Mary Ann Moon

The American Heart Association will broaden its focus to promoting cardiovascular health, in addition to its long-standing aim of reducing heart disease and stroke mortality, according to a special report.

The organization has adopted a new goal for the coming decade: “By 2020, to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20%,” said Dr. Donald M. Lloyd-Jones and his associates on the AHA strategic planning task force and statistics committee.

The special report “details the commission, underlying rationale, processes, and recommendations of the committee, which outline bold new strategic directions for the AHA.”

The report recommends that the AHA take on a more proactive role, emphasizing health promotion, cardiovascular disease (CVD) prevention, and improvement of quality of life, “rather than solely treating disease,” said Dr. Lloyd-Jones, chair of preventive medicine at Northwestern University, Chicago, and his colleagues.

The report also recommends that the AHA address the prevention of stroke and all CVD, not just coronary disease, and focus for the first time on congenital heart disease, nonfatal cardiovascular events, and health disparities (Circulation 2010 Jan. 20 [doi:10.1161/circulationaha.192703

As a first step in this effort, the committee established definitions of poor, intermediate, and ideal cardiovascular health.

The report also described goals in seven domains that are key to optimal cardiovascular health—“Life's Simple 7”—noting that if Americans improve these factors, their quality of life will improve, their life spans will increase, and the financial burden on the U.S. health care system will be dramatically reduced.

Specifically, Life's Simple 7 are:

▸ Never smoked or quit smoking more than 1 year ago.

▸ Body mass index less than 25 kg/m

▸ Physical activity at least 150 minutes (moderate intensity) or 75 minutes (vigorous intensity) per week.

▸ Healthy diet.

▸ Total cholesterol less than 200 mg/dL.

▸ Blood pressure less than 120/80 mm Hg.

▸ Fasting blood glucose less than 100 mg/dL.

“If we reach people in middle age and even younger with this message, we could change American health for the better for decades to come,” Dr. Lloyd-Jones commented in a statement issued by the AHA.

The AHA developed its 2020 goals and Life's Simple 7 after extensively reviewing the literature on cardiovascular health.

It became clear that more work needs to be done “to arrest or reverse a rising tide of CVD events due to the aging of the population and ongoing adverse levels of unhealthy behaviors (dietary imbalance, physical inactivity, smoking) and unhealthy risk factors (adverse blood lipids, high blood pressure, diabetes, obesity),” the report said.

The full report, including specific dietary and physical activity goals to promote cardiovascular health, is available at http://circ.ahajournals.org/cgi/content/full/121/4/586www.heart.org/MyLifeCheck

Disclosures: Dr. Lloyd-Jones had no financial conflicts to disclose. The potential conflicts of all the committee members are included in the report.

The American Heart Association will broaden its focus to promoting cardiovascular health, in addition to its long-standing aim of reducing heart disease and stroke mortality, according to a special report.

The organization has adopted a new goal for the coming decade: “By 2020, to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20%,” said Dr. Donald M. Lloyd-Jones and his associates on the AHA strategic planning task force and statistics committee.

The special report “details the commission, underlying rationale, processes, and recommendations of the committee, which outline bold new strategic directions for the AHA.”

The report recommends that the AHA take on a more proactive role, emphasizing health promotion, cardiovascular disease (CVD) prevention, and improvement of quality of life, “rather than solely treating disease,” said Dr. Lloyd-Jones, chair of preventive medicine at Northwestern University, Chicago, and his colleagues.

The report also recommends that the AHA address the prevention of stroke and all CVD, not just coronary disease, and focus for the first time on congenital heart disease, nonfatal cardiovascular events, and health disparities (Circulation 2010 Jan. 20 [doi:10.1161/circulationaha.192703

As a first step in this effort, the committee established definitions of poor, intermediate, and ideal cardiovascular health.

The report also described goals in seven domains that are key to optimal cardiovascular health—“Life's Simple 7”—noting that if Americans improve these factors, their quality of life will improve, their life spans will increase, and the financial burden on the U.S. health care system will be dramatically reduced.

Specifically, Life's Simple 7 are:

▸ Never smoked or quit smoking more than 1 year ago.

▸ Body mass index less than 25 kg/m

▸ Physical activity at least 150 minutes (moderate intensity) or 75 minutes (vigorous intensity) per week.

▸ Healthy diet.

▸ Total cholesterol less than 200 mg/dL.

▸ Blood pressure less than 120/80 mm Hg.

▸ Fasting blood glucose less than 100 mg/dL.

“If we reach people in middle age and even younger with this message, we could change American health for the better for decades to come,” Dr. Lloyd-Jones commented in a statement issued by the AHA.

The AHA developed its 2020 goals and Life's Simple 7 after extensively reviewing the literature on cardiovascular health.

It became clear that more work needs to be done “to arrest or reverse a rising tide of CVD events due to the aging of the population and ongoing adverse levels of unhealthy behaviors (dietary imbalance, physical inactivity, smoking) and unhealthy risk factors (adverse blood lipids, high blood pressure, diabetes, obesity),” the report said.

The full report, including specific dietary and physical activity goals to promote cardiovascular health, is available at http://circ.ahajournals.org/cgi/content/full/121/4/586www.heart.org/MyLifeCheck

Disclosures: Dr. Lloyd-Jones had no financial conflicts to disclose. The potential conflicts of all the committee members are included in the report.

The American Heart Association will broaden its focus to promoting cardiovascular health, in addition to its long-standing aim of reducing heart disease and stroke mortality, according to a special report.

The organization has adopted a new goal for the coming decade: “By 2020, to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20%,” said Dr. Donald M. Lloyd-Jones and his associates on the AHA strategic planning task force and statistics committee.

The special report “details the commission, underlying rationale, processes, and recommendations of the committee, which outline bold new strategic directions for the AHA.”

The report recommends that the AHA take on a more proactive role, emphasizing health promotion, cardiovascular disease (CVD) prevention, and improvement of quality of life, “rather than solely treating disease,” said Dr. Lloyd-Jones, chair of preventive medicine at Northwestern University, Chicago, and his colleagues.

The report also recommends that the AHA address the prevention of stroke and all CVD, not just coronary disease, and focus for the first time on congenital heart disease, nonfatal cardiovascular events, and health disparities (Circulation 2010 Jan. 20 [doi:10.1161/circulationaha.192703

As a first step in this effort, the committee established definitions of poor, intermediate, and ideal cardiovascular health.

The report also described goals in seven domains that are key to optimal cardiovascular health—“Life's Simple 7”—noting that if Americans improve these factors, their quality of life will improve, their life spans will increase, and the financial burden on the U.S. health care system will be dramatically reduced.

Specifically, Life's Simple 7 are:

▸ Never smoked or quit smoking more than 1 year ago.

▸ Body mass index less than 25 kg/m

▸ Physical activity at least 150 minutes (moderate intensity) or 75 minutes (vigorous intensity) per week.

▸ Healthy diet.

▸ Total cholesterol less than 200 mg/dL.

▸ Blood pressure less than 120/80 mm Hg.

▸ Fasting blood glucose less than 100 mg/dL.

“If we reach people in middle age and even younger with this message, we could change American health for the better for decades to come,” Dr. Lloyd-Jones commented in a statement issued by the AHA.

The AHA developed its 2020 goals and Life's Simple 7 after extensively reviewing the literature on cardiovascular health.

It became clear that more work needs to be done “to arrest or reverse a rising tide of CVD events due to the aging of the population and ongoing adverse levels of unhealthy behaviors (dietary imbalance, physical inactivity, smoking) and unhealthy risk factors (adverse blood lipids, high blood pressure, diabetes, obesity),” the report said.

The full report, including specific dietary and physical activity goals to promote cardiovascular health, is available at http://circ.ahajournals.org/cgi/content/full/121/4/586www.heart.org/MyLifeCheck

Disclosures: Dr. Lloyd-Jones had no financial conflicts to disclose. The potential conflicts of all the committee members are included in the report.

Elevated fasting plasma glucose levels during childhood—even within the normoglycemic range—appear to predict prediabetes and diabetes in young adulthood, according to a report from the Bogalusa Heart Study.

Moreover, high-normal fasting plasma glucose predicts later diabetes status independently of other traditional risk factors, said Dr. Quoc Manh Nguyen and associates at Tulane University, New Orleans.

Subjects were aged 4-18 years at study inception in 1978 and have been followed for a mean of 21 years. At the last survey, 1,723 subjects were classified as normoglycemic, 79 as prediabetic, and 47 as diabetic.

Subjects who had high-normal levels of fasting plasma glucose at baseline (86-99 mg/dL) were more than twice as likely to develop prediabetes or diabetes in young adulthood as were those with lower baseline levels.

Fasting plasma glucose level predicted later diabetes risk even after the data were controlled for other cardiometabolic risk factors, Dr. Nguyen and colleagues said (Arch. Ped. Adolesc. Med. 2010;164:124-8).

