Heidi Splete

The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.

© timur1970/Fotolia.com

The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.

Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.

“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.

Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.

The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.

“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.

In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.

Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.

The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.

The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.

“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.

“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.

For further information, see the FDA’s full analysis of e-cigarettes.

The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.

© timur1970/Fotolia.com

The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.

Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.

“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.

Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.

The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.

“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.

In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.

Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.

The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.

The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.

“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.

“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.

For further information, see the FDA’s full analysis of e-cigarettes.

The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.

© timur1970/Fotolia.com

The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.

Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.

“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.

Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.

The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.

“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.

In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.

Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.

The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.

The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.

“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.

“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.

For further information, see the FDA’s full analysis of e-cigarettes.

Major Finding: Individuals in the highest tertile for cardiac index (indicating healthier heart function) had 0.35% and 0.36% greater total brain volume than did individuals in the middle and lowest tertiles, respectively.

Data Source: A cross-sectional review of brain and heart MRI data from 1,504 adults in the Framingham Offspring Cohort.

Disclosures: None of the investigators had financial conflicts to disclose. The research was supported in part by grants from the National Heart, Lung, and Blood Institute's Framingham Heart Study.

Reduced heart function might be associated with signs of preclinical brain aging, based on a review of data from the observational Framingham Heart Study.

Investigators led by Angela Jefferson, Ph.D., of Boston University, found that cardiac output, adjusted for body size, was significantly associated with the rate of change in brain volume as the study participants aged.

Because initial research studies on the effects of cardiac output on brain aging were conducted on small samples of referred patients with clinical cardiovascular disease and were not systematically adjusted for environmental risk factors known to contribute to both central nervous system and myocardial injury, Dr. Jefferson and her colleagues sought to determine if the relationship existed in patients who were free of clinical dementia or stroke. On the basis of previous findings from animal and clinical studies, they “hypothesized that MRI-assessed cardiac function is associated with cognitive and neuroimaging markers of preclinical Alzheimer's disease and cerebrovascular disease.”

The investigators reviewed brain and heart MRI data from 1,504 adults aged 34-84 years, excluding individuals with a documented history of clinical stroke, transient ischemic attack, or dementia. The average age was 61 years; 54% were women. In the ongoing study, participants are assessed every 4-8 years (Circulation 2010 Aug. 2 [doi:10.1161/circulationaha.109.905091]).

Low cardiac index (defined as less than 2.5 L/min per m

The researchers found that for every one standard deviation increase in cardiac index, the total brain volume (measured as a percentage of total cranial volume) increased by 0.30%. Cardiac index also increased as lateral ventricular volume decreased, but this relationship was not significant when individuals with cardiovascular disease were excluded.

In a post hoc analysis, the researchers compared cardiac index tertiles and changes in brain volume. They used the highest tertile as the referent, given that higher cardiac index values reflect healthier heart function.

Individuals in the middle tertile for cardiac index had an average total brain volume that was 0.35% less than that of those in the top tertile. Those in the bottom tertile had average total brain volume of 0.36% less than that of those in the top tertile. These changes corresponded to an average difference in brain aging of 1.9 years (a total brain volume decrease of 0.19% per 1-year increase in age).

Cardiac index as a continuous variable was not significantly related to any of the neuropsychological factor scores. But low executive function and information processing nearly reached statistical significance in association with low cardiac index.

The association between cardiac index and brain volume was significantly stronger among adults who were younger than 60 years, compared with older adults, and in men compared with women. However, the association was not significantly modified by apolipoprotein E e4 allele status.

The results were limited by the observational nature of the study, which cannot establish causality.

However, the findings were consistent with the hypothesis that decreasing cardiac function is associated with accelerated brain aging, and suggest that low and low-normal cardiac index values might be related to brain health, as measured by brain volume, the investigators said.

My Take

Study Results Strong, but Not Definitive

Teasing out the role of brain volume in cognitive function is a challenge, as early cognitive changes are often minimal.

In this study by Dr. Jefferson and her associates, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.

It is not clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. Previous data indicate that vascular risk factors can contribute to dementia. More research is needed in “vascular cognitive disorders,” a newly identified term describing conditions “in which vascular damage plays a role, either alone or in combination with a neurodegenerative or other process, in the development of cognitive impairment or dementia,” to explore how addressing vascular risk factors could modify the course of different types of dementias.

CLINTON B. WRIGHT, M.D., and RALPH L. SACCO, M.D., are in the department of neurology at the University of Miami. Their comments are paraphrased from an editorial (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]). They had no financial conflicts to disclose.

Major Finding: Individuals in the highest tertile for cardiac index (indicating healthier heart function) had 0.35% and 0.36% greater total brain volume than did individuals in the middle and lowest tertiles, respectively.

Data Source: A cross-sectional review of brain and heart MRI data from 1,504 adults in the Framingham Offspring Cohort.

Disclosures: None of the investigators had financial conflicts to disclose. The research was supported in part by grants from the National Heart, Lung, and Blood Institute's Framingham Heart Study.

Reduced heart function might be associated with signs of preclinical brain aging, based on a review of data from the observational Framingham Heart Study.

Investigators led by Angela Jefferson, Ph.D., of Boston University, found that cardiac output, adjusted for body size, was significantly associated with the rate of change in brain volume as the study participants aged.

Because initial research studies on the effects of cardiac output on brain aging were conducted on small samples of referred patients with clinical cardiovascular disease and were not systematically adjusted for environmental risk factors known to contribute to both central nervous system and myocardial injury, Dr. Jefferson and her colleagues sought to determine if the relationship existed in patients who were free of clinical dementia or stroke. On the basis of previous findings from animal and clinical studies, they “hypothesized that MRI-assessed cardiac function is associated with cognitive and neuroimaging markers of preclinical Alzheimer's disease and cerebrovascular disease.”

