive either five eardrops three times per day for 1 week in the discharging ear or ears (76 patients), oral amoxicillin-clavulanate suspension divided into three daily doses for 1 week (77 patients), or observation only for 2 weeks (77 patients). The children in group 2 received the dose recommended in the Netherlands and other countries in Europe, where resistance rates are low: 30 mg of amoxicillin and 7.5 mg of clavulanate per kilogram per day.

The first follow-up visit was scheduled at 2 weeks, with a final follow-up for complications and ear-related symptoms at 6 months.

The primary outcome measure – treatment failure, defined as the presence of otorrhea in one or both ears at 2 weeks – occurred in 5% of the eardrop group, 44% of the oral antibiotic group, and 55% of the observation-only group, the investigators said (N. Engl. J. Med. 2014;370:723-33).

The median duration of the index episode of otorrhea was 4 days for children who received eardrops, 5 days for those who received oral antibiotics, and 12 days for those assigned to observation only.

The median number of days with otorrhea during follow-up was 5 days for the eardrop group, 13.5 days for the oral antibiotic group, and 18 days for the observation-only group. Children treated with eardrops had no recurrences of otorrhea during follow-up; children in the other two groups had a median of 1 recurrence each within that 6-month period.

Scores on measures of disease-specific health-related quality of life improved slightly but significantly in the eardrop group, compared with the other study groups.

No serious complications of otitis media occurred, such as local cellulitis, perichondritis, mastoiditis, or intracranial abnormalities. Eighteen children who received oral antibiotics (23% of that group) developed gastrointestinal symptoms, and 3 (4%) developed rash.

The investigators noted that when designing this trial, they assumed that an absolute reduction of 20 percentage points in the incidence of otorrhea at 2 weeks would be necessary to show that one of the management strategies was superior to the others in a clinically relevant way. In the event, the reduction in risk was actually twice as large, "showing the importance of our findings for clinical practice," they said.

Dr. van Dongen and his associates added, "We believe our findings are applicable to children with uncomplicated acute tympanostomy-tube otorrhea presenting in either primary or secondary care."

This study was supported by the Netherlands Organization for Health Research and Development. Dr. van Dongen reported no financial conflicts of interest; one of his associates reported receiving grants from GlaxoSmithKline.

Among Dutch children with tympanostomy tubes who developed acute otorrhea, eardrops containing an antibiotic and glucocorticoid were more effective than oral antibiotics and much more effective than observation only at clearing the otorrhea in an open-label clinical trial, investigators reported online Feb. 19 in the New England Journal of Medicine.

In addition, the median duration of that episode of otorrhea was shorter, the median number of days with otorrhea during the next 6 months was much lower, and the median number of recurrences of otorrhea during the next 6 months was smaller with the eardrops. Disease-specific and health-related quality of life scores also "consistently favored eardrops," reported Dr. Thijs M.A. van Dongen of the epidemiology department, Julius Center for Health Sciences and Primary Care, University of Utrecht (the Netherlands) Medical Center, and his associates.

The findings suggest that observation only "may not be an adequate management strategy in such children," they noted.

The eardrops used in this study (Bacicoline-B, manufactured by Daleco Pharma) contain hydrocortisone, bacitracin, and colistin, and are active against most bacteria that cause acute tympanostomy-tube otorrhea, such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. But the eardrops "are not routinely available outside the Netherlands and France."

Although there is no evidence yet to support this opinion, "we believe that any combination of antibiotic-glucocorticoid eardrops with similar antimicrobial activity, such as ciprofloxacin and dexamethasone, would be likely to have similar results," Dr. van Dongen and his colleagues wrote.

The researchers compared the three management strategies during a 3-year period in 230 children aged 1-10 years who were referred to the trial by ear, nose, and throat surgeons and family physicians. The mean age of the participants was 4.5 years, and the median duration of otorrhea before entry into the study was 3 days.

The children were randomly assigned to receive either five eardrops three times per day for 1 week in the discharging ear or ears (76 patients), oral amoxicillin-clavulanate suspension divided into three daily doses for 1 week (77 patients), or observation only for 2 weeks (77 patients). The children in group 2 received the dose recommended in the Netherlands and other countries in Europe, where resistance rates are low: 30 mg of amoxicillin and 7.5 mg of clavulanate per kilogram per day.

The first follow-up visit was scheduled at 2 weeks, with a final follow-up for complications and ear-related symptoms at 6 months.

The primary outcome measure – treatment failure, defined as the presence of otorrhea in one or both ears at 2 weeks – occurred in 5% of the eardrop group, 44% of the oral antibiotic group, and 55% of the observation-only group, the investigators said (N. Engl. J. Med. 2014;370:723-33).

The median duration of the index episode of otorrhea was 4 days for children who received eardrops, 5 days for those who received oral antibiotics, and 12 days for those assigned to observation only.

The median number of days with otorrhea during follow-up was 5 days for the eardrop group, 13.5 days for the oral antibiotic group, and 18 days for the observation-only group. Children treated with eardrops had no recurrences of otorrhea during follow-up; children in the other two groups had a median of 1 recurrence each within that 6-month period.