In an editorial, Dr. Matthew W. Gillman of Harvard Medical School, Boston, noted that the prevalence of prediabetes was 6%-7% among adults whose childhood glucose exceeded 86 mg/dL, but was only 2% for those whose childhood levels were lower.

Nevertheless, it would be premature to recommend using high-normal childhood glucose levels to predict later prediabetes. It would not be “sensible” to label all such children as at risk when only 7% are likely to develop the disorder, Dr. Gillman noted (Arch. Ped. Adolesc. Med. 2010;164:198-9).

The study was supported by the National Institute on Aging and the American Heart Association. Dr. Nguyen and Dr. Gillman reported no relevant conflicts of interest.

Elevated fasting plasma glucose levels during childhood—even within the normoglycemic range—appear to predict prediabetes and diabetes in young adulthood, according to a report from the Bogalusa Heart Study.

Moreover, high-normal fasting plasma glucose predicts later diabetes status independently of other traditional risk factors, said Dr. Quoc Manh Nguyen and associates at Tulane University, New Orleans.

Subjects were aged 4-18 years at study inception in 1978 and have been followed for a mean of 21 years. At the last survey, 1,723 subjects were classified as normoglycemic, 79 as prediabetic, and 47 as diabetic.

Subjects who had high-normal levels of fasting plasma glucose at baseline (86-99 mg/dL) were more than twice as likely to develop prediabetes or diabetes in young adulthood as were those with lower baseline levels.

Fasting plasma glucose level predicted later diabetes risk even after the data were controlled for other cardiometabolic risk factors, Dr. Nguyen and colleagues said (Arch. Ped. Adolesc. Med. 2010;164:124-8).

In an editorial, Dr. Matthew W. Gillman of Harvard Medical School, Boston, noted that the prevalence of prediabetes was 6%-7% among adults whose childhood glucose exceeded 86 mg/dL, but was only 2% for those whose childhood levels were lower.

Nevertheless, it would be premature to recommend using high-normal childhood glucose levels to predict later prediabetes. It would not be “sensible” to label all such children as at risk when only 7% are likely to develop the disorder, Dr. Gillman noted (Arch. Ped. Adolesc. Med. 2010;164:198-9).

The study was supported by the National Institute on Aging and the American Heart Association. Dr. Nguyen and Dr. Gillman reported no relevant conflicts of interest.

Elevated fasting plasma glucose levels during childhood—even within the normoglycemic range—appear to predict prediabetes and diabetes in young adulthood, according to a report from the Bogalusa Heart Study.

Moreover, high-normal fasting plasma glucose predicts later diabetes status independently of other traditional risk factors, said Dr. Quoc Manh Nguyen and associates at Tulane University, New Orleans.

Subjects were aged 4-18 years at study inception in 1978 and have been followed for a mean of 21 years. At the last survey, 1,723 subjects were classified as normoglycemic, 79 as prediabetic, and 47 as diabetic.

Subjects who had high-normal levels of fasting plasma glucose at baseline (86-99 mg/dL) were more than twice as likely to develop prediabetes or diabetes in young adulthood as were those with lower baseline levels.

Fasting plasma glucose level predicted later diabetes risk even after the data were controlled for other cardiometabolic risk factors, Dr. Nguyen and colleagues said (Arch. Ped. Adolesc. Med. 2010;164:124-8).

In an editorial, Dr. Matthew W. Gillman of Harvard Medical School, Boston, noted that the prevalence of prediabetes was 6%-7% among adults whose childhood glucose exceeded 86 mg/dL, but was only 2% for those whose childhood levels were lower.

Nevertheless, it would be premature to recommend using high-normal childhood glucose levels to predict later prediabetes. It would not be “sensible” to label all such children as at risk when only 7% are likely to develop the disorder, Dr. Gillman noted (Arch. Ped. Adolesc. Med. 2010;164:198-9).

The study was supported by the National Institute on Aging and the American Heart Association. Dr. Nguyen and Dr. Gillman reported no relevant conflicts of interest.

Funding of U.S. biomedical research, which enjoyed a “boom” in 1994-2003, has since declined substantially, according to investigators who tracked funding from four major sponsors of such research.

The current compounded annualized growth rate is 3.4%, compared with nearly 8% in the late 1990s and early 2000s, said Dr. E. Ray Dorsey of the University of Rochester (N.Y.) Medical Center and his associates.

The investigators had published a study in 2005 showing that public and private inflation-adjusted spending for biomedical research in the United States, had doubled over 1994-2003 (JAMA 2010;303:137–43).

They have extended that study to include data through 2008. They tracked funding from four major sponsors of biomedical research: the federal government; state and local governments; private, nonprofit groups such as foundations, charities, medical research organizations, and voluntary health organizations; and industry, including pharmaceutical, biotechnology, and medical device firms

Total funding for biomedical research increased from $75.5 billion in 2003 to $101.1 billion in 2007. Adjusted for inflation, this represents an increase of 14%. By comparison, the U.S. gross domestic product increased by 12% during the same time.

However, funding increased at a compound annual growth rate of only 3.4% in 2003-2007, compared with a nearly 8% rate in 1994-2003.

Industry spending on biomedical research also has decreased, from a compound annual growth rate of 8.1% in 1994-2003 to 5.8% in 2003-2007.

Federal funding increased by 0.7% in the more recent time period, compared with a nearly 100% increase during the previous time period. National Institutes of Health funding decreased nearly 9% in 2003-2007.

State and local government spending on biomedical research rose just 6% in recent years, compared with a 45% increase in 1994-2003. Funding by foundations and charities also slowed, especially during the recent recession, the investigators said.

Data on 2008 funding were available for only NIH and industry. Data adjusted for inflation show that funding from these two sources decreased from $90.2 billion in 2007 to $88.8 billion in 2008.

The study was supported by grants from the NIH. Dr. Dorsey and another colleague reported receiving research support from industry, NIH, and foundations. Dr. Dorsey also received research support from the American Academy of Neurology.

Funding of U.S. biomedical research, which enjoyed a “boom” in 1994-2003, has since declined substantially, according to investigators who tracked funding from four major sponsors of such research.

The current compounded annualized growth rate is 3.4%, compared with nearly 8% in the late 1990s and early 2000s, said Dr. E. Ray Dorsey of the University of Rochester (N.Y.) Medical Center and his associates.

The investigators had published a study in 2005 showing that public and private inflation-adjusted spending for biomedical research in the United States, had doubled over 1994-2003 (JAMA 2010;303:137–43).

They have extended that study to include data through 2008. They tracked funding from four major sponsors of biomedical research: the federal government; state and local governments; private, nonprofit groups such as foundations, charities, medical research organizations, and voluntary health organizations; and industry, including pharmaceutical, biotechnology, and medical device firms

Total funding for biomedical research increased from $75.5 billion in 2003 to $101.1 billion in 2007. Adjusted for inflation, this represents an increase of 14%. By comparison, the U.S. gross domestic product increased by 12% during the same time.

However, funding increased at a compound annual growth rate of only 3.4% in 2003-2007, compared with a nearly 8% rate in 1994-2003.

Industry spending on biomedical research also has decreased, from a compound annual growth rate of 8.1% in 1994-2003 to 5.8% in 2003-2007.

Federal funding increased by 0.7% in the more recent time period, compared with a nearly 100% increase during the previous time period. National Institutes of Health funding decreased nearly 9% in 2003-2007.

State and local government spending on biomedical research rose just 6% in recent years, compared with a 45% increase in 1994-2003. Funding by foundations and charities also slowed, especially during the recent recession, the investigators said.

Data on 2008 funding were available for only NIH and industry. Data adjusted for inflation show that funding from these two sources decreased from $90.2 billion in 2007 to $88.8 billion in 2008.

The study was supported by grants from the NIH. Dr. Dorsey and another colleague reported receiving research support from industry, NIH, and foundations. Dr. Dorsey also received research support from the American Academy of Neurology.

Funding of U.S. biomedical research, which enjoyed a “boom” in 1994-2003, has since declined substantially, according to investigators who tracked funding from four major sponsors of such research.

The current compounded annualized growth rate is 3.4%, compared with nearly 8% in the late 1990s and early 2000s, said Dr. E. Ray Dorsey of the University of Rochester (N.Y.) Medical Center and his associates.

The investigators had published a study in 2005 showing that public and private inflation-adjusted spending for biomedical research in the United States, had doubled over 1994-2003 (JAMA 2010;303:137–43).

They have extended that study to include data through 2008. They tracked funding from four major sponsors of biomedical research: the federal government; state and local governments; private, nonprofit groups such as foundations, charities, medical research organizations, and voluntary health organizations; and industry, including pharmaceutical, biotechnology, and medical device firms

Total funding for biomedical research increased from $75.5 billion in 2003 to $101.1 billion in 2007. Adjusted for inflation, this represents an increase of 14%. By comparison, the U.S. gross domestic product increased by 12% during the same time.