The investigators reviewed brain and heart MRI data from 1,504 adults aged 34-84 years, excluding individuals with a documented history of clinical stroke, transient ischemic attack, or dementia. The average age was 61 years; 54% were women. In the ongoing study, participants are assessed every 4-8 years (Circulation 2010 Aug. 2 [doi:10.1161/circulationaha.109.905091]).

Low cardiac index (defined as less than 2.5 L/min per m

The researchers found that for every one standard deviation increase in cardiac index, the total brain volume (measured as a percentage of total cranial volume) increased by 0.30%. Cardiac index also increased as lateral ventricular volume decreased, but this relationship was not significant when individuals with cardiovascular disease were excluded.

In a post hoc analysis, the researchers compared cardiac index tertiles and changes in brain volume. They used the highest tertile as the referent, given that higher cardiac index values reflect healthier heart function.

Individuals in the middle tertile for cardiac index had an average total brain volume that was 0.35% less than that of those in the top tertile. Those in the bottom tertile had average total brain volume of 0.36% less than that of those in the top tertile. These changes corresponded to an average difference in brain aging of 1.9 years (a total brain volume decrease of 0.19% per 1-year increase in age).

Cardiac index as a continuous variable was not significantly related to any of the neuropsychological factor scores. But low executive function and information processing nearly reached statistical significance in association with low cardiac index.

The association between cardiac index and brain volume was significantly stronger among adults who were younger than 60 years, compared with older adults, and in men compared with women. However, the association was not significantly modified by apolipoprotein E e4 allele status.

The results were limited by the observational nature of the study, which cannot establish causality.

However, the findings were consistent with the hypothesis that decreasing cardiac function is associated with accelerated brain aging, and suggest that low and low-normal cardiac index values might be related to brain health, as measured by brain volume, the investigators said.

My Take

Study Results Strong, but Not Definitive

Teasing out the role of brain volume in cognitive function is a challenge, as early cognitive changes are often minimal.

In this study by Dr. Jefferson and her associates, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.

It is not clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. Previous data indicate that vascular risk factors can contribute to dementia. More research is needed in “vascular cognitive disorders,” a newly identified term describing conditions “in which vascular damage plays a role, either alone or in combination with a neurodegenerative or other process, in the development of cognitive impairment or dementia,” to explore how addressing vascular risk factors could modify the course of different types of dementias.

CLINTON B. WRIGHT, M.D., and RALPH L. SACCO, M.D., are in the department of neurology at the University of Miami. Their comments are paraphrased from an editorial (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]). They had no financial conflicts to disclose.

Major Finding: Individuals in the highest tertile for cardiac index (indicating healthier heart function) had 0.35% and 0.36% greater total brain volume than did individuals in the middle and lowest tertiles, respectively.

Data Source: A cross-sectional review of brain and heart MRI data from 1,504 adults in the Framingham Offspring Cohort.

Disclosures: None of the investigators had financial conflicts to disclose. The research was supported in part by grants from the National Heart, Lung, and Blood Institute's Framingham Heart Study.

Reduced heart function might be associated with signs of preclinical brain aging, based on a review of data from the observational Framingham Heart Study.

Investigators led by Angela Jefferson, Ph.D., of Boston University, found that cardiac output, adjusted for body size, was significantly associated with the rate of change in brain volume as the study participants aged.

Because initial research studies on the effects of cardiac output on brain aging were conducted on small samples of referred patients with clinical cardiovascular disease and were not systematically adjusted for environmental risk factors known to contribute to both central nervous system and myocardial injury, Dr. Jefferson and her colleagues sought to determine if the relationship existed in patients who were free of clinical dementia or stroke. On the basis of previous findings from animal and clinical studies, they “hypothesized that MRI-assessed cardiac function is associated with cognitive and neuroimaging markers of preclinical Alzheimer's disease and cerebrovascular disease.”

The investigators reviewed brain and heart MRI data from 1,504 adults aged 34-84 years, excluding individuals with a documented history of clinical stroke, transient ischemic attack, or dementia. The average age was 61 years; 54% were women. In the ongoing study, participants are assessed every 4-8 years (Circulation 2010 Aug. 2 [doi:10.1161/circulationaha.109.905091]).

Low cardiac index (defined as less than 2.5 L/min per m

The researchers found that for every one standard deviation increase in cardiac index, the total brain volume (measured as a percentage of total cranial volume) increased by 0.30%. Cardiac index also increased as lateral ventricular volume decreased, but this relationship was not significant when individuals with cardiovascular disease were excluded.

In a post hoc analysis, the researchers compared cardiac index tertiles and changes in brain volume. They used the highest tertile as the referent, given that higher cardiac index values reflect healthier heart function.

Individuals in the middle tertile for cardiac index had an average total brain volume that was 0.35% less than that of those in the top tertile. Those in the bottom tertile had average total brain volume of 0.36% less than that of those in the top tertile. These changes corresponded to an average difference in brain aging of 1.9 years (a total brain volume decrease of 0.19% per 1-year increase in age).

Cardiac index as a continuous variable was not significantly related to any of the neuropsychological factor scores. But low executive function and information processing nearly reached statistical significance in association with low cardiac index.

The association between cardiac index and brain volume was significantly stronger among adults who were younger than 60 years, compared with older adults, and in men compared with women. However, the association was not significantly modified by apolipoprotein E e4 allele status.