Scores on measures of disease-specific health-related quality of life improved slightly but significantly in the eardrop group, compared with the other study groups.

No serious complications of otitis media occurred, such as local cellulitis, perichondritis, mastoiditis, or intracranial abnormalities. Eighteen children who received oral antibiotics (23% of that group) developed gastrointestinal symptoms, and 3 (4%) developed rash.

The investigators noted that when designing this trial, they assumed that an absolute reduction of 20 percentage points in the incidence of otorrhea at 2 weeks would be necessary to show that one of the management strategies was superior to the others in a clinically relevant way. In the event, the reduction in risk was actually twice as large, "showing the importance of our findings for clinical practice," they said.

Dr. van Dongen and his associates added, "We believe our findings are applicable to children with uncomplicated acute tympanostomy-tube otorrhea presenting in either primary or secondary care."

This study was supported by the Netherlands Organization for Health Research and Development. Dr. van Dongen reported no financial conflicts of interest; one of his associates reported receiving grants from GlaxoSmithKline.

Video interventions on the importance of undergoing clinical skin examinations may increase melanoma discovery rates, according to the results of a randomized clinical trial published online Feb. 19 in JAMA Dermatology.

A total of 870 Australian men aged 50 and older were randomly assigned to receive either a video plus written educational materials (436 men in the intervention group) or only the educational materials (434 men in the control group). Six months later, 35.3% of the intervention group patients reported that they had received a whole-body clinical skin examination from a physician during the interim, compared with 27.2% of the control group, the investigators reported (JAMA Dermatol. 2014 Feb. 19 [doi:10.1001/jamadermatol.2013.9313]).

The video emphasized the seriousness of a melanoma diagnosis, explained risk factors for the disease and stressed the increased risk for men over age 50, modeled a whole-body self-examination, and showed a melanoma surgeon encouraging people to do their own skin exams and to request them from their physicians. The video also demonstrated a clinical skin exam being performed by a physician, and featured a well-known athlete, as well as melanoma survivors, who encouraged men to be screened for skin cancer, according to Monika Janda, Ph.D., of the School of Public Health and Biomedical Innovation, Queensland University of Technology, Brisbane, and her associates.

Overall, 34.1% of the intervention group underwent surgical excision or biopsy of at least 1 skin lesion, compared with 27.1% of the control group. Of the 130 lesions for which pathology reports were available, 2 were melanomas, 29 were squamous cell carcinomas, 38 were basal cell carcinomas, 17 were solar keratoses, 9 were benign nevi, 3 were dysplatic nevi, and 32 were other lesions. Significantly more skin cancers were detected in the intervention group (60%) than in the control group (40%), suggesting that the video intervention may lead to earlier detection of melanoma and other skin malignancies, Dr. Janda and her associates concluded.

This study was funded by the Australian National Health and Medical Research Committee. No financial conflicts of interest were reported.

Video interventions on the importance of undergoing clinical skin examinations may increase melanoma discovery rates, according to the results of a randomized clinical trial published online Feb. 19 in JAMA Dermatology.

A total of 870 Australian men aged 50 and older were randomly assigned to receive either a video plus written educational materials (436 men in the intervention group) or only the educational materials (434 men in the control group). Six months later, 35.3% of the intervention group patients reported that they had received a whole-body clinical skin examination from a physician during the interim, compared with 27.2% of the control group, the investigators reported (JAMA Dermatol. 2014 Feb. 19 [doi:10.1001/jamadermatol.2013.9313]).

The video emphasized the seriousness of a melanoma diagnosis, explained risk factors for the disease and stressed the increased risk for men over age 50, modeled a whole-body self-examination, and showed a melanoma surgeon encouraging people to do their own skin exams and to request them from their physicians. The video also demonstrated a clinical skin exam being performed by a physician, and featured a well-known athlete, as well as melanoma survivors, who encouraged men to be screened for skin cancer, according to Monika Janda, Ph.D., of the School of Public Health and Biomedical Innovation, Queensland University of Technology, Brisbane, and her associates.

Overall, 34.1% of the intervention group underwent surgical excision or biopsy of at least 1 skin lesion, compared with 27.1% of the control group. Of the 130 lesions for which pathology reports were available, 2 were melanomas, 29 were squamous cell carcinomas, 38 were basal cell carcinomas, 17 were solar keratoses, 9 were benign nevi, 3 were dysplatic nevi, and 32 were other lesions. Significantly more skin cancers were detected in the intervention group (60%) than in the control group (40%), suggesting that the video intervention may lead to earlier detection of melanoma and other skin malignancies, Dr. Janda and her associates concluded.

This study was funded by the Australian National Health and Medical Research Committee. No financial conflicts of interest were reported.

Video interventions on the importance of undergoing clinical skin examinations may increase melanoma discovery rates, according to the results of a randomized clinical trial published online Feb. 19 in JAMA Dermatology.

A total of 870 Australian men aged 50 and older were randomly assigned to receive either a video plus written educational materials (436 men in the intervention group) or only the educational materials (434 men in the control group). Six months later, 35.3% of the intervention group patients reported that they had received a whole-body clinical skin examination from a physician during the interim, compared with 27.2% of the control group, the investigators reported (JAMA Dermatol. 2014 Feb. 19 [doi:10.1001/jamadermatol.2013.9313]).