However, funding increased at a compound annual growth rate of only 3.4% in 2003-2007, compared with a nearly 8% rate in 1994-2003.

Industry spending on biomedical research also has decreased, from a compound annual growth rate of 8.1% in 1994-2003 to 5.8% in 2003-2007.

Federal funding increased by 0.7% in the more recent time period, compared with a nearly 100% increase during the previous time period. National Institutes of Health funding decreased nearly 9% in 2003-2007.

State and local government spending on biomedical research rose just 6% in recent years, compared with a 45% increase in 1994-2003. Funding by foundations and charities also slowed, especially during the recent recession, the investigators said.

Data on 2008 funding were available for only NIH and industry. Data adjusted for inflation show that funding from these two sources decreased from $90.2 billion in 2007 to $88.8 billion in 2008.

The study was supported by grants from the NIH. Dr. Dorsey and another colleague reported receiving research support from industry, NIH, and foundations. Dr. Dorsey also received research support from the American Academy of Neurology.

Intensive medical therapy for asymptomatic carotid stenosis has decreased the risk of stroke to such a degree that it has marginalized the benefits of revascularization in most patients, according to a retrospective study.

Intensive medical therapy, widely adopted after 2003, has cut the rate of microemboli to less than 4% and markedly reduced cardiovascular events, particularly stroke, in patients with asymptomatic carotid stenosis. It therefore should be considered the treatment of choice, said Dr. J. David Spence of the Stroke Prevention and Atherosclerosis Research Centre, London, Ont., and his associates.

Using data from a clinical trial documenting microemboli on transcranial Doppler imaging, they assessed 468 patients (mean age 70 years) with asymptomatic carotid stenosis. Subjects who were assessed during 2000–2002 (199 patients) were taking the less intensive medical therapy recommended at that time, whereas 269 patients assessed from January 2003 through July 2007 were taking the more aggressive medical therapy that is prevalent now.

The rate of microemboli was 13% before 2003, significantly higher than the 4% rate after 2003. Concomitantly, plasma lipid profiles steadily improved and the rate of carotid artery plaque progression markedly declined. More importantly, the rate of cardiovascular events dropped from 18% before 2003 to 5% afterward (Arch. Neurol. 20010;67[doi:10.1001/archneurol.2009.289]).

The study was funded by the Heart and Stroke Foundation of Ontario and the Stroke Prevention and Atherosclerosis Research Centre.

Intensive medical therapy for asymptomatic carotid stenosis has decreased the risk of stroke to such a degree that it has marginalized the benefits of revascularization in most patients, according to a retrospective study.

Intensive medical therapy, widely adopted after 2003, has cut the rate of microemboli to less than 4% and markedly reduced cardiovascular events, particularly stroke, in patients with asymptomatic carotid stenosis. It therefore should be considered the treatment of choice, said Dr. J. David Spence of the Stroke Prevention and Atherosclerosis Research Centre, London, Ont., and his associates.

Using data from a clinical trial documenting microemboli on transcranial Doppler imaging, they assessed 468 patients (mean age 70 years) with asymptomatic carotid stenosis. Subjects who were assessed during 2000–2002 (199 patients) were taking the less intensive medical therapy recommended at that time, whereas 269 patients assessed from January 2003 through July 2007 were taking the more aggressive medical therapy that is prevalent now.

The rate of microemboli was 13% before 2003, significantly higher than the 4% rate after 2003. Concomitantly, plasma lipid profiles steadily improved and the rate of carotid artery plaque progression markedly declined. More importantly, the rate of cardiovascular events dropped from 18% before 2003 to 5% afterward (Arch. Neurol. 20010;67[doi:10.1001/archneurol.2009.289]).

The study was funded by the Heart and Stroke Foundation of Ontario and the Stroke Prevention and Atherosclerosis Research Centre.

Intensive medical therapy for asymptomatic carotid stenosis has decreased the risk of stroke to such a degree that it has marginalized the benefits of revascularization in most patients, according to a retrospective study.

Intensive medical therapy, widely adopted after 2003, has cut the rate of microemboli to less than 4% and markedly reduced cardiovascular events, particularly stroke, in patients with asymptomatic carotid stenosis. It therefore should be considered the treatment of choice, said Dr. J. David Spence of the Stroke Prevention and Atherosclerosis Research Centre, London, Ont., and his associates.

Using data from a clinical trial documenting microemboli on transcranial Doppler imaging, they assessed 468 patients (mean age 70 years) with asymptomatic carotid stenosis. Subjects who were assessed during 2000–2002 (199 patients) were taking the less intensive medical therapy recommended at that time, whereas 269 patients assessed from January 2003 through July 2007 were taking the more aggressive medical therapy that is prevalent now.

The rate of microemboli was 13% before 2003, significantly higher than the 4% rate after 2003. Concomitantly, plasma lipid profiles steadily improved and the rate of carotid artery plaque progression markedly declined. More importantly, the rate of cardiovascular events dropped from 18% before 2003 to 5% afterward (Arch. Neurol. 20010;67[doi:10.1001/archneurol.2009.289]).

The study was funded by the Heart and Stroke Foundation of Ontario and the Stroke Prevention and Atherosclerosis Research Centre.

A variety of outcomes were poorer with off-pump than with on-pump coronary artery bypass graft in a prospective, randomized trial comparing the procedures.

Short-term and 1-year mortality, as well as rates of major complications, MI, revascularization procedures, and graft patency, were worse with the off-pump approach. Rates of neuropsychological sequelae were not significantly different.

“Our trial did not show any overall advantage to the use of the off-pump” coronary artery bypass graft (CABG), said A. Laurie Shroyer, Ph.D., of Northport (N.Y.) Veterans Affairs Medical Center, and associates in the Randomized On/Off Bypass (ROOBY) trial.

The study involved 2,203 patients undergoing elective or urgent CABG between 2002 and 2008 at 18 VA medical centers. Most (over 99%) were white men who were current or former smokers and had at least one comorbid condition; over 40% had diabetes. A majority had three-vessel coronary artery disease and normal left ventricular function, the authors wrote.

The patients were randomly assigned to on-pump (1,099 patients) or off-pump (1,104 patients) surgery while waiting in the preoperative holding area.

The primary short-term end point was a composite of death or major complications such as reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis within 30 days. The primary long-term end point was death from any cause, nonfatal MI, or repeat revascularization within 1 year.

The short-term composite outcome was not significantly different between the two groups, affecting 7.0% of the off-pump group and 5.6% of the on-pump group. In contrast, the long-term composite outcome was significantly higher in the off-pump group (9.9%) than in the on-pump group (7.4%).

A subsequent sensitivity analysis of the data “showed even stronger advantages for on-pump procedures,” the investigators said (N. Engl. J. Med. 2009;361:1827–37).

The rate of graft patency at 1 year was significantly lower for the off-pump group (82.6%) than the on-pump group (87.8%). Significantly more patients in the off-pump group (36.5%) had at least 1 occluded graft than in the on-pump group (28.7%).

Among those with no occluded grafts, the primary 1-year composite outcome was lower in the on-pump group than in the off-pump (3.3% vs. 6.4%), because “there was less complete revascularization in the off-pump group,” the researchers wrote.

A subset of 1,156 study subjects had completed a battery of neuropsychological tests at baseline and was retested at 1 year. Dysfunctions in attention, memory, and visuospatial skills were assessed.

Unexpectedly, there were no significant differences between the two treatment groups on these measures, and the changes in individual test scores either were minimal or showed improvement after surgery for both groups, Dr. Shroyer and colleagues said.

“A number of studies have suggested that cardiopulmonary bypass causes permanent neurologic dysfunction or decreases cognition and motor abilities. Our trial did not show a cognitive decline within 1 year after surgery in either group,” they noted.

In an editorial comment, Dr. Eric David Peterson of Duke University Medical Center, Durham, N.C., said the ROOBY study was rigorously conducted, included a broad range of longitudinal clinical end points, and had adequate statistical power to justify its conclusions.

Nevertheless, these findings are “unlikely to end the debate about on-pump and off-pump CABG.” Research has shown that the off-pump approach may be particularly suited to women, the elderly, and people with severe coexisting illnesses, “yet the ROOBY trial enrolled almost entirely men who were on average younger and healthier than typical candidates for CABG,” Dr. Peterson said (N. Engl. J. Med. 2009;361:1897–9).

Critics also may question whether the technical experience of the surgeons and anesthesiologists was adequately adjusted for in the analysis. In more than half of these cases, the primary surgeon was a surgical resident, he noted.

Dr. Shroyer and Dr. Peterson reported no potential conflicts of interest.