The results were limited by the observational nature of the study, which cannot establish causality.

However, the findings were consistent with the hypothesis that decreasing cardiac function is associated with accelerated brain aging, and suggest that low and low-normal cardiac index values might be related to brain health, as measured by brain volume, the investigators said.

My Take

Study Results Strong, but Not Definitive

Teasing out the role of brain volume in cognitive function is a challenge, as early cognitive changes are often minimal.

In this study by Dr. Jefferson and her associates, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.

It is not clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. Previous data indicate that vascular risk factors can contribute to dementia. More research is needed in “vascular cognitive disorders,” a newly identified term describing conditions “in which vascular damage plays a role, either alone or in combination with a neurodegenerative or other process, in the development of cognitive impairment or dementia,” to explore how addressing vascular risk factors could modify the course of different types of dementias.

CLINTON B. WRIGHT, M.D., and RALPH L. SACCO, M.D., are in the department of neurology at the University of Miami. Their comments are paraphrased from an editorial (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]). They had no financial conflicts to disclose.

Major Finding: In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively).

Data Source: A subset of patients totaling 775 from two safety and efficacy studies of aliskiren/hydrochlorothiazide.

Disclosures: Novartis Pharmaceuticals supported the study. Dr. Ferdinand had no financial conflicts to disclose, but one of the study coauthors is an employee of Novartis Pharmaceuticals.

CRYSTAL CITY, VA. — Aliskiren in combination with either hydrochlorothiazide or amlodipine reduced central systolic blood pressure significantly more than did amlodipine alone in an African American population, based on data from two studies of several hundred adults.

Findings from previous studies have suggested that cardiovascular morbidity might be more closely associated with central blood pressure than it is with systolic blood pressure, according to Dr. Keith Ferdinand of Emory University in Atlanta, and his colleagues.

Additional studies have shown that central blood pressure tends to be higher in healthy young African American men, compared with that in healthy young white men, the researchers noted in a poster at the meeting.

To compare the effects of a combination aliskiren/hydrochlorothiazide (HCTZ) in African Americans with stage II hypertension, Dr. Ferdinand and his colleagues reviewed a subset of patients from two safety and efficacy studies of aliskiren/HCTZ.

Overall, central systolic blood pressure was reduced by approximately 30 mm Hg from baseline in each study, the researchers said, which suggests that aliskiren combined with either a diuretic or calcium channel blocker might be equally effective in African American patients.

In study 1, which included 53 sites throughout the United States, 166 patients were randomized to 300 mg aliskiren/25 mg HCTZ, and 166 received 10 mg amlodipine.

In study 2, a total of 220 adults were randomized to receive 300 mg aliskiren/10 mg amlodipine, and 223 received 10 mg amlodipine.

In study 1, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/HCTZ group, compared with the amlodipine-only group (30.1 mm Hg and 21.2 mm Hg, respectively) after 8 weeks of treatment, the researchers noted.

Changes in the peripheral measure of systolic blood pressure were not significant in either of the groups.

In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in patients in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively).

But in this study, the mean reduction in the peripheral measure of systolic blood pressure also was significant (34.1 mm Hg and 28.9 mm Hg, respectively).

Aliskiren-based combination therapy also reduced diastolic blood pressure in both studies, but the mean reductions only reached significance in study 2. In that study, the mean reductions in the central measure of diastolic blood pressure in the aliskiren/amlodipine group and the amlodipine-only group were 16.0 mm Hg vs. 9.9 mm Hg, respectively, and the mean reductions in the peripheral measure of diastolic blood pressure for the two groups were 14.3 mm Hg and 10.5 mm Hg, respectively.

The average age of the patients was 53 years, and approximately half were women.

Patients with type 1 diabetes or type 2 diabetes who took insulin were excluded, as were patients with a history of heart failure, myocardial infarction, or other heart problems within a year of the study.

Reports of adverse events were similar between the two groups in each study, and the most common adverse events included headache, diarrhea, nausea, hypokalemia, nasopharyngitis, upper respiratory tract infection, peripheral edema, and pain.

Major Finding: In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively).

Data Source: A subset of patients totaling 775 from two safety and efficacy studies of aliskiren/hydrochlorothiazide.

Disclosures: Novartis Pharmaceuticals supported the study. Dr. Ferdinand had no financial conflicts to disclose, but one of the study coauthors is an employee of Novartis Pharmaceuticals.

CRYSTAL CITY, VA. — Aliskiren in combination with either hydrochlorothiazide or amlodipine reduced central systolic blood pressure significantly more than did amlodipine alone in an African American population, based on data from two studies of several hundred adults.

Findings from previous studies have suggested that cardiovascular morbidity might be more closely associated with central blood pressure than it is with systolic blood pressure, according to Dr. Keith Ferdinand of Emory University in Atlanta, and his colleagues.

Additional studies have shown that central blood pressure tends to be higher in healthy young African American men, compared with that in healthy young white men, the researchers noted in a poster at the meeting.

To compare the effects of a combination aliskiren/hydrochlorothiazide (HCTZ) in African Americans with stage II hypertension, Dr. Ferdinand and his colleagues reviewed a subset of patients from two safety and efficacy studies of aliskiren/HCTZ.

Overall, central systolic blood pressure was reduced by approximately 30 mm Hg from baseline in each study, the researchers said, which suggests that aliskiren combined with either a diuretic or calcium channel blocker might be equally effective in African American patients.

In study 1, which included 53 sites throughout the United States, 166 patients were randomized to 300 mg aliskiren/25 mg HCTZ, and 166 received 10 mg amlodipine.