The video emphasized the seriousness of a melanoma diagnosis, explained risk factors for the disease and stressed the increased risk for men over age 50, modeled a whole-body self-examination, and showed a melanoma surgeon encouraging people to do their own skin exams and to request them from their physicians. The video also demonstrated a clinical skin exam being performed by a physician, and featured a well-known athlete, as well as melanoma survivors, who encouraged men to be screened for skin cancer, according to Monika Janda, Ph.D., of the School of Public Health and Biomedical Innovation, Queensland University of Technology, Brisbane, and her associates.

Overall, 34.1% of the intervention group underwent surgical excision or biopsy of at least 1 skin lesion, compared with 27.1% of the control group. Of the 130 lesions for which pathology reports were available, 2 were melanomas, 29 were squamous cell carcinomas, 38 were basal cell carcinomas, 17 were solar keratoses, 9 were benign nevi, 3 were dysplatic nevi, and 32 were other lesions. Significantly more skin cancers were detected in the intervention group (60%) than in the control group (40%), suggesting that the video intervention may lead to earlier detection of melanoma and other skin malignancies, Dr. Janda and her associates concluded.

This study was funded by the Australian National Health and Medical Research Committee. No financial conflicts of interest were reported.

Statewide health care reform in Massachusetts did not increase inpatient admissions for behavioral diagnoses among adolescents and young adults, as some had feared. Instead, reform led to a decrease in such admissions, a report published online Feb. 19 in JAMA Psychiatry showed.

This suggests nationwide health care reform might have a similar effect, at least in states that, like Massachusetts, offer robust hospital-based mental health services.

©AndreyPopov/thinkstockphotos.com

One major goal of health care reform is to extend insurance coverage to populations least likely to have it, such as young adults. Given that most behavioral health disorders emerge in adolescence and young adulthood, some experts were concerned that newly acquired insurance coverage for this age group might lead to increases in hospital and emergency department admissions for behavioral issues, said Ellen Meara, Ph.D., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., and her associates.

To assess whether the enactment of national health care reform might lead to a sharp increase in such hospital and ED admissions, the investigators examined the experience in Massachusetts after statewide health care reform was enacted there in 2006.

They analyzed the records of 2,533,307 admissions for any diagnosis and 6,817,855 ED visits for any diagnosis and focused on young adults aged 19-25 years – "a group with relatively high behavioral health needs and low rates of insurance coverage prior to reform" (JAMA Psychiatry 2014 Feb. 19 [doi:10.1001/jamapsychiatry.2013.3972]).

Dr. Meara and her associates found that the uninsured rate fell from 26% to 10% among this population after health reform. The increase in insurance coverage was accompanied by a decline in patient admission rates and ED visits for young adults with behavioral health diagnoses. The drop was fueled primarily by a decrease in admissions and ED visits for substance use disorders. This pattern suggests that most of these patients are being redirected – appropriately – to outpatient services, Dr. Meara and her associates said.

The findings are reassuring in that they appear to show that young people with behavioral health issues will now find the care they need to be more accessible and affordable, without increasing the burden on hospitals or raising inpatient costs, they said.

Dr. Meara and her associates cited a few limitations. For example, outpatient treatment for mental illness or substance use disorders was not observed. "Thus, we cannot infer whether use of hospital-based care for mental illness and substance use disorders represents lower rates of morbidity in the population, effective care in outpatient settings, or restrictions on use of hospital-based settings," they wrote. In addition, they did not look at admissions to psychiatric or alcohol or chemical-dependency facilities.

Still, the data "offer a snapshot of one aspect of policies to improve access to behavioral health treatment, expanded insurance coverage," they said.

The study was supported by the National Institutes of Health and the National Institute of Drug Abuse. No financial conflicts of interest were reported.

Statewide health care reform in Massachusetts did not increase inpatient admissions for behavioral diagnoses among adolescents and young adults, as some had feared. Instead, reform led to a decrease in such admissions, a report published online Feb. 19 in JAMA Psychiatry showed.

This suggests nationwide health care reform might have a similar effect, at least in states that, like Massachusetts, offer robust hospital-based mental health services.

©AndreyPopov/thinkstockphotos.com

One major goal of health care reform is to extend insurance coverage to populations least likely to have it, such as young adults. Given that most behavioral health disorders emerge in adolescence and young adulthood, some experts were concerned that newly acquired insurance coverage for this age group might lead to increases in hospital and emergency department admissions for behavioral issues, said Ellen Meara, Ph.D., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., and her associates.

To assess whether the enactment of national health care reform might lead to a sharp increase in such hospital and ED admissions, the investigators examined the experience in Massachusetts after statewide health care reform was enacted there in 2006.

They analyzed the records of 2,533,307 admissions for any diagnosis and 6,817,855 ED visits for any diagnosis and focused on young adults aged 19-25 years – "a group with relatively high behavioral health needs and low rates of insurance coverage prior to reform" (JAMA Psychiatry 2014 Feb. 19 [doi:10.1001/jamapsychiatry.2013.3972]).