A variety of outcomes were poorer with off-pump than with on-pump coronary artery bypass graft in a prospective, randomized trial comparing the procedures.

Short-term and 1-year mortality, as well as rates of major complications, MI, revascularization procedures, and graft patency, were worse with the off-pump approach. Rates of neuropsychological sequelae were not significantly different.

“Our trial did not show any overall advantage to the use of the off-pump” coronary artery bypass graft (CABG), said A. Laurie Shroyer, Ph.D., of Northport (N.Y.) Veterans Affairs Medical Center, and associates in the Randomized On/Off Bypass (ROOBY) trial.

The study involved 2,203 patients undergoing elective or urgent CABG between 2002 and 2008 at 18 VA medical centers. Most (over 99%) were white men who were current or former smokers and had at least one comorbid condition; over 40% had diabetes. A majority had three-vessel coronary artery disease and normal left ventricular function, the authors wrote.

The patients were randomly assigned to on-pump (1,099 patients) or off-pump (1,104 patients) surgery while waiting in the preoperative holding area.

The primary short-term end point was a composite of death or major complications such as reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis within 30 days. The primary long-term end point was death from any cause, nonfatal MI, or repeat revascularization within 1 year.

The short-term composite outcome was not significantly different between the two groups, affecting 7.0% of the off-pump group and 5.6% of the on-pump group. In contrast, the long-term composite outcome was significantly higher in the off-pump group (9.9%) than in the on-pump group (7.4%).

A subsequent sensitivity analysis of the data “showed even stronger advantages for on-pump procedures,” the investigators said (N. Engl. J. Med. 2009;361:1827–37).

The rate of graft patency at 1 year was significantly lower for the off-pump group (82.6%) than the on-pump group (87.8%). Significantly more patients in the off-pump group (36.5%) had at least 1 occluded graft than in the on-pump group (28.7%).

Among those with no occluded grafts, the primary 1-year composite outcome was lower in the on-pump group than in the off-pump (3.3% vs. 6.4%), because “there was less complete revascularization in the off-pump group,” the researchers wrote.

A subset of 1,156 study subjects had completed a battery of neuropsychological tests at baseline and was retested at 1 year. Dysfunctions in attention, memory, and visuospatial skills were assessed.

Unexpectedly, there were no significant differences between the two treatment groups on these measures, and the changes in individual test scores either were minimal or showed improvement after surgery for both groups, Dr. Shroyer and colleagues said.

“A number of studies have suggested that cardiopulmonary bypass causes permanent neurologic dysfunction or decreases cognition and motor abilities. Our trial did not show a cognitive decline within 1 year after surgery in either group,” they noted.

In an editorial comment, Dr. Eric David Peterson of Duke University Medical Center, Durham, N.C., said the ROOBY study was rigorously conducted, included a broad range of longitudinal clinical end points, and had adequate statistical power to justify its conclusions.

Nevertheless, these findings are “unlikely to end the debate about on-pump and off-pump CABG.” Research has shown that the off-pump approach may be particularly suited to women, the elderly, and people with severe coexisting illnesses, “yet the ROOBY trial enrolled almost entirely men who were on average younger and healthier than typical candidates for CABG,” Dr. Peterson said (N. Engl. J. Med. 2009;361:1897–9).

Critics also may question whether the technical experience of the surgeons and anesthesiologists was adequately adjusted for in the analysis. In more than half of these cases, the primary surgeon was a surgical resident, he noted.

Dr. Shroyer and Dr. Peterson reported no potential conflicts of interest.

A variety of outcomes were poorer with off-pump than with on-pump coronary artery bypass graft in a prospective, randomized trial comparing the procedures.

Short-term and 1-year mortality, as well as rates of major complications, MI, revascularization procedures, and graft patency, were worse with the off-pump approach. Rates of neuropsychological sequelae were not significantly different.

“Our trial did not show any overall advantage to the use of the off-pump” coronary artery bypass graft (CABG), said A. Laurie Shroyer, Ph.D., of Northport (N.Y.) Veterans Affairs Medical Center, and associates in the Randomized On/Off Bypass (ROOBY) trial.

The study involved 2,203 patients undergoing elective or urgent CABG between 2002 and 2008 at 18 VA medical centers. Most (over 99%) were white men who were current or former smokers and had at least one comorbid condition; over 40% had diabetes. A majority had three-vessel coronary artery disease and normal left ventricular function, the authors wrote.

The patients were randomly assigned to on-pump (1,099 patients) or off-pump (1,104 patients) surgery while waiting in the preoperative holding area.

The primary short-term end point was a composite of death or major complications such as reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis within 30 days. The primary long-term end point was death from any cause, nonfatal MI, or repeat revascularization within 1 year.

The short-term composite outcome was not significantly different between the two groups, affecting 7.0% of the off-pump group and 5.6% of the on-pump group. In contrast, the long-term composite outcome was significantly higher in the off-pump group (9.9%) than in the on-pump group (7.4%).

A subsequent sensitivity analysis of the data “showed even stronger advantages for on-pump procedures,” the investigators said (N. Engl. J. Med. 2009;361:1827–37).

The rate of graft patency at 1 year was significantly lower for the off-pump group (82.6%) than the on-pump group (87.8%). Significantly more patients in the off-pump group (36.5%) had at least 1 occluded graft than in the on-pump group (28.7%).

Among those with no occluded grafts, the primary 1-year composite outcome was lower in the on-pump group than in the off-pump (3.3% vs. 6.4%), because “there was less complete revascularization in the off-pump group,” the researchers wrote.

A subset of 1,156 study subjects had completed a battery of neuropsychological tests at baseline and was retested at 1 year. Dysfunctions in attention, memory, and visuospatial skills were assessed.

Unexpectedly, there were no significant differences between the two treatment groups on these measures, and the changes in individual test scores either were minimal or showed improvement after surgery for both groups, Dr. Shroyer and colleagues said.

“A number of studies have suggested that cardiopulmonary bypass causes permanent neurologic dysfunction or decreases cognition and motor abilities. Our trial did not show a cognitive decline within 1 year after surgery in either group,” they noted.

In an editorial comment, Dr. Eric David Peterson of Duke University Medical Center, Durham, N.C., said the ROOBY study was rigorously conducted, included a broad range of longitudinal clinical end points, and had adequate statistical power to justify its conclusions.

Nevertheless, these findings are “unlikely to end the debate about on-pump and off-pump CABG.” Research has shown that the off-pump approach may be particularly suited to women, the elderly, and people with severe coexisting illnesses, “yet the ROOBY trial enrolled almost entirely men who were on average younger and healthier than typical candidates for CABG,” Dr. Peterson said (N. Engl. J. Med. 2009;361:1897–9).

Critics also may question whether the technical experience of the surgeons and anesthesiologists was adequately adjusted for in the analysis. In more than half of these cases, the primary surgeon was a surgical resident, he noted.

Dr. Shroyer and Dr. Peterson reported no potential conflicts of interest.

Most commonly used antibacterial drugs were not associated with birth defects in a large surveillance study.

The study was performed because even though some antibiotics have been used relatively safely during pregnancy for decades, until now “there have been no large-scale studies addressing safety or risk [of birth defects] for many classes of antibacterial drugs,” said Krista S. Crider, Ph.D., and her associates in the National Birth Defects Prevention Study.

Their findings lend “support to the established safety profiles for certain classes of antibacterial [drugs] such as penicillins, erythromycins, and cephalosporins.” In addition, the investigators found it “encouraging” that the use of antibacterial drugs suspected of being teratogenic—such as aminoglycosides, chloramphenicol, and tetracyclines—was “extremely low to none at all” among women just before conception and in early pregnancy (Arch. Ped. Adolesc. Med. 2009;163:978-85).

However, the use of other classes of antibacterial drugs, notably sulfonamides and nitrofurantoins, appeared to be associated with a higher risk for several birth defects, “indicating a need for additional scrutiny,” said Dr. Crider of the Centers for Disease Control and Prevention and her colleagues.

The researchers assessed prenatal exposure to antimicrobial drugs in 13,155 mothers of infants with birth defects (cases) born in 1997-2003 and 4,941 mothers of infants without major birth defects (controls) born in the same geographical locations during the same interval.

The case infants had at least 1 of more than 30 categories of major birth defects identified by surveillance systems in 10 states across the country. The cases included live births, stillbirths, and induced abortions.

This self-report was obtained through telephone interviews 6 weeks to 2 years following delivery. Such a lag time means that some women may not have fully or accurately recalled all their antibacterial drug exposures, or the exact timing of each exposure, the investigators noted. Exposure to antibacterial drugs was common among both case (29.4%) and control (29.7%) mothers.

Penicillins were the most frequently used agents. These antibacterial drugs were associated with an increased odds ratio for only one defect (intercalary limb deficiency). That association was not strong, because there were only 24 total cases of this defect.