In study 2, a total of 220 adults were randomized to receive 300 mg aliskiren/10 mg amlodipine, and 223 received 10 mg amlodipine.

In study 1, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/HCTZ group, compared with the amlodipine-only group (30.1 mm Hg and 21.2 mm Hg, respectively) after 8 weeks of treatment, the researchers noted.

Changes in the peripheral measure of systolic blood pressure were not significant in either of the groups.

In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in patients in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively).

But in this study, the mean reduction in the peripheral measure of systolic blood pressure also was significant (34.1 mm Hg and 28.9 mm Hg, respectively).

Aliskiren-based combination therapy also reduced diastolic blood pressure in both studies, but the mean reductions only reached significance in study 2. In that study, the mean reductions in the central measure of diastolic blood pressure in the aliskiren/amlodipine group and the amlodipine-only group were 16.0 mm Hg vs. 9.9 mm Hg, respectively, and the mean reductions in the peripheral measure of diastolic blood pressure for the two groups were 14.3 mm Hg and 10.5 mm Hg, respectively.

The average age of the patients was 53 years, and approximately half were women.

Patients with type 1 diabetes or type 2 diabetes who took insulin were excluded, as were patients with a history of heart failure, myocardial infarction, or other heart problems within a year of the study.

Reports of adverse events were similar between the two groups in each study, and the most common adverse events included headache, diarrhea, nausea, hypokalemia, nasopharyngitis, upper respiratory tract infection, peripheral edema, and pain.

Major Finding: In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively).

Data Source: A subset of patients totaling 775 from two safety and efficacy studies of aliskiren/hydrochlorothiazide.

Disclosures: Novartis Pharmaceuticals supported the study. Dr. Ferdinand had no financial conflicts to disclose, but one of the study coauthors is an employee of Novartis Pharmaceuticals.

CRYSTAL CITY, VA. — Aliskiren in combination with either hydrochlorothiazide or amlodipine reduced central systolic blood pressure significantly more than did amlodipine alone in an African American population, based on data from two studies of several hundred adults.

Findings from previous studies have suggested that cardiovascular morbidity might be more closely associated with central blood pressure than it is with systolic blood pressure, according to Dr. Keith Ferdinand of Emory University in Atlanta, and his colleagues.

Additional studies have shown that central blood pressure tends to be higher in healthy young African American men, compared with that in healthy young white men, the researchers noted in a poster at the meeting.

To compare the effects of a combination aliskiren/hydrochlorothiazide (HCTZ) in African Americans with stage II hypertension, Dr. Ferdinand and his colleagues reviewed a subset of patients from two safety and efficacy studies of aliskiren/HCTZ.

Overall, central systolic blood pressure was reduced by approximately 30 mm Hg from baseline in each study, the researchers said, which suggests that aliskiren combined with either a diuretic or calcium channel blocker might be equally effective in African American patients.

In study 1, which included 53 sites throughout the United States, 166 patients were randomized to 300 mg aliskiren/25 mg HCTZ, and 166 received 10 mg amlodipine.

In study 2, a total of 220 adults were randomized to receive 300 mg aliskiren/10 mg amlodipine, and 223 received 10 mg amlodipine.

In study 1, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/HCTZ group, compared with the amlodipine-only group (30.1 mm Hg and 21.2 mm Hg, respectively) after 8 weeks of treatment, the researchers noted.

Changes in the peripheral measure of systolic blood pressure were not significant in either of the groups.

In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in patients in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively).

But in this study, the mean reduction in the peripheral measure of systolic blood pressure also was significant (34.1 mm Hg and 28.9 mm Hg, respectively).

Aliskiren-based combination therapy also reduced diastolic blood pressure in both studies, but the mean reductions only reached significance in study 2. In that study, the mean reductions in the central measure of diastolic blood pressure in the aliskiren/amlodipine group and the amlodipine-only group were 16.0 mm Hg vs. 9.9 mm Hg, respectively, and the mean reductions in the peripheral measure of diastolic blood pressure for the two groups were 14.3 mm Hg and 10.5 mm Hg, respectively.

The average age of the patients was 53 years, and approximately half were women.

Patients with type 1 diabetes or type 2 diabetes who took insulin were excluded, as were patients with a history of heart failure, myocardial infarction, or other heart problems within a year of the study.

Reports of adverse events were similar between the two groups in each study, and the most common adverse events included headache, diarrhea, nausea, hypokalemia, nasopharyngitis, upper respiratory tract infection, peripheral edema, and pain.

Approximately 40% of emergency department visits for sports-related concussions in young athletes occurred in children aged 8-13 years, based on data from concussion-related ED visits in the United States between 2001 and 2005, according to a study published online Aug. 30 in Pediatrics.

©james boulette/iStockphoto.com

There are two main concerns about sports-related concussion in younger children, compared with college athletes and adults, lead study author Dr. Lisa Bakhos of Brown University, Providence, R.I., said in an interview.

“First, many parents, coaches, teachers, and other adults feel that, because these athletes are so young, they could not possibly get seriously hurt. As we have seen time and time again, this is of course not the case,” she said.

“Also, a few good studies have shown that head injury in younger children can have more long-term effects, as you are essentially damaging a developing brain,” she explained. In addition, more data have surfaced about cognitive deficits in older children after concussion, she said, “which leads to conjecture that younger children would suffer the same, if not more, deficits long term.” However, the link between sports-related concussion and cognitive deficits needs further study, she added.