Dr. Meara and her associates found that the uninsured rate fell from 26% to 10% among this population after health reform. The increase in insurance coverage was accompanied by a decline in patient admission rates and ED visits for young adults with behavioral health diagnoses. The drop was fueled primarily by a decrease in admissions and ED visits for substance use disorders. This pattern suggests that most of these patients are being redirected – appropriately – to outpatient services, Dr. Meara and her associates said.

The findings are reassuring in that they appear to show that young people with behavioral health issues will now find the care they need to be more accessible and affordable, without increasing the burden on hospitals or raising inpatient costs, they said.

Dr. Meara and her associates cited a few limitations. For example, outpatient treatment for mental illness or substance use disorders was not observed. "Thus, we cannot infer whether use of hospital-based care for mental illness and substance use disorders represents lower rates of morbidity in the population, effective care in outpatient settings, or restrictions on use of hospital-based settings," they wrote. In addition, they did not look at admissions to psychiatric or alcohol or chemical-dependency facilities.

Still, the data "offer a snapshot of one aspect of policies to improve access to behavioral health treatment, expanded insurance coverage," they said.

The study was supported by the National Institutes of Health and the National Institute of Drug Abuse. No financial conflicts of interest were reported.

Statewide health care reform in Massachusetts did not increase inpatient admissions for behavioral diagnoses among adolescents and young adults, as some had feared. Instead, reform led to a decrease in such admissions, a report published online Feb. 19 in JAMA Psychiatry showed.

This suggests nationwide health care reform might have a similar effect, at least in states that, like Massachusetts, offer robust hospital-based mental health services.

©AndreyPopov/thinkstockphotos.com

One major goal of health care reform is to extend insurance coverage to populations least likely to have it, such as young adults. Given that most behavioral health disorders emerge in adolescence and young adulthood, some experts were concerned that newly acquired insurance coverage for this age group might lead to increases in hospital and emergency department admissions for behavioral issues, said Ellen Meara, Ph.D., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., and her associates.

To assess whether the enactment of national health care reform might lead to a sharp increase in such hospital and ED admissions, the investigators examined the experience in Massachusetts after statewide health care reform was enacted there in 2006.

They analyzed the records of 2,533,307 admissions for any diagnosis and 6,817,855 ED visits for any diagnosis and focused on young adults aged 19-25 years – "a group with relatively high behavioral health needs and low rates of insurance coverage prior to reform" (JAMA Psychiatry 2014 Feb. 19 [doi:10.1001/jamapsychiatry.2013.3972]).

Dr. Meara and her associates found that the uninsured rate fell from 26% to 10% among this population after health reform. The increase in insurance coverage was accompanied by a decline in patient admission rates and ED visits for young adults with behavioral health diagnoses. The drop was fueled primarily by a decrease in admissions and ED visits for substance use disorders. This pattern suggests that most of these patients are being redirected – appropriately – to outpatient services, Dr. Meara and her associates said.

The findings are reassuring in that they appear to show that young people with behavioral health issues will now find the care they need to be more accessible and affordable, without increasing the burden on hospitals or raising inpatient costs, they said.

Dr. Meara and her associates cited a few limitations. For example, outpatient treatment for mental illness or substance use disorders was not observed. "Thus, we cannot infer whether use of hospital-based care for mental illness and substance use disorders represents lower rates of morbidity in the population, effective care in outpatient settings, or restrictions on use of hospital-based settings," they wrote. In addition, they did not look at admissions to psychiatric or alcohol or chemical-dependency facilities.

Still, the data "offer a snapshot of one aspect of policies to improve access to behavioral health treatment, expanded insurance coverage," they said.

The study was supported by the National Institutes of Health and the National Institute of Drug Abuse. No financial conflicts of interest were reported.

Among younger patients with treatment-naive paroxysmal atrial fibrillation, radiofrequency ablation modestly lowered the rate of recurrent atrial tachyarrhythmia during 2 years of follow-up, compared with medical therapy, according to a report published online Feb. 18 in JAMA.

"Ablation extends the time free of both symptomatic and asymptomatic AF and significantly reduced the recurrence of repeated episodes, potentially having an effect on AF progression." However, recurrent AF was documented in nearly half of the patients who underwent ablation, and quality of life was improved to the same degree in both groups, said Dr. Carlos A. Morillo of the Population Health Research Institute, McMaster University, Hamilton (Ont.), and his associates.

The investigators conducted the second Radiofrequency Ablation vs. Antiarrhythmic Drugs as First-Line Therapy of Atrial Fibrillation (RAAFT-2) clinical trial to examine whether ablation is superior to drugs as first-line therapy for patients with treatment-naive paroxysmal AF. Over the course of 4 years, the 127 study subjects (mean age, 55 years) were treated and followed at 16 medical centers in North America and Europe.

These participants were randomly assigned to undergo ablation (66 patients) or receive antiarrhythmic medications (61 patients) and were monitored by telephone biweekly, as well as every time they experienced symptoms, for 2 years.

Recurrence of any atrial tachyarrhythmia lasting longer than 30 seconds was documented in 36 patients in the ablation group (54.5%), compared with 44 in the medication group (72.1%). In addition, asymptomatic AF occurred in 6 patients in the ablation group (9%), compared with 11 in the medication group (18%).