Erythromycins were the next most frequently used antibacterial drugs. “Only anencephaly and transverse limb deficiency were associated with erythromycin exposure,” they noted. Similarly, cephalosporins showed only one significantly increased odds ratio, and that was for atrial septal defects.

Quinolones were used infrequently, as they are not recommended during pregnancy. They were associated with the conotruncal defect tetralogy of Fallot.

Nitrofurantoins were associated with anophthalmia or microphthalmos, hypoplastic left heart syndrome, atrial septal defects, and cleft lip with cleft palate.

Tetracyclines were associated with a variety of heart defects plus left ventricular outflow obstruction defects, septal heart defects, and oral clefts.

Exposure to sulfonamides was associated with the most defects, including anencephaly, hypoplastic left heart syndrome, coarctation of the aorta, choanal atresia, transverse limb deficiency, and diaphragmatic hernia. Moreover, associations between sulfonamides and tetralogy of Fallot, small intestinal atresia or stenosis, and craniosynostosis fell just short of statistical significance.

Disclosures: None was reported.

Most commonly used antibacterial drugs were not associated with birth defects in a large surveillance study.

The study was performed because even though some antibiotics have been used relatively safely during pregnancy for decades, until now “there have been no large-scale studies addressing safety or risk [of birth defects] for many classes of antibacterial drugs,” said Krista S. Crider, Ph.D., and her associates in the National Birth Defects Prevention Study.

Their findings lend “support to the established safety profiles for certain classes of antibacterial [drugs] such as penicillins, erythromycins, and cephalosporins.” In addition, the investigators found it “encouraging” that the use of antibacterial drugs suspected of being teratogenic—such as aminoglycosides, chloramphenicol, and tetracyclines—was “extremely low to none at all” among women just before conception and in early pregnancy (Arch. Ped. Adolesc. Med. 2009;163:978-85).

However, the use of other classes of antibacterial drugs, notably sulfonamides and nitrofurantoins, appeared to be associated with a higher risk for several birth defects, “indicating a need for additional scrutiny,” said Dr. Crider of the Centers for Disease Control and Prevention and her colleagues.

The researchers assessed prenatal exposure to antimicrobial drugs in 13,155 mothers of infants with birth defects (cases) born in 1997-2003 and 4,941 mothers of infants without major birth defects (controls) born in the same geographical locations during the same interval.

The case infants had at least 1 of more than 30 categories of major birth defects identified by surveillance systems in 10 states across the country. The cases included live births, stillbirths, and induced abortions.

This self-report was obtained through telephone interviews 6 weeks to 2 years following delivery. Such a lag time means that some women may not have fully or accurately recalled all their antibacterial drug exposures, or the exact timing of each exposure, the investigators noted. Exposure to antibacterial drugs was common among both case (29.4%) and control (29.7%) mothers.

Penicillins were the most frequently used agents. These antibacterial drugs were associated with an increased odds ratio for only one defect (intercalary limb deficiency). That association was not strong, because there were only 24 total cases of this defect.

Erythromycins were the next most frequently used antibacterial drugs. “Only anencephaly and transverse limb deficiency were associated with erythromycin exposure,” they noted. Similarly, cephalosporins showed only one significantly increased odds ratio, and that was for atrial septal defects.

Quinolones were used infrequently, as they are not recommended during pregnancy. They were associated with the conotruncal defect tetralogy of Fallot.

Nitrofurantoins were associated with anophthalmia or microphthalmos, hypoplastic left heart syndrome, atrial septal defects, and cleft lip with cleft palate.

Tetracyclines were associated with a variety of heart defects plus left ventricular outflow obstruction defects, septal heart defects, and oral clefts.

Exposure to sulfonamides was associated with the most defects, including anencephaly, hypoplastic left heart syndrome, coarctation of the aorta, choanal atresia, transverse limb deficiency, and diaphragmatic hernia. Moreover, associations between sulfonamides and tetralogy of Fallot, small intestinal atresia or stenosis, and craniosynostosis fell just short of statistical significance.

Disclosures: None was reported.

Most commonly used antibacterial drugs were not associated with birth defects in a large surveillance study.

The study was performed because even though some antibiotics have been used relatively safely during pregnancy for decades, until now “there have been no large-scale studies addressing safety or risk [of birth defects] for many classes of antibacterial drugs,” said Krista S. Crider, Ph.D., and her associates in the National Birth Defects Prevention Study.

Their findings lend “support to the established safety profiles for certain classes of antibacterial [drugs] such as penicillins, erythromycins, and cephalosporins.” In addition, the investigators found it “encouraging” that the use of antibacterial drugs suspected of being teratogenic—such as aminoglycosides, chloramphenicol, and tetracyclines—was “extremely low to none at all” among women just before conception and in early pregnancy (Arch. Ped. Adolesc. Med. 2009;163:978-85).

However, the use of other classes of antibacterial drugs, notably sulfonamides and nitrofurantoins, appeared to be associated with a higher risk for several birth defects, “indicating a need for additional scrutiny,” said Dr. Crider of the Centers for Disease Control and Prevention and her colleagues.

The researchers assessed prenatal exposure to antimicrobial drugs in 13,155 mothers of infants with birth defects (cases) born in 1997-2003 and 4,941 mothers of infants without major birth defects (controls) born in the same geographical locations during the same interval.

The case infants had at least 1 of more than 30 categories of major birth defects identified by surveillance systems in 10 states across the country. The cases included live births, stillbirths, and induced abortions.

This self-report was obtained through telephone interviews 6 weeks to 2 years following delivery. Such a lag time means that some women may not have fully or accurately recalled all their antibacterial drug exposures, or the exact timing of each exposure, the investigators noted. Exposure to antibacterial drugs was common among both case (29.4%) and control (29.7%) mothers.

Penicillins were the most frequently used agents. These antibacterial drugs were associated with an increased odds ratio for only one defect (intercalary limb deficiency). That association was not strong, because there were only 24 total cases of this defect.

Erythromycins were the next most frequently used antibacterial drugs. “Only anencephaly and transverse limb deficiency were associated with erythromycin exposure,” they noted. Similarly, cephalosporins showed only one significantly increased odds ratio, and that was for atrial septal defects.

Quinolones were used infrequently, as they are not recommended during pregnancy. They were associated with the conotruncal defect tetralogy of Fallot.

Nitrofurantoins were associated with anophthalmia or microphthalmos, hypoplastic left heart syndrome, atrial septal defects, and cleft lip with cleft palate.

Tetracyclines were associated with a variety of heart defects plus left ventricular outflow obstruction defects, septal heart defects, and oral clefts.

Exposure to sulfonamides was associated with the most defects, including anencephaly, hypoplastic left heart syndrome, coarctation of the aorta, choanal atresia, transverse limb deficiency, and diaphragmatic hernia. Moreover, associations between sulfonamides and tetralogy of Fallot, small intestinal atresia or stenosis, and craniosynostosis fell just short of statistical significance.

Disclosures: None was reported.

Funding of U.S. biomedical research, which enjoyed a “boom” between 1994 and 2003, has since slowed substantially.

It appears that the “boom and bust” cycling of research spending that has prevailed since the 1940s may now be entering a “bust” phase, with the current compounded annualized growth rate at 3.4%, compared with nearly 8% in the late 1990s and early 2000s, said Dr. E. Ray Dorsey of the University of Rochester (N.Y.) Medical Center and his associates (JAMA 2010;303:137–43).

The investigators published a study in 2005 that examined public and private financial support of biomedical research in the United States in 1994–2003. During that interval, the nominal amount of such spending tripled and the adjusted-for-inflation amount doubled.

The researchers have now extended that study to include data through 2008. They tracked funding from four major sponsors of research: the federal government, chiefly the National Institutes of Health, which provides 85% of federal funding; state and local governments; private, not-for-profit groups such as foundations, charities, and medical research organizations; and industry, including pharmaceutical, biotechnology, and medical device firms.

Total funding for biomedical research increased from $75.5 billion in 2003 to $101.1 billion in 2007. Adjusted for inflation, this represents an increase of 14%. By comparison, the U.S. gross domestic product increased by 12% during the same time. Funding, however, increased at a compound annual growth rate of only 3.4% in 2003–2007, compared with a nearly 8% rate in 1994–2003.

Industry spending on biomedical research also has slowed from a compound annual growth rate of 8.1% in 1994–2003 to 5.8% in 2003–2007.

Federal funding increased by 0.7% in the more recent time period, compared with a nearly 100% increase during the previous time period. In particular, NIH funding decreased nearly 9% between 2003 and 2007.

State and local government spending on biomedical research rose just 6% in recent years, compared with a 45% increase in 1994–2003. Funding by foundations and charities also slowed, especially during the recent recession, the investigators said.