To get a better picture of the scope of sports-related concussion in young athletes, Dr. Bakhos and colleagues reviewed data from the National Electronic Injury Surveillance System (NEISS) from 1997 through 2007, and from the NEISS All Injury Program from 2001 through 2005. The NEISS allows researchers to investigate injury- and product-related ED visits (Pediatrics 2010 Aug. 30 [doi:10.1542/peds.2009-3101]).

Between 2001 and 2005, approximately half of all ED visits for concussion across older and younger age groups were related to sports, including 58% visits in children aged 8-13 years and 46% of visits in those aged 14-19 years. Put another way, approximately 4 in 1,000 children aged 8-13 years and 6 in 1,000 of those aged 14-19 years went to the ED for a sports-related concussion.

During the 10-year period from 1997 through 2007, ED visits for the most popular organized team sports – football, ice hockey, soccer, basketball, and baseball – doubled in 8- to 13-year-olds and increased by more than 200% in 14- to 19-year-olds.

“The take-home message for pediatricians is take concussion seriously even in the very young athlete,” said Dr. Bakhos. “Children with concussion should be followed just as closely as a child with a sprained ankle or a broken bone. Return-to-play guidelines should be followed closely and stressed to parents,” she said.

“We as pediatricians should also stress to parents the importance of concussion prevention in sport as well, mostly the use of helmets at all times,” she emphasized.

The study was limited by the exclusion of sports-related concussions treated in non-ED settings, and by the underreporting of sports-related concussions by young athletes, their parents, and their coaches, the researchers noted.

But the rise in sports-related concussions in younger and older children suggests the need for more research and guidance in preventing and treating these injuries, they added.

The researchers said that they had no financial conflicts to disclose.

Approximately 40% of emergency department visits for sports-related concussions in young athletes occurred in children aged 8-13 years, based on data from concussion-related ED visits in the United States between 2001 and 2005, according to a study published online Aug. 30 in Pediatrics.

©james boulette/iStockphoto.com

There are two main concerns about sports-related concussion in younger children, compared with college athletes and adults, lead study author Dr. Lisa Bakhos of Brown University, Providence, R.I., said in an interview.

“First, many parents, coaches, teachers, and other adults feel that, because these athletes are so young, they could not possibly get seriously hurt. As we have seen time and time again, this is of course not the case,” she said.

“Also, a few good studies have shown that head injury in younger children can have more long-term effects, as you are essentially damaging a developing brain,” she explained. In addition, more data have surfaced about cognitive deficits in older children after concussion, she said, “which leads to conjecture that younger children would suffer the same, if not more, deficits long term.” However, the link between sports-related concussion and cognitive deficits needs further study, she added.

To get a better picture of the scope of sports-related concussion in young athletes, Dr. Bakhos and colleagues reviewed data from the National Electronic Injury Surveillance System (NEISS) from 1997 through 2007, and from the NEISS All Injury Program from 2001 through 2005. The NEISS allows researchers to investigate injury- and product-related ED visits (Pediatrics 2010 Aug. 30 [doi:10.1542/peds.2009-3101]).

Between 2001 and 2005, approximately half of all ED visits for concussion across older and younger age groups were related to sports, including 58% visits in children aged 8-13 years and 46% of visits in those aged 14-19 years. Put another way, approximately 4 in 1,000 children aged 8-13 years and 6 in 1,000 of those aged 14-19 years went to the ED for a sports-related concussion.

During the 10-year period from 1997 through 2007, ED visits for the most popular organized team sports – football, ice hockey, soccer, basketball, and baseball – doubled in 8- to 13-year-olds and increased by more than 200% in 14- to 19-year-olds.

“The take-home message for pediatricians is take concussion seriously even in the very young athlete,” said Dr. Bakhos. “Children with concussion should be followed just as closely as a child with a sprained ankle or a broken bone. Return-to-play guidelines should be followed closely and stressed to parents,” she said.

“We as pediatricians should also stress to parents the importance of concussion prevention in sport as well, mostly the use of helmets at all times,” she emphasized.

The study was limited by the exclusion of sports-related concussions treated in non-ED settings, and by the underreporting of sports-related concussions by young athletes, their parents, and their coaches, the researchers noted.

But the rise in sports-related concussions in younger and older children suggests the need for more research and guidance in preventing and treating these injuries, they added.

The researchers said that they had no financial conflicts to disclose.

Approximately 40% of emergency department visits for sports-related concussions in young athletes occurred in children aged 8-13 years, based on data from concussion-related ED visits in the United States between 2001 and 2005, according to a study published online Aug. 30 in Pediatrics.

©james boulette/iStockphoto.com

There are two main concerns about sports-related concussion in younger children, compared with college athletes and adults, lead study author Dr. Lisa Bakhos of Brown University, Providence, R.I., said in an interview.

“First, many parents, coaches, teachers, and other adults feel that, because these athletes are so young, they could not possibly get seriously hurt. As we have seen time and time again, this is of course not the case,” she said.

“Also, a few good studies have shown that head injury in younger children can have more long-term effects, as you are essentially damaging a developing brain,” she explained. In addition, more data have surfaced about cognitive deficits in older children after concussion, she said, “which leads to conjecture that younger children would suffer the same, if not more, deficits long term.” However, the link between sports-related concussion and cognitive deficits needs further study, she added.

To get a better picture of the scope of sports-related concussion in young athletes, Dr. Bakhos and colleagues reviewed data from the National Electronic Injury Surveillance System (NEISS) from 1997 through 2007, and from the NEISS All Injury Program from 2001 through 2005. The NEISS allows researchers to investigate injury- and product-related ED visits (Pediatrics 2010 Aug. 30 [doi:10.1542/peds.2009-3101]).