Symptomatic recurrence of AF, atrial flutter, or atrial tachyarrhythmia occurred in 31 patients in the ablation group (47%), compared with 36 in the medication group (59%). And the rate of multiple recurrences of symptomatic or asymptomatic atrial tachyarrhythmia also favored ablation over medication, Dr. Morillo and his associates said (JAMA 2014 Feb. 18;311:692-9 [doi:10.1001/jama.2014.467]).

At baseline, quality of life was moderately impaired in both groups as measured by the EQ-5D. In both groups, it improved to roughly the same degree and normalized at 1 year.

The most frequent major complication in the ablation group was cardiac tamponade, which developed in 6% of patients. Severe pulmonary vein stenosis developed in 1.5%, and bradycardia requiring placement of a permanent pacemaker developed in 1.5%. "This highlights the fact that ablation carries considerable risks that need to be discussed with the patient when offering it as a therapeutic alternative to patients who have not yet taken antiarrhythmic drugs," the investigators noted.

They added that their study sample was relatively small and the treatment effect, though statistically significant, "may be clinically modest." Moreover, "the risks of ablation were not negligible," Dr. Morillo and his colleagues said.

Among younger patients with treatment-naive paroxysmal atrial fibrillation, radiofrequency ablation modestly lowered the rate of recurrent atrial tachyarrhythmia during 2 years of follow-up, compared with medical therapy, according to a report published online Feb. 18 in JAMA.

"Ablation extends the time free of both symptomatic and asymptomatic AF and significantly reduced the recurrence of repeated episodes, potentially having an effect on AF progression." However, recurrent AF was documented in nearly half of the patients who underwent ablation, and quality of life was improved to the same degree in both groups, said Dr. Carlos A. Morillo of the Population Health Research Institute, McMaster University, Hamilton (Ont.), and his associates.

The investigators conducted the second Radiofrequency Ablation vs. Antiarrhythmic Drugs as First-Line Therapy of Atrial Fibrillation (RAAFT-2) clinical trial to examine whether ablation is superior to drugs as first-line therapy for patients with treatment-naive paroxysmal AF. Over the course of 4 years, the 127 study subjects (mean age, 55 years) were treated and followed at 16 medical centers in North America and Europe.

These participants were randomly assigned to undergo ablation (66 patients) or receive antiarrhythmic medications (61 patients) and were monitored by telephone biweekly, as well as every time they experienced symptoms, for 2 years.

Recurrence of any atrial tachyarrhythmia lasting longer than 30 seconds was documented in 36 patients in the ablation group (54.5%), compared with 44 in the medication group (72.1%). In addition, asymptomatic AF occurred in 6 patients in the ablation group (9%), compared with 11 in the medication group (18%).

Symptomatic recurrence of AF, atrial flutter, or atrial tachyarrhythmia occurred in 31 patients in the ablation group (47%), compared with 36 in the medication group (59%). And the rate of multiple recurrences of symptomatic or asymptomatic atrial tachyarrhythmia also favored ablation over medication, Dr. Morillo and his associates said (JAMA 2014 Feb. 18;311:692-9 [doi:10.1001/jama.2014.467]).

At baseline, quality of life was moderately impaired in both groups as measured by the EQ-5D. In both groups, it improved to roughly the same degree and normalized at 1 year.

The most frequent major complication in the ablation group was cardiac tamponade, which developed in 6% of patients. Severe pulmonary vein stenosis developed in 1.5%, and bradycardia requiring placement of a permanent pacemaker developed in 1.5%. "This highlights the fact that ablation carries considerable risks that need to be discussed with the patient when offering it as a therapeutic alternative to patients who have not yet taken antiarrhythmic drugs," the investigators noted.

They added that their study sample was relatively small and the treatment effect, though statistically significant, "may be clinically modest." Moreover, "the risks of ablation were not negligible," Dr. Morillo and his colleagues said.

Among younger patients with treatment-naive paroxysmal atrial fibrillation, radiofrequency ablation modestly lowered the rate of recurrent atrial tachyarrhythmia during 2 years of follow-up, compared with medical therapy, according to a report published online Feb. 18 in JAMA.

"Ablation extends the time free of both symptomatic and asymptomatic AF and significantly reduced the recurrence of repeated episodes, potentially having an effect on AF progression." However, recurrent AF was documented in nearly half of the patients who underwent ablation, and quality of life was improved to the same degree in both groups, said Dr. Carlos A. Morillo of the Population Health Research Institute, McMaster University, Hamilton (Ont.), and his associates.

The investigators conducted the second Radiofrequency Ablation vs. Antiarrhythmic Drugs as First-Line Therapy of Atrial Fibrillation (RAAFT-2) clinical trial to examine whether ablation is superior to drugs as first-line therapy for patients with treatment-naive paroxysmal AF. Over the course of 4 years, the 127 study subjects (mean age, 55 years) were treated and followed at 16 medical centers in North America and Europe.

These participants were randomly assigned to undergo ablation (66 patients) or receive antiarrhythmic medications (61 patients) and were monitored by telephone biweekly, as well as every time they experienced symptoms, for 2 years.