Data on 2008 funding were available for only two of the four major sources: NIH and industry. In just that 1 year, data adjusted for inflation show that funding from these two important sources decreased markedly, from $90.2 billion in 2007 to $88.8 billion in 2008.

The declines since 2003 may signal “a trend to favor incremental research rather than high-risk/high-reward avenues,” they added.

Dr. Dorsey reported receiving research support from NIH, foundations, and industry. One other researcher reported relationships with advisory groups that work with foundations and industry.

Funding of U.S. biomedical research, which enjoyed a “boom” between 1994 and 2003, has since slowed substantially.

It appears that the “boom and bust” cycling of research spending that has prevailed since the 1940s may now be entering a “bust” phase, with the current compounded annualized growth rate at 3.4%, compared with nearly 8% in the late 1990s and early 2000s, said Dr. E. Ray Dorsey of the University of Rochester (N.Y.) Medical Center and his associates (JAMA 2010;303:137–43).

The investigators published a study in 2005 that examined public and private financial support of biomedical research in the United States in 1994–2003. During that interval, the nominal amount of such spending tripled and the adjusted-for-inflation amount doubled.

The researchers have now extended that study to include data through 2008. They tracked funding from four major sponsors of research: the federal government, chiefly the National Institutes of Health, which provides 85% of federal funding; state and local governments; private, not-for-profit groups such as foundations, charities, and medical research organizations; and industry, including pharmaceutical, biotechnology, and medical device firms.

Total funding for biomedical research increased from $75.5 billion in 2003 to $101.1 billion in 2007. Adjusted for inflation, this represents an increase of 14%. By comparison, the U.S. gross domestic product increased by 12% during the same time. Funding, however, increased at a compound annual growth rate of only 3.4% in 2003–2007, compared with a nearly 8% rate in 1994–2003.

Industry spending on biomedical research also has slowed from a compound annual growth rate of 8.1% in 1994–2003 to 5.8% in 2003–2007.

Federal funding increased by 0.7% in the more recent time period, compared with a nearly 100% increase during the previous time period. In particular, NIH funding decreased nearly 9% between 2003 and 2007.

State and local government spending on biomedical research rose just 6% in recent years, compared with a 45% increase in 1994–2003. Funding by foundations and charities also slowed, especially during the recent recession, the investigators said.

Data on 2008 funding were available for only two of the four major sources: NIH and industry. In just that 1 year, data adjusted for inflation show that funding from these two important sources decreased markedly, from $90.2 billion in 2007 to $88.8 billion in 2008.

The declines since 2003 may signal “a trend to favor incremental research rather than high-risk/high-reward avenues,” they added.

Dr. Dorsey reported receiving research support from NIH, foundations, and industry. One other researcher reported relationships with advisory groups that work with foundations and industry.

Funding of U.S. biomedical research, which enjoyed a “boom” between 1994 and 2003, has since slowed substantially.

It appears that the “boom and bust” cycling of research spending that has prevailed since the 1940s may now be entering a “bust” phase, with the current compounded annualized growth rate at 3.4%, compared with nearly 8% in the late 1990s and early 2000s, said Dr. E. Ray Dorsey of the University of Rochester (N.Y.) Medical Center and his associates (JAMA 2010;303:137–43).

The investigators published a study in 2005 that examined public and private financial support of biomedical research in the United States in 1994–2003. During that interval, the nominal amount of such spending tripled and the adjusted-for-inflation amount doubled.

The researchers have now extended that study to include data through 2008. They tracked funding from four major sponsors of research: the federal government, chiefly the National Institutes of Health, which provides 85% of federal funding; state and local governments; private, not-for-profit groups such as foundations, charities, and medical research organizations; and industry, including pharmaceutical, biotechnology, and medical device firms.

Total funding for biomedical research increased from $75.5 billion in 2003 to $101.1 billion in 2007. Adjusted for inflation, this represents an increase of 14%. By comparison, the U.S. gross domestic product increased by 12% during the same time. Funding, however, increased at a compound annual growth rate of only 3.4% in 2003–2007, compared with a nearly 8% rate in 1994–2003.

Industry spending on biomedical research also has slowed from a compound annual growth rate of 8.1% in 1994–2003 to 5.8% in 2003–2007.

Federal funding increased by 0.7% in the more recent time period, compared with a nearly 100% increase during the previous time period. In particular, NIH funding decreased nearly 9% between 2003 and 2007.

State and local government spending on biomedical research rose just 6% in recent years, compared with a 45% increase in 1994–2003. Funding by foundations and charities also slowed, especially during the recent recession, the investigators said.

Data on 2008 funding were available for only two of the four major sources: NIH and industry. In just that 1 year, data adjusted for inflation show that funding from these two important sources decreased markedly, from $90.2 billion in 2007 to $88.8 billion in 2008.

The declines since 2003 may signal “a trend to favor incremental research rather than high-risk/high-reward avenues,” they added.

Dr. Dorsey reported receiving research support from NIH, foundations, and industry. One other researcher reported relationships with advisory groups that work with foundations and industry.

Researchers have identified a genetic locus on chromosome 1q31 that is significantly associated with susceptibility to asthma.

Two candidate genes at this locus were identified in a genome-wide association study of North American children of European ancestry, and the findings were replicated in a cohort of European adults and a population of North American children of African ancestry, said Patrick M. A. Sleiman, Ph.D., of Children's Hospital at Philadelphia's Center for Applied Genomics and his associates (N. Engl. J. Med. 2009 [doi:10.1056/NEJMoa0901867

The researchers first performed a genome-wide association study in a cohort of 793 children (mean age 7 years) who had moderate to severe asthma requiring daily cortico-steroid therapy. A control group of 1,988 nonasthmatic children also was assessed. All the children were Americans of European ancestry.

Eight single-nucleotide polymorphisms (SNPs) were found to be significantly associated with asthma. All mapped to the DENND1B gene or the CRB1 gene at a novel locus on chromosome 1q31. The findings were replicated in a European cohort of 917 adults with childhood-onset asthma and 1,546 control subjects.

A cohort of 1,667 African American children with asthma and 2,045 African American children without asthma was then assessed. Again, each of the eight SNPs on chromosome 1q31 was strongly associated with asthma.

The study was supported by an award from the Children's Hospital of Philadelphia, and grants from the state of Pennsylvania, the Lundbeck Foundation, and the National Institutes of Health. No conflicts of interest were reported.

Researchers have identified a genetic locus on chromosome 1q31 that is significantly associated with susceptibility to asthma.

Two candidate genes at this locus were identified in a genome-wide association study of North American children of European ancestry, and the findings were replicated in a cohort of European adults and a population of North American children of African ancestry, said Patrick M. A. Sleiman, Ph.D., of Children's Hospital at Philadelphia's Center for Applied Genomics and his associates (N. Engl. J. Med. 2009 [doi:10.1056/NEJMoa0901867

The researchers first performed a genome-wide association study in a cohort of 793 children (mean age 7 years) who had moderate to severe asthma requiring daily cortico-steroid therapy. A control group of 1,988 nonasthmatic children also was assessed. All the children were Americans of European ancestry.

Eight single-nucleotide polymorphisms (SNPs) were found to be significantly associated with asthma. All mapped to the DENND1B gene or the CRB1 gene at a novel locus on chromosome 1q31. The findings were replicated in a European cohort of 917 adults with childhood-onset asthma and 1,546 control subjects.

A cohort of 1,667 African American children with asthma and 2,045 African American children without asthma was then assessed. Again, each of the eight SNPs on chromosome 1q31 was strongly associated with asthma.

The study was supported by an award from the Children's Hospital of Philadelphia, and grants from the state of Pennsylvania, the Lundbeck Foundation, and the National Institutes of Health. No conflicts of interest were reported.

Researchers have identified a genetic locus on chromosome 1q31 that is significantly associated with susceptibility to asthma.

Two candidate genes at this locus were identified in a genome-wide association study of North American children of European ancestry, and the findings were replicated in a cohort of European adults and a population of North American children of African ancestry, said Patrick M. A. Sleiman, Ph.D., of Children's Hospital at Philadelphia's Center for Applied Genomics and his associates (N. Engl. J. Med. 2009 [doi:10.1056/NEJMoa0901867

The researchers first performed a genome-wide association study in a cohort of 793 children (mean age 7 years) who had moderate to severe asthma requiring daily cortico-steroid therapy. A control group of 1,988 nonasthmatic children also was assessed. All the children were Americans of European ancestry.

Eight single-nucleotide polymorphisms (SNPs) were found to be significantly associated with asthma. All mapped to the DENND1B gene or the CRB1 gene at a novel locus on chromosome 1q31. The findings were replicated in a European cohort of 917 adults with childhood-onset asthma and 1,546 control subjects.