Between 2001 and 2005, approximately half of all ED visits for concussion across older and younger age groups were related to sports, including 58% visits in children aged 8-13 years and 46% of visits in those aged 14-19 years. Put another way, approximately 4 in 1,000 children aged 8-13 years and 6 in 1,000 of those aged 14-19 years went to the ED for a sports-related concussion.

During the 10-year period from 1997 through 2007, ED visits for the most popular organized team sports – football, ice hockey, soccer, basketball, and baseball – doubled in 8- to 13-year-olds and increased by more than 200% in 14- to 19-year-olds.

“The take-home message for pediatricians is take concussion seriously even in the very young athlete,” said Dr. Bakhos. “Children with concussion should be followed just as closely as a child with a sprained ankle or a broken bone. Return-to-play guidelines should be followed closely and stressed to parents,” she said.

“We as pediatricians should also stress to parents the importance of concussion prevention in sport as well, mostly the use of helmets at all times,” she emphasized.

The study was limited by the exclusion of sports-related concussions treated in non-ED settings, and by the underreporting of sports-related concussions by young athletes, their parents, and their coaches, the researchers noted.

But the rise in sports-related concussions in younger and older children suggests the need for more research and guidance in preventing and treating these injuries, they added.

The researchers said that they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis compared with nonblack patients, based on data from more than 7,000 adults published online Aug. 30 in Circulation.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008.

The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1 year, 2 years, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely than nonblack patients to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger than nonblack patients (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from previous studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Because our analysis adjusts for traditional variables associated with racial disparities in health care, further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

The researchers said that they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis compared with nonblack patients, based on data from more than 7,000 adults published online Aug. 30 in Circulation.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008.

The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1 year, 2 years, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely than nonblack patients to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger than nonblack patients (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from previous studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Because our analysis adjusts for traditional variables associated with racial disparities in health care, further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

The researchers said that they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis compared with nonblack patients, based on data from more than 7,000 adults published online Aug. 30 in Circulation.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008.

The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1 year, 2 years, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely than nonblack patients to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger than nonblack patients (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from previous studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Because our analysis adjusts for traditional variables associated with racial disparities in health care, further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

The researchers said that they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis compared with nonblack patients, based on data from more than 7,000 adults published online Aug. 30 in Circulation.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008.

The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1 year, 2 years, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely than nonblack patients to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger than nonblack patients (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from previous studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Because our analysis adjusts for traditional variables associated with racial disparities in health care, further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

The researchers said that they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis compared with nonblack patients, based on data from more than 7,000 adults published online Aug. 30 in Circulation.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008.

The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1 year, 2 years, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely than nonblack patients to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger than nonblack patients (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from previous studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Because our analysis adjusts for traditional variables associated with racial disparities in health care, further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

The researchers said that they had no financial conflicts to disclose.

Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis compared with nonblack patients, based on data from more than 7,000 adults published online Aug. 30 in Circulation.

To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008.

The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).

For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.

The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1 year, 2 years, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.

In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.

“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.

Black patients were more likely than nonblack patients to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.

In a univariate analysis, black patients were significantly more likely than nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger than nonblack patients (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.

The results support data from previous studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.

“Because our analysis adjusts for traditional variables associated with racial disparities in health care, further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.

The researchers said that they had no financial conflicts to disclose.

The pandemic caused by the 2009 H1N1 influenza virus is over, according to a statement issued Aug. 10 by Dr. Margaret Chan, director-general of the World Health Organization.

The Emergency Committee of the WHO declared the end of the H1N1 pandemic after reviewing the most recent global influenza data, including reports from countries that are now in the midst of flu season.

The H1N1 virus has not gone away, but the absence of out-of-season flu outbreaks and the current disease intensity levels have changed significantly from a year ago and now resemble seasonal influenza, Dr. Chan said in her statement. Many countries are reporting a mix of flu viruses, compared with the domination of the 2009 H1N1 virus at this time last year, she said.

“Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period,” Dr. Chan said.

The 2010-2011 flu vaccine has been formulated to protect against the 2009 H1N1 virus, an H3N1 virus, and an influenza B virus, according to the Centers for Disease Control and Prevention.

The pandemic caused by the 2009 H1N1 influenza virus is over, according to a statement issued Aug. 10 by Dr. Margaret Chan, director-general of the World Health Organization.

The Emergency Committee of the WHO declared the end of the H1N1 pandemic after reviewing the most recent global influenza data, including reports from countries that are now in the midst of flu season.

The H1N1 virus has not gone away, but the absence of out-of-season flu outbreaks and the current disease intensity levels have changed significantly from a year ago and now resemble seasonal influenza, Dr. Chan said in her statement. Many countries are reporting a mix of flu viruses, compared with the domination of the 2009 H1N1 virus at this time last year, she said.

“Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period,” Dr. Chan said.

The 2010-2011 flu vaccine has been formulated to protect against the 2009 H1N1 virus, an H3N1 virus, and an influenza B virus, according to the Centers for Disease Control and Prevention.

The pandemic caused by the 2009 H1N1 influenza virus is over, according to a statement issued Aug. 10 by Dr. Margaret Chan, director-general of the World Health Organization.

The Emergency Committee of the WHO declared the end of the H1N1 pandemic after reviewing the most recent global influenza data, including reports from countries that are now in the midst of flu season.

The H1N1 virus has not gone away, but the absence of out-of-season flu outbreaks and the current disease intensity levels have changed significantly from a year ago and now resemble seasonal influenza, Dr. Chan said in her statement. Many countries are reporting a mix of flu viruses, compared with the domination of the 2009 H1N1 virus at this time last year, she said.

“Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period,” Dr. Chan said.

The 2010-2011 flu vaccine has been formulated to protect against the 2009 H1N1 virus, an H3N1 virus, and an influenza B virus, according to the Centers for Disease Control and Prevention.

Combination topical tretinoin and clindamycin was as effective as combination salicylic acid and clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.

The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology.

Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eyll University in Izmir, Turkey, and colleagues.

Researchers randomized 46 acne patients aged 18-31 years to one of the two combination therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).

After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).

After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.

All reported side effects were mild to moderate, and most occurred during the first 2 weeks of treatment. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).

Although the efficacy of the all-TRA/CDP was higher in the first 2 weeks, the end results were similar, suggesting SA/CDP can be an effective alternative to all-TRA/CDP, the researchers found. The results support data from previous studies, and they suggest that CDP can help reduce the irritation associated with all-TRA.

The researchers had no financial conflicts to disclose.

Combination topical tretinoin and clindamycin was as effective as combination salicylic acid and clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.

The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology.

Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eyll University in Izmir, Turkey, and colleagues.

Researchers randomized 46 acne patients aged 18-31 years to one of the two combination therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).

After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).

After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.

All reported side effects were mild to moderate, and most occurred during the first 2 weeks of treatment. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).

Although the efficacy of the all-TRA/CDP was higher in the first 2 weeks, the end results were similar, suggesting SA/CDP can be an effective alternative to all-TRA/CDP, the researchers found. The results support data from previous studies, and they suggest that CDP can help reduce the irritation associated with all-TRA.

The researchers had no financial conflicts to disclose.

Combination topical tretinoin and clindamycin was as effective as combination salicylic acid and clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.

The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology.

Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eyll University in Izmir, Turkey, and colleagues.

Researchers randomized 46 acne patients aged 18-31 years to one of the two combination therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).

After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).

After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.

All reported side effects were mild to moderate, and most occurred during the first 2 weeks of treatment. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).

Although the efficacy of the all-TRA/CDP was higher in the first 2 weeks, the end results were similar, suggesting SA/CDP can be an effective alternative to all-TRA/CDP, the researchers found. The results support data from previous studies, and they suggest that CDP can help reduce the irritation associated with all-TRA.

The researchers had no financial conflicts to disclose.

CRYSTAL CITY, Va. – Aliskiren in combination with either hydrochlorothiazide or amlodipine reduced central systolic blood pressure significantly more than did amlodipine alone in an African American population, based on data from two studies of several hundred adults.

Previous studies have suggested that cardiovascular morbidity might be more closely linked to central blood pressure than to systolic blood pressure, according to Dr. Keith Ferdinand of Emory University in Atlanta, and colleagues. Additional studies have shown that central blood pressure tends to be higher in healthy young black men, compared with healthy young white men, the researchers noted.

To compare the effects of a combination aliskiren/hydrochlorothiazide (HCTZ) in blacks with stage II hypertension, the researchers reviewed a subset of patients from two safety and efficacy studies of aliskiren/HCTZ.

Overall, central systolic blood pressure was reduced by approximately 30 mm Hg from baseline in each study, the researchers said, which suggests that aliskiren combined with either a diuretic or calcium channel blocker might be equally effective in African American patients.

The study findings were presented in a poster at the annual meeting of the International Society on Hypertension in Blacks.

In study 1, which included 53 sites throughout the United States, 166 patients were randomized to 300 mg aliskiren/25 mg HCTZ, and 166 received 10 mg amlodipine.

In study 2, a total of 220 adults were randomized to receive 300 mg aliskiren/10 mg amlodipine, and 223 received 10 mg amlodipine.

In study 1, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/HCTZ group, compared with the amlodipine-only group (30.1 mm Hg and 21.2 mm Hg, respectively) after 8 weeks of treatment. Changes in the peripheral measure of systolic blood pressure were not significant in either group.

In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively). But in this study, the mean reduction in the peripheral measure of systolic blood pressure also was significant (34.1 mm Hg and 28.9 mm Hg, respectively).

Aliskiren-based combination therapy also reduced diastolic blood pressure in both studies, but the mean reductions only reached significance in study 2. In study 2, the mean reductions in the central measure of diastolic blood pressure in the aliskiren/amlodipine group and the amlodipine-only group were 16.0 mm Hg vs. 9.9 mm Hg, respectively, and the mean reductions in the peripheral measure of diastolic blood pressure for the two groups were 14.3 mm Hg and 10.5 mm Hg, respectively.

The average age of the patients was 53 years, and approximately half were women. Patients with type 1 diabetes or type 2 diabetes who took insulin were excluded, as were patients with a history of heart failure, myocardial infarction, or other heart problems within a year of the study.

Reports of adverse events were similar between the two groups in each study, and the most common adverse events included headache, diarrhea, nausea, hypokalemia, nasopharyngitis, upper respiratory tract infection, peripheral edema, and pain.

The study was sponsored by Novartis Pharmaceuticals Corp. Dr. Ferdinand had no financial conflicts to disclose, but one of the study co-authors is an employee of Novartis Pharmaceuticals.

CRYSTAL CITY, Va. – Aliskiren in combination with either hydrochlorothiazide or amlodipine reduced central systolic blood pressure significantly more than did amlodipine alone in an African American population, based on data from two studies of several hundred adults.