Recurrence of any atrial tachyarrhythmia lasting longer than 30 seconds was documented in 36 patients in the ablation group (54.5%), compared with 44 in the medication group (72.1%). In addition, asymptomatic AF occurred in 6 patients in the ablation group (9%), compared with 11 in the medication group (18%).

Symptomatic recurrence of AF, atrial flutter, or atrial tachyarrhythmia occurred in 31 patients in the ablation group (47%), compared with 36 in the medication group (59%). And the rate of multiple recurrences of symptomatic or asymptomatic atrial tachyarrhythmia also favored ablation over medication, Dr. Morillo and his associates said (JAMA 2014 Feb. 18;311:692-9 [doi:10.1001/jama.2014.467]).

At baseline, quality of life was moderately impaired in both groups as measured by the EQ-5D. In both groups, it improved to roughly the same degree and normalized at 1 year.

The most frequent major complication in the ablation group was cardiac tamponade, which developed in 6% of patients. Severe pulmonary vein stenosis developed in 1.5%, and bradycardia requiring placement of a permanent pacemaker developed in 1.5%. "This highlights the fact that ablation carries considerable risks that need to be discussed with the patient when offering it as a therapeutic alternative to patients who have not yet taken antiarrhythmic drugs," the investigators noted.

They added that their study sample was relatively small and the treatment effect, though statistically significant, "may be clinically modest." Moreover, "the risks of ablation were not negligible," Dr. Morillo and his colleagues said.

Daily oral citalopram improved agitation in patients with Alzheimer’s disease and reduced caregiver stress but was associated with a higher rate of cardiac adverse effects than was placebo at the dose used in a multicenter, double-blind, randomized trial.

This benefit was of "clinically meaningful" magnitude and comparable to that reported for treatment with antipsychotic drugs. In addition, 40% of the study participants who received citalopram were deemed to be much or very much improved on a measure of clinically significant change in agitation, compared with 26% of those who received placebo, Dr. Anton P. Porsteinsson of the department of psychiatry at the University of Rochester (N.Y.) and his associates reported Feb. 18 in JAMA.

Cognitive decline, however, was slightly greater with citalopram than with placebo, and the active treatment was associated with QT-interval prolongation. These adverse effects are concerning, so citalopram, at least at the 30-mg daily dose used in this trial, "cannot be generally recommended as an alternative treatment option," the investigators said.

Citalopram, a selective serotonin reuptake inhibitor (SSRI), has been proposed as a safer alternative to antipsychotic drugs for agitation and aggression in dementia patients, even though until now there has only been limited evidence supporting its safety and efficacy. Dr. Porsteinsson and his colleagues conducted the Citalopram for Agitation in Alzheimer Disease (CitAD) study at eight U.S. and Canadian academic medical centers to further test the drug’s safety and efficacy in 186 AD patients who had significant agitation but no depression.

The average age of these study participants was 78 years; 46% were women, 65% were white and non-Hispanic, and 89% were community dwelling. All had dementia of at least 5 years’ duration. Approximately two-thirds took cholinesterase inhibitors and 42% took memantine (Namenda). All were allowed to receive lorazepam or trazodone as rescue medications for significant agitation or sleep disturbance.

A total of 94 patients were randomly assigned to receive 30 mg oral citalopram daily and 92 to receive a matching placebo in a double-blind fashion for 9 weeks. All the participants and their caregivers also received psychosocial support in the form of educational materials; 24-hour crisis management; a supportive-care plan; and 20- to 30-minute counseling sessions during study visits for individualized emotional support, skill building, and problem solving (JAMA 2014;311:682-91).

The trial took place between 2009 and 2013. Midway through in 2011, the U.S. Food and Drug Administration published an advisory that warned of a dose-dependent risk of QT prolongation with citalopram. The CitAD protocol was then amended to exclude participants with high QTc, to include ECG exams for all future participants, and to add serum magnesium to routine electrolyte monitoring.

The primary outcome measures were scores on the agitation subscale of the Neurobehavioral Rating Scale (NBRS-A) – which assesses agitation, hostility/uncooperativeness, and disinhibition – and scores on a modified version of the Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale. Participants receiving citalopram showed significant improvement on the NBRS-A, compared with those receiving placebo. Overall, 40% of the citalopram group, compared with only 26% of the placebo group, showed moderate to marked improvement on ADCS-CGIC scores.

Citalopram also offered significant improvement over placebo in scores on the Cohen-Mansfield Agitation Inventory and the Neuropsychiatric Inventory (NPI), notably in the caregiver distress ratings on the NPI. There were no significant differences between the two study groups in scores on the Alzheimer Disease Cooperative Study-Activities of Daily Living scale or in the use of rescue lorazepam.

"Adverse events were generally modest and consistent with known SSRI-mediated adverse events (increases in gastrointestinal complaints, respiratory tract infections, and falls), except that no weight loss or hyponatremia was seen," the authors wrote, and the rate of serious adverse events was comparable between the two study groups. However, results on the Mini-Mental State Exam (MMSE) showed greater cognitive worsening with citalopram, and patients in that group also had more frequent falls and upper respiratory tract infections than did those in the placebo group.