A cohort of 1,667 African American children with asthma and 2,045 African American children without asthma was then assessed. Again, each of the eight SNPs on chromosome 1q31 was strongly associated with asthma.

The study was supported by an award from the Children's Hospital of Philadelphia, and grants from the state of Pennsylvania, the Lundbeck Foundation, and the National Institutes of Health. No conflicts of interest were reported.

Major Finding: Patients with chronic midportion Achilles tendinopathy received no benefit from injections of platelet-rich plasma (PRP).

Data Source: In a blinded, randomized, placebo-controlled trial, 27 patients were treated with PRP injections and 27 were treated with placebo injections.

Disclosures: Funded by Biomet Biologics. No other disclosures were reported.

Injections of platelet-rich plasma failed to improve pain or function in the first blinded, randomized placebo-controlled trial of the new technique for Achilles tendinopathy, results from a small study suggest.

The treatment also delivered no more patient satisfaction than placebo injections, nor did it facilitate a return to sports activity.

“These findings are important and clinically relevant as PRP is thought to be growing in popularity, and recent reviews supported its use for chronic tendon disorders,” said Dr. Robert J. de Vos of Erasmus University Medical Center, Rotterdam, the Netherlands, and his associates (JAMA 2010;303:144–9).

Platelet-rich plasma injections “raised high expectations” when they were introduced because PRP contains several growth factors that are known to play a role in tissue repair.

It was thought that relatively high concentrations of vascular endothelial growth factor, platelet-derived growth factor, and transforming growth factor–beta could help regenerate tendon tissue “through increased tendon cell proliferation, collagen synthesis, and vascularization.”

In their trial, Dr. de Vos and his colleagues compared PRP injections with placebo injections in 54 patients who were treated at the sports medicine outpatient department of a single large hospital for chronic midportion Achilles tendinopathy.

The pain was located approximately 2–7 cm proximal to the tendon's insertion on the calcaneus.

The tendon structure was examined using ultrasound, and the fluid was injected through three puncture locations. Five small depots were left at each location, within the degenerative area of the main body of the tendon.

All subjects underwent a standard rehabilitation program that included daily stretching and eccentric exercises—primarily “heel drops” performed on a step, which stretched the Achilles tendon while concurrently contracting the calf muscle.

At 6, 12, and 24 weeks' follow-up, scores were no different between the 27 patients who received active injections and the 27 who received placebo injections, on a measure of pain and activity specifically addressing Achilles tendinopathy.

Subjective patient satisfaction also was not significantly different between the two groups, according to the results. The same was true for the number of subjects able to return to their desired sport after 24 weeks.

The use of PRP injections in clinical practice has been based on the findings of laboratory studies and a few small clinical studies that did not include a proper control group and were not blinded, Dr. de Vos and his associates noted.

Given the results of their clinical trial, “we do not recommend this treatment for chronic midportion Achilles tendinopathy,” they said.

Major Finding: Patients with chronic midportion Achilles tendinopathy received no benefit from injections of platelet-rich plasma (PRP).

Data Source: In a blinded, randomized, placebo-controlled trial, 27 patients were treated with PRP injections and 27 were treated with placebo injections.

Disclosures: Funded by Biomet Biologics. No other disclosures were reported.

Injections of platelet-rich plasma failed to improve pain or function in the first blinded, randomized placebo-controlled trial of the new technique for Achilles tendinopathy, results from a small study suggest.

The treatment also delivered no more patient satisfaction than placebo injections, nor did it facilitate a return to sports activity.

“These findings are important and clinically relevant as PRP is thought to be growing in popularity, and recent reviews supported its use for chronic tendon disorders,” said Dr. Robert J. de Vos of Erasmus University Medical Center, Rotterdam, the Netherlands, and his associates (JAMA 2010;303:144–9).

Platelet-rich plasma injections “raised high expectations” when they were introduced because PRP contains several growth factors that are known to play a role in tissue repair.

It was thought that relatively high concentrations of vascular endothelial growth factor, platelet-derived growth factor, and transforming growth factor–beta could help regenerate tendon tissue “through increased tendon cell proliferation, collagen synthesis, and vascularization.”

In their trial, Dr. de Vos and his colleagues compared PRP injections with placebo injections in 54 patients who were treated at the sports medicine outpatient department of a single large hospital for chronic midportion Achilles tendinopathy.

The pain was located approximately 2–7 cm proximal to the tendon's insertion on the calcaneus.

The tendon structure was examined using ultrasound, and the fluid was injected through three puncture locations. Five small depots were left at each location, within the degenerative area of the main body of the tendon.

All subjects underwent a standard rehabilitation program that included daily stretching and eccentric exercises—primarily “heel drops” performed on a step, which stretched the Achilles tendon while concurrently contracting the calf muscle.

At 6, 12, and 24 weeks' follow-up, scores were no different between the 27 patients who received active injections and the 27 who received placebo injections, on a measure of pain and activity specifically addressing Achilles tendinopathy.

Subjective patient satisfaction also was not significantly different between the two groups, according to the results. The same was true for the number of subjects able to return to their desired sport after 24 weeks.

The use of PRP injections in clinical practice has been based on the findings of laboratory studies and a few small clinical studies that did not include a proper control group and were not blinded, Dr. de Vos and his associates noted.

Given the results of their clinical trial, “we do not recommend this treatment for chronic midportion Achilles tendinopathy,” they said.

Major Finding: Patients with chronic midportion Achilles tendinopathy received no benefit from injections of platelet-rich plasma (PRP).

Data Source: In a blinded, randomized, placebo-controlled trial, 27 patients were treated with PRP injections and 27 were treated with placebo injections.

Disclosures: Funded by Biomet Biologics. No other disclosures were reported.

Injections of platelet-rich plasma failed to improve pain or function in the first blinded, randomized placebo-controlled trial of the new technique for Achilles tendinopathy, results from a small study suggest.

The treatment also delivered no more patient satisfaction than placebo injections, nor did it facilitate a return to sports activity.

“These findings are important and clinically relevant as PRP is thought to be growing in popularity, and recent reviews supported its use for chronic tendon disorders,” said Dr. Robert J. de Vos of Erasmus University Medical Center, Rotterdam, the Netherlands, and his associates (JAMA 2010;303:144–9).

Platelet-rich plasma injections “raised high expectations” when they were introduced because PRP contains several growth factors that are known to play a role in tissue repair.

It was thought that relatively high concentrations of vascular endothelial growth factor, platelet-derived growth factor, and transforming growth factor–beta could help regenerate tendon tissue “through increased tendon cell proliferation, collagen synthesis, and vascularization.”

In their trial, Dr. de Vos and his colleagues compared PRP injections with placebo injections in 54 patients who were treated at the sports medicine outpatient department of a single large hospital for chronic midportion Achilles tendinopathy.

The pain was located approximately 2–7 cm proximal to the tendon's insertion on the calcaneus.

The tendon structure was examined using ultrasound, and the fluid was injected through three puncture locations. Five small depots were left at each location, within the degenerative area of the main body of the tendon.

All subjects underwent a standard rehabilitation program that included daily stretching and eccentric exercises—primarily “heel drops” performed on a step, which stretched the Achilles tendon while concurrently contracting the calf muscle.

At 6, 12, and 24 weeks' follow-up, scores were no different between the 27 patients who received active injections and the 27 who received placebo injections, on a measure of pain and activity specifically addressing Achilles tendinopathy.

Subjective patient satisfaction also was not significantly different between the two groups, according to the results. The same was true for the number of subjects able to return to their desired sport after 24 weeks.

The use of PRP injections in clinical practice has been based on the findings of laboratory studies and a few small clinical studies that did not include a proper control group and were not blinded, Dr. de Vos and his associates noted.

Given the results of their clinical trial, “we do not recommend this treatment for chronic midportion Achilles tendinopathy,” they said.

Major Finding: 37% of wives whose husbands were deployed received a mental health diagnosis, compared with 30% of wives whose husbands were not deployed.

Data Source: Records of all outpatient medical visits of wives of active-duty Army personnel between 2003 and 2006.

Disclosures: Dr. Mansfield reported no conflicts, but a coauthor reported relationships with Bristol-Myers Squibb and Novartis. Dr. Friedman had no relevant disclosures.

Wives of U.S. soldiers deployed to Iraq or Afghanistan for prolonged periods are at increased risk for receiving mental health diagnoses, compared with wives of nondeployed personnel, according to a recent report.

The higher risk was most apparent for depressive, anxiety, sleep, and acute stress reaction and adjustment disorders, said Alyssa J. Mansfield, Ph.D., of the University of North Carolina, Chapel Hill, and her associates.

“Overall, our data suggest that the mental health effects of current operations are extending beyond soldiers and into their immediate families,” the investigators noted.