Previous studies have suggested that cardiovascular morbidity might be more closely linked to central blood pressure than to systolic blood pressure, according to Dr. Keith Ferdinand of Emory University in Atlanta, and colleagues. Additional studies have shown that central blood pressure tends to be higher in healthy young black men, compared with healthy young white men, the researchers noted.

To compare the effects of a combination aliskiren/hydrochlorothiazide (HCTZ) in blacks with stage II hypertension, the researchers reviewed a subset of patients from two safety and efficacy studies of aliskiren/HCTZ.

Overall, central systolic blood pressure was reduced by approximately 30 mm Hg from baseline in each study, the researchers said, which suggests that aliskiren combined with either a diuretic or calcium channel blocker might be equally effective in African American patients.

The study findings were presented in a poster at the annual meeting of the International Society on Hypertension in Blacks.

In study 1, which included 53 sites throughout the United States, 166 patients were randomized to 300 mg aliskiren/25 mg HCTZ, and 166 received 10 mg amlodipine.

In study 2, a total of 220 adults were randomized to receive 300 mg aliskiren/10 mg amlodipine, and 223 received 10 mg amlodipine.

In study 1, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/HCTZ group, compared with the amlodipine-only group (30.1 mm Hg and 21.2 mm Hg, respectively) after 8 weeks of treatment. Changes in the peripheral measure of systolic blood pressure were not significant in either group.

In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively). But in this study, the mean reduction in the peripheral measure of systolic blood pressure also was significant (34.1 mm Hg and 28.9 mm Hg, respectively).

Aliskiren-based combination therapy also reduced diastolic blood pressure in both studies, but the mean reductions only reached significance in study 2. In study 2, the mean reductions in the central measure of diastolic blood pressure in the aliskiren/amlodipine group and the amlodipine-only group were 16.0 mm Hg vs. 9.9 mm Hg, respectively, and the mean reductions in the peripheral measure of diastolic blood pressure for the two groups were 14.3 mm Hg and 10.5 mm Hg, respectively.

The average age of the patients was 53 years, and approximately half were women. Patients with type 1 diabetes or type 2 diabetes who took insulin were excluded, as were patients with a history of heart failure, myocardial infarction, or other heart problems within a year of the study.

Reports of adverse events were similar between the two groups in each study, and the most common adverse events included headache, diarrhea, nausea, hypokalemia, nasopharyngitis, upper respiratory tract infection, peripheral edema, and pain.

The study was sponsored by Novartis Pharmaceuticals Corp. Dr. Ferdinand had no financial conflicts to disclose, but one of the study co-authors is an employee of Novartis Pharmaceuticals.

CRYSTAL CITY, Va. – Aliskiren in combination with either hydrochlorothiazide or amlodipine reduced central systolic blood pressure significantly more than did amlodipine alone in an African American population, based on data from two studies of several hundred adults.

Previous studies have suggested that cardiovascular morbidity might be more closely linked to central blood pressure than to systolic blood pressure, according to Dr. Keith Ferdinand of Emory University in Atlanta, and colleagues. Additional studies have shown that central blood pressure tends to be higher in healthy young black men, compared with healthy young white men, the researchers noted.

To compare the effects of a combination aliskiren/hydrochlorothiazide (HCTZ) in blacks with stage II hypertension, the researchers reviewed a subset of patients from two safety and efficacy studies of aliskiren/HCTZ.

Overall, central systolic blood pressure was reduced by approximately 30 mm Hg from baseline in each study, the researchers said, which suggests that aliskiren combined with either a diuretic or calcium channel blocker might be equally effective in African American patients.

The study findings were presented in a poster at the annual meeting of the International Society on Hypertension in Blacks.

In study 1, which included 53 sites throughout the United States, 166 patients were randomized to 300 mg aliskiren/25 mg HCTZ, and 166 received 10 mg amlodipine.

In study 2, a total of 220 adults were randomized to receive 300 mg aliskiren/10 mg amlodipine, and 223 received 10 mg amlodipine.

In study 1, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/HCTZ group, compared with the amlodipine-only group (30.1 mm Hg and 21.2 mm Hg, respectively) after 8 weeks of treatment. Changes in the peripheral measure of systolic blood pressure were not significant in either group.

In study 2, the mean reduction in the central measure of systolic blood pressure was significantly greater in the aliskiren/amlodipine group, compared with the amlodipine-only group after 8 weeks of treatment (29.8 mm Hg and 24.2 mm Hg, respectively). But in this study, the mean reduction in the peripheral measure of systolic blood pressure also was significant (34.1 mm Hg and 28.9 mm Hg, respectively).

Aliskiren-based combination therapy also reduced diastolic blood pressure in both studies, but the mean reductions only reached significance in study 2. In study 2, the mean reductions in the central measure of diastolic blood pressure in the aliskiren/amlodipine group and the amlodipine-only group were 16.0 mm Hg vs. 9.9 mm Hg, respectively, and the mean reductions in the peripheral measure of diastolic blood pressure for the two groups were 14.3 mm Hg and 10.5 mm Hg, respectively.

The average age of the patients was 53 years, and approximately half were women. Patients with type 1 diabetes or type 2 diabetes who took insulin were excluded, as were patients with a history of heart failure, myocardial infarction, or other heart problems within a year of the study.

Reports of adverse events were similar between the two groups in each study, and the most common adverse events included headache, diarrhea, nausea, hypokalemia, nasopharyngitis, upper respiratory tract infection, peripheral edema, and pain.

The study was sponsored by Novartis Pharmaceuticals Corp. Dr. Ferdinand had no financial conflicts to disclose, but one of the study co-authors is an employee of Novartis Pharmaceuticals.