There was no difference between the two study groups on measures of somnolence or confusion. The degree of cognitive worsening was small, and its clinical significance is uncertain. "Also unknown are whether this cognitive effect continues beyond 9 weeks and whether citalopram adversely affects the course of AD," Dr. Porsteinsson and his associates wrote.

The results of ECG monitoring initiated partway through CitAD were available for 24 patients in the citalopram group and 24 in the placebo group. They showed a greater increase in QTc interval and more patients with a high increase in QTc interval with the active drug (12.5%) than with placebo (4.3%), which is in line with the FDA advisory and current prescribing information.

At present, a maximum daily dose of 20 mg of citalopram is recommended for patients older than 60 years. "This trial did not have enough patients treated with the dose 20 mg per day to assess efficacy at that level," the investigators wrote.

The CitAD trial was supported by the National Institute on Aging, the National Institute of Mental Health, and the National Institutes of Health. Dr. Porsteinsson and his associates also reported numerous ties to industry sources.

Daily oral citalopram improved agitation in patients with Alzheimer’s disease and reduced caregiver stress but was associated with a higher rate of cardiac adverse effects than was placebo at the dose used in a multicenter, double-blind, randomized trial.

This benefit was of "clinically meaningful" magnitude and comparable to that reported for treatment with antipsychotic drugs. In addition, 40% of the study participants who received citalopram were deemed to be much or very much improved on a measure of clinically significant change in agitation, compared with 26% of those who received placebo, Dr. Anton P. Porsteinsson of the department of psychiatry at the University of Rochester (N.Y.) and his associates reported Feb. 18 in JAMA.

Cognitive decline, however, was slightly greater with citalopram than with placebo, and the active treatment was associated with QT-interval prolongation. These adverse effects are concerning, so citalopram, at least at the 30-mg daily dose used in this trial, "cannot be generally recommended as an alternative treatment option," the investigators said.

Citalopram, a selective serotonin reuptake inhibitor (SSRI), has been proposed as a safer alternative to antipsychotic drugs for agitation and aggression in dementia patients, even though until now there has only been limited evidence supporting its safety and efficacy. Dr. Porsteinsson and his colleagues conducted the Citalopram for Agitation in Alzheimer Disease (CitAD) study at eight U.S. and Canadian academic medical centers to further test the drug’s safety and efficacy in 186 AD patients who had significant agitation but no depression.

The average age of these study participants was 78 years; 46% were women, 65% were white and non-Hispanic, and 89% were community dwelling. All had dementia of at least 5 years’ duration. Approximately two-thirds took cholinesterase inhibitors and 42% took memantine (Namenda). All were allowed to receive lorazepam or trazodone as rescue medications for significant agitation or sleep disturbance.

A total of 94 patients were randomly assigned to receive 30 mg oral citalopram daily and 92 to receive a matching placebo in a double-blind fashion for 9 weeks. All the participants and their caregivers also received psychosocial support in the form of educational materials; 24-hour crisis management; a supportive-care plan; and 20- to 30-minute counseling sessions during study visits for individualized emotional support, skill building, and problem solving (JAMA 2014;311:682-91).

The trial took place between 2009 and 2013. Midway through in 2011, the U.S. Food and Drug Administration published an advisory that warned of a dose-dependent risk of QT prolongation with citalopram. The CitAD protocol was then amended to exclude participants with high QTc, to include ECG exams for all future participants, and to add serum magnesium to routine electrolyte monitoring.

The primary outcome measures were scores on the agitation subscale of the Neurobehavioral Rating Scale (NBRS-A) – which assesses agitation, hostility/uncooperativeness, and disinhibition – and scores on a modified version of the Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale. Participants receiving citalopram showed significant improvement on the NBRS-A, compared with those receiving placebo. Overall, 40% of the citalopram group, compared with only 26% of the placebo group, showed moderate to marked improvement on ADCS-CGIC scores.

Citalopram also offered significant improvement over placebo in scores on the Cohen-Mansfield Agitation Inventory and the Neuropsychiatric Inventory (NPI), notably in the caregiver distress ratings on the NPI. There were no significant differences between the two study groups in scores on the Alzheimer Disease Cooperative Study-Activities of Daily Living scale or in the use of rescue lorazepam.

"Adverse events were generally modest and consistent with known SSRI-mediated adverse events (increases in gastrointestinal complaints, respiratory tract infections, and falls), except that no weight loss or hyponatremia was seen," the authors wrote, and the rate of serious adverse events was comparable between the two study groups. However, results on the Mini-Mental State Exam (MMSE) showed greater cognitive worsening with citalopram, and patients in that group also had more frequent falls and upper respiratory tract infections than did those in the placebo group.

There was no difference between the two study groups on measures of somnolence or confusion. The degree of cognitive worsening was small, and its clinical significance is uncertain. "Also unknown are whether this cognitive effect continues beyond 9 weeks and whether citalopram adversely affects the course of AD," Dr. Porsteinsson and his associates wrote.

The results of ECG monitoring initiated partway through CitAD were available for 24 patients in the citalopram group and 24 in the placebo group. They showed a greater increase in QTc interval and more patients with a high increase in QTc interval with the active drug (12.5%) than with placebo (4.3%), which is in line with the FDA advisory and current prescribing information.