Dr. Mansfield and her colleagues examined the records of all outpatient medical visits by wives of active-duty Army personnel between 2003 and 2006. This included wives who were treated at military facilities and those who were treated at nonmilitary health centers but used military medical insurance.

Only wives of members of the military who had been in active-duty service for at least 5 years were included in the study “to establish a recent mental health history.”

The study sample included 250,626 women who made 6,585,224 outpatient medical visits. Seventeen categories of mental health disorders were assessed. A total of 35% of these wives received at least one mental health diagnosis during the 4-year study.

A total of 37% of wives whose husbands were deployed received a mental health diagnosis, compared with 30% of wives whose husbands were not deployed, the researchers said (N. Engl. J. Med. 2010;362:101–9).

Wives of men who were deployed showed rates of diagnosis that were 24% higher for depressive disorders, 21%–40% higher for sleep disorders, 25%–29% higher for anxiety disorders, and 23%–39% higher for acute stress reaction and adjustment disorders, compared with wives of nondeployed men.

The rate of mental health diagnosis was significantly associated with length of husbands' deployment. Compared with wives of men who were not deployed, wives of men deployed for up to 11 months used mental health services 19% more often, and wives of men deployed for more than 11 months used mental health services 27% more often.

There were 41 excess cases of any mental health disorder (per 1,000 wives) associated with deployments of 1–11 months, and 61 excess cases of any mental health disorder associated with deployments of more than 11 months.

This represents 3,474 excess mental health diagnoses among nearly 85,000 wives of men deployed for less than 11 months and 5,370 excess mental health diagnoses among more than 88,000 wives of men deployed for a longer period.

“Because the majority of active-duty Army soldiers are married, and they and their families will eventually receive care outside the military medical system, both the short-term and long-term effects of these findings should be considered” by health care providers both inside and outside of the military, Dr. Mansfield and her associates said.

In an editorial comment accompanying this report, Dr. Matthew J. Friedman of the Veterans Affairs Medical Center in White River Junction, Vt., said the study findings highlight the importance of “developing appropriate programs to fortify wellness and resilience among spouses and children.”

“Since social support provides the strongest protection against the development of psychiatric disorders, and since the family is the major source of social support, improvement in the mental health of spouses and children should also pay dividends in improving the mental health of troops throughout the deployment cycle,” Dr. Friedman said (N. Engl. J. Med. 2010:362;168–70).

Major Finding: 37% of wives whose husbands were deployed received a mental health diagnosis, compared with 30% of wives whose husbands were not deployed.

Data Source: Records of all outpatient medical visits of wives of active-duty Army personnel between 2003 and 2006.

Disclosures: Dr. Mansfield reported no conflicts, but a coauthor reported relationships with Bristol-Myers Squibb and Novartis. Dr. Friedman had no relevant disclosures.

Wives of U.S. soldiers deployed to Iraq or Afghanistan for prolonged periods are at increased risk for receiving mental health diagnoses, compared with wives of nondeployed personnel, according to a recent report.

The higher risk was most apparent for depressive, anxiety, sleep, and acute stress reaction and adjustment disorders, said Alyssa J. Mansfield, Ph.D., of the University of North Carolina, Chapel Hill, and her associates.

“Overall, our data suggest that the mental health effects of current operations are extending beyond soldiers and into their immediate families,” the investigators noted.

Dr. Mansfield and her colleagues examined the records of all outpatient medical visits by wives of active-duty Army personnel between 2003 and 2006. This included wives who were treated at military facilities and those who were treated at nonmilitary health centers but used military medical insurance.

Only wives of members of the military who had been in active-duty service for at least 5 years were included in the study “to establish a recent mental health history.”

The study sample included 250,626 women who made 6,585,224 outpatient medical visits. Seventeen categories of mental health disorders were assessed. A total of 35% of these wives received at least one mental health diagnosis during the 4-year study.

A total of 37% of wives whose husbands were deployed received a mental health diagnosis, compared with 30% of wives whose husbands were not deployed, the researchers said (N. Engl. J. Med. 2010;362:101–9).

Wives of men who were deployed showed rates of diagnosis that were 24% higher for depressive disorders, 21%–40% higher for sleep disorders, 25%–29% higher for anxiety disorders, and 23%–39% higher for acute stress reaction and adjustment disorders, compared with wives of nondeployed men.

The rate of mental health diagnosis was significantly associated with length of husbands' deployment. Compared with wives of men who were not deployed, wives of men deployed for up to 11 months used mental health services 19% more often, and wives of men deployed for more than 11 months used mental health services 27% more often.

There were 41 excess cases of any mental health disorder (per 1,000 wives) associated with deployments of 1–11 months, and 61 excess cases of any mental health disorder associated with deployments of more than 11 months.

This represents 3,474 excess mental health diagnoses among nearly 85,000 wives of men deployed for less than 11 months and 5,370 excess mental health diagnoses among more than 88,000 wives of men deployed for a longer period.

“Because the majority of active-duty Army soldiers are married, and they and their families will eventually receive care outside the military medical system, both the short-term and long-term effects of these findings should be considered” by health care providers both inside and outside of the military, Dr. Mansfield and her associates said.

In an editorial comment accompanying this report, Dr. Matthew J. Friedman of the Veterans Affairs Medical Center in White River Junction, Vt., said the study findings highlight the importance of “developing appropriate programs to fortify wellness and resilience among spouses and children.”

“Since social support provides the strongest protection against the development of psychiatric disorders, and since the family is the major source of social support, improvement in the mental health of spouses and children should also pay dividends in improving the mental health of troops throughout the deployment cycle,” Dr. Friedman said (N. Engl. J. Med. 2010:362;168–70).

Major Finding: 37% of wives whose husbands were deployed received a mental health diagnosis, compared with 30% of wives whose husbands were not deployed.

Data Source: Records of all outpatient medical visits of wives of active-duty Army personnel between 2003 and 2006.

Disclosures: Dr. Mansfield reported no conflicts, but a coauthor reported relationships with Bristol-Myers Squibb and Novartis. Dr. Friedman had no relevant disclosures.

Wives of U.S. soldiers deployed to Iraq or Afghanistan for prolonged periods are at increased risk for receiving mental health diagnoses, compared with wives of nondeployed personnel, according to a recent report.

The higher risk was most apparent for depressive, anxiety, sleep, and acute stress reaction and adjustment disorders, said Alyssa J. Mansfield, Ph.D., of the University of North Carolina, Chapel Hill, and her associates.

“Overall, our data suggest that the mental health effects of current operations are extending beyond soldiers and into their immediate families,” the investigators noted.

Dr. Mansfield and her colleagues examined the records of all outpatient medical visits by wives of active-duty Army personnel between 2003 and 2006. This included wives who were treated at military facilities and those who were treated at nonmilitary health centers but used military medical insurance.

Only wives of members of the military who had been in active-duty service for at least 5 years were included in the study “to establish a recent mental health history.”

The study sample included 250,626 women who made 6,585,224 outpatient medical visits. Seventeen categories of mental health disorders were assessed. A total of 35% of these wives received at least one mental health diagnosis during the 4-year study.

A total of 37% of wives whose husbands were deployed received a mental health diagnosis, compared with 30% of wives whose husbands were not deployed, the researchers said (N. Engl. J. Med. 2010;362:101–9).

Wives of men who were deployed showed rates of diagnosis that were 24% higher for depressive disorders, 21%–40% higher for sleep disorders, 25%–29% higher for anxiety disorders, and 23%–39% higher for acute stress reaction and adjustment disorders, compared with wives of nondeployed men.

The rate of mental health diagnosis was significantly associated with length of husbands' deployment. Compared with wives of men who were not deployed, wives of men deployed for up to 11 months used mental health services 19% more often, and wives of men deployed for more than 11 months used mental health services 27% more often.

There were 41 excess cases of any mental health disorder (per 1,000 wives) associated with deployments of 1–11 months, and 61 excess cases of any mental health disorder associated with deployments of more than 11 months.

This represents 3,474 excess mental health diagnoses among nearly 85,000 wives of men deployed for less than 11 months and 5,370 excess mental health diagnoses among more than 88,000 wives of men deployed for a longer period.

“Because the majority of active-duty Army soldiers are married, and they and their families will eventually receive care outside the military medical system, both the short-term and long-term effects of these findings should be considered” by health care providers both inside and outside of the military, Dr. Mansfield and her associates said.

In an editorial comment accompanying this report, Dr. Matthew J. Friedman of the Veterans Affairs Medical Center in White River Junction, Vt., said the study findings highlight the importance of “developing appropriate programs to fortify wellness and resilience among spouses and children.”

“Since social support provides the strongest protection against the development of psychiatric disorders, and since the family is the major source of social support, improvement in the mental health of spouses and children should also pay dividends in improving the mental health of troops throughout the deployment cycle,” Dr. Friedman said (N. Engl. J. Med. 2010:362;168–70).