At present, a maximum daily dose of 20 mg of citalopram is recommended for patients older than 60 years. "This trial did not have enough patients treated with the dose 20 mg per day to assess efficacy at that level," the investigators wrote.

The CitAD trial was supported by the National Institute on Aging, the National Institute of Mental Health, and the National Institutes of Health. Dr. Porsteinsson and his associates also reported numerous ties to industry sources.

Daily oral citalopram improved agitation in patients with Alzheimer’s disease and reduced caregiver stress but was associated with a higher rate of cardiac adverse effects than was placebo at the dose used in a multicenter, double-blind, randomized trial.

This benefit was of "clinically meaningful" magnitude and comparable to that reported for treatment with antipsychotic drugs. In addition, 40% of the study participants who received citalopram were deemed to be much or very much improved on a measure of clinically significant change in agitation, compared with 26% of those who received placebo, Dr. Anton P. Porsteinsson of the department of psychiatry at the University of Rochester (N.Y.) and his associates reported Feb. 18 in JAMA.

Cognitive decline, however, was slightly greater with citalopram than with placebo, and the active treatment was associated with QT-interval prolongation. These adverse effects are concerning, so citalopram, at least at the 30-mg daily dose used in this trial, "cannot be generally recommended as an alternative treatment option," the investigators said.

Citalopram, a selective serotonin reuptake inhibitor (SSRI), has been proposed as a safer alternative to antipsychotic drugs for agitation and aggression in dementia patients, even though until now there has only been limited evidence supporting its safety and efficacy. Dr. Porsteinsson and his colleagues conducted the Citalopram for Agitation in Alzheimer Disease (CitAD) study at eight U.S. and Canadian academic medical centers to further test the drug’s safety and efficacy in 186 AD patients who had significant agitation but no depression.

The average age of these study participants was 78 years; 46% were women, 65% were white and non-Hispanic, and 89% were community dwelling. All had dementia of at least 5 years’ duration. Approximately two-thirds took cholinesterase inhibitors and 42% took memantine (Namenda). All were allowed to receive lorazepam or trazodone as rescue medications for significant agitation or sleep disturbance.

A total of 94 patients were randomly assigned to receive 30 mg oral citalopram daily and 92 to receive a matching placebo in a double-blind fashion for 9 weeks. All the participants and their caregivers also received psychosocial support in the form of educational materials; 24-hour crisis management; a supportive-care plan; and 20- to 30-minute counseling sessions during study visits for individualized emotional support, skill building, and problem solving (JAMA 2014;311:682-91).

The trial took place between 2009 and 2013. Midway through in 2011, the U.S. Food and Drug Administration published an advisory that warned of a dose-dependent risk of QT prolongation with citalopram. The CitAD protocol was then amended to exclude participants with high QTc, to include ECG exams for all future participants, and to add serum magnesium to routine electrolyte monitoring.

The primary outcome measures were scores on the agitation subscale of the Neurobehavioral Rating Scale (NBRS-A) – which assesses agitation, hostility/uncooperativeness, and disinhibition – and scores on a modified version of the Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale. Participants receiving citalopram showed significant improvement on the NBRS-A, compared with those receiving placebo. Overall, 40% of the citalopram group, compared with only 26% of the placebo group, showed moderate to marked improvement on ADCS-CGIC scores.

Citalopram also offered significant improvement over placebo in scores on the Cohen-Mansfield Agitation Inventory and the Neuropsychiatric Inventory (NPI), notably in the caregiver distress ratings on the NPI. There were no significant differences between the two study groups in scores on the Alzheimer Disease Cooperative Study-Activities of Daily Living scale or in the use of rescue lorazepam.

"Adverse events were generally modest and consistent with known SSRI-mediated adverse events (increases in gastrointestinal complaints, respiratory tract infections, and falls), except that no weight loss or hyponatremia was seen," the authors wrote, and the rate of serious adverse events was comparable between the two study groups. However, results on the Mini-Mental State Exam (MMSE) showed greater cognitive worsening with citalopram, and patients in that group also had more frequent falls and upper respiratory tract infections than did those in the placebo group.

There was no difference between the two study groups on measures of somnolence or confusion. The degree of cognitive worsening was small, and its clinical significance is uncertain. "Also unknown are whether this cognitive effect continues beyond 9 weeks and whether citalopram adversely affects the course of AD," Dr. Porsteinsson and his associates wrote.

The results of ECG monitoring initiated partway through CitAD were available for 24 patients in the citalopram group and 24 in the placebo group. They showed a greater increase in QTc interval and more patients with a high increase in QTc interval with the active drug (12.5%) than with placebo (4.3%), which is in line with the FDA advisory and current prescribing information.

At present, a maximum daily dose of 20 mg of citalopram is recommended for patients older than 60 years. "This trial did not have enough patients treated with the dose 20 mg per day to assess efficacy at that level," the investigators wrote.

The CitAD trial was supported by the National Institute on Aging, the National Institute of Mental Health, and the National Institutes of Health. Dr. Porsteinsson and his associates also reported numerous ties to industry sources.