Heidi Splete

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.

Single treatment with a carbon dioxide fractional laser was as effective for acne scars as a nonablative fractional system, according to results of a randomized split-face study.

Fractional lasers are well tolerated and widely used to treat scarring, but patients often need multiple sessions to achieve clinical improvement, reported Dr. S.B. Cho of Yonsei University College of Medicine in Seoul, Korea, and colleagues.

However, previous studies have shown that carbon dioxide fractional laser systems can improve scars in as few as three treatments.

In this study, the researchers directly compared improvements in acne scarring after half of a patient’s face underwent a single treatment with a nonablative 1550-nm erbium-doped fractional photothermolysis system (FPS) and the other half underwent a single treatment with an ablative 10,600-nm carbon dioxide fractional laser system (CO₂ FS).

The eight patients in the study were Asian males (Fitzpatrick skin type IV) aged 20 to 23 years with mild to severe atrophic acne scars.

At follow-up 3 months after FPS treatment, six of the eight patients showed clinical improvements of 26%-50% from baseline, one patient showed a clinical improvement of 51%-75%, and one showed no clinical improvement (J. Eur. Acad. Dermatol. Venereol. 2010;24:921-5). As for CO₂ FS results at 3 months, five of the eight patients had a 26%-50% clinical improvement from baseline, two patients had a 51%-75% improvement, and one had an improvement of over 76%.

The level of clinical improvement was not affected by the type of acne scar (boxcar, icepick, or rolling).

The average VAS pain score on a scale of 0, no pain, to 10, severe pain, was significantly higher after the CO₂ FS treatment, compared with the FPS treatment (7.0 vs. 3.9, respectively). However, patient-reported satisfaction was higher after the CO₂ FS treatment. Two patients (25%) were “very satisfied,” four (50%) were “satisfied,” one (12.5%) was “slightly satisfied,” and one (12.5%) was “unsatisfied.” After the FPS treatment, none of the patients were very satisfied, two (25%) were satisfied, five (62.5%) were slightly satisfied, and one (12.5%) was unsatisfied.

Common side effects associated with both treatments included crusting, scaling, and erythema. The average duration of crusting or scaling was significantly longer in the CO₂ FS group, compared with the FPS group (7.4 days vs. 2.3 days, respectively). However, the difference in post-therapy erythema was not significantly different between the two groups (11.5 days vs. 7.5 days, respectively).

“We could not completely eliminate the possibility of subject bias as the participants experienced different posttreatment responses with FPS and CO₂ FS,” the researchers wrote. But the results suggest that a single treatment with CO₂ FS might be more effective than a single treatment with FPS.

Although the findings are not conclusive, given the study’s small size, they could serve as a reference for clinicians choosing among laser options for acne scar treatment, the researchers added.

Dr. Cho and colleagues had no financial conflicts to disclose.

Single treatment with a carbon dioxide fractional laser was as effective for acne scars as a nonablative fractional system, according to results of a randomized split-face study.

Fractional lasers are well tolerated and widely used to treat scarring, but patients often need multiple sessions to achieve clinical improvement, reported Dr. S.B. Cho of Yonsei University College of Medicine in Seoul, Korea, and colleagues.

However, previous studies have shown that carbon dioxide fractional laser systems can improve scars in as few as three treatments.

In this study, the researchers directly compared improvements in acne scarring after half of a patient’s face underwent a single treatment with a nonablative 1550-nm erbium-doped fractional photothermolysis system (FPS) and the other half underwent a single treatment with an ablative 10,600-nm carbon dioxide fractional laser system (CO₂ FS).

The eight patients in the study were Asian males (Fitzpatrick skin type IV) aged 20 to 23 years with mild to severe atrophic acne scars.

At follow-up 3 months after FPS treatment, six of the eight patients showed clinical improvements of 26%-50% from baseline, one patient showed a clinical improvement of 51%-75%, and one showed no clinical improvement (J. Eur. Acad. Dermatol. Venereol. 2010;24:921-5). As for CO₂ FS results at 3 months, five of the eight patients had a 26%-50% clinical improvement from baseline, two patients had a 51%-75% improvement, and one had an improvement of over 76%.

The level of clinical improvement was not affected by the type of acne scar (boxcar, icepick, or rolling).

The average VAS pain score on a scale of 0, no pain, to 10, severe pain, was significantly higher after the CO₂ FS treatment, compared with the FPS treatment (7.0 vs. 3.9, respectively). However, patient-reported satisfaction was higher after the CO₂ FS treatment. Two patients (25%) were “very satisfied,” four (50%) were “satisfied,” one (12.5%) was “slightly satisfied,” and one (12.5%) was “unsatisfied.” After the FPS treatment, none of the patients were very satisfied, two (25%) were satisfied, five (62.5%) were slightly satisfied, and one (12.5%) was unsatisfied.

Common side effects associated with both treatments included crusting, scaling, and erythema. The average duration of crusting or scaling was significantly longer in the CO₂ FS group, compared with the FPS group (7.4 days vs. 2.3 days, respectively). However, the difference in post-therapy erythema was not significantly different between the two groups (11.5 days vs. 7.5 days, respectively).

“We could not completely eliminate the possibility of subject bias as the participants experienced different posttreatment responses with FPS and CO₂ FS,” the researchers wrote. But the results suggest that a single treatment with CO₂ FS might be more effective than a single treatment with FPS.

Although the findings are not conclusive, given the study’s small size, they could serve as a reference for clinicians choosing among laser options for acne scar treatment, the researchers added.

Dr. Cho and colleagues had no financial conflicts to disclose.

Single treatment with a carbon dioxide fractional laser was as effective for acne scars as a nonablative fractional system, according to results of a randomized split-face study.

Fractional lasers are well tolerated and widely used to treat scarring, but patients often need multiple sessions to achieve clinical improvement, reported Dr. S.B. Cho of Yonsei University College of Medicine in Seoul, Korea, and colleagues.

However, previous studies have shown that carbon dioxide fractional laser systems can improve scars in as few as three treatments.

In this study, the researchers directly compared improvements in acne scarring after half of a patient’s face underwent a single treatment with a nonablative 1550-nm erbium-doped fractional photothermolysis system (FPS) and the other half underwent a single treatment with an ablative 10,600-nm carbon dioxide fractional laser system (CO₂ FS).

The eight patients in the study were Asian males (Fitzpatrick skin type IV) aged 20 to 23 years with mild to severe atrophic acne scars.

At follow-up 3 months after FPS treatment, six of the eight patients showed clinical improvements of 26%-50% from baseline, one patient showed a clinical improvement of 51%-75%, and one showed no clinical improvement (J. Eur. Acad. Dermatol. Venereol. 2010;24:921-5). As for CO₂ FS results at 3 months, five of the eight patients had a 26%-50% clinical improvement from baseline, two patients had a 51%-75% improvement, and one had an improvement of over 76%.

The level of clinical improvement was not affected by the type of acne scar (boxcar, icepick, or rolling).

The average VAS pain score on a scale of 0, no pain, to 10, severe pain, was significantly higher after the CO₂ FS treatment, compared with the FPS treatment (7.0 vs. 3.9, respectively). However, patient-reported satisfaction was higher after the CO₂ FS treatment. Two patients (25%) were “very satisfied,” four (50%) were “satisfied,” one (12.5%) was “slightly satisfied,” and one (12.5%) was “unsatisfied.” After the FPS treatment, none of the patients were very satisfied, two (25%) were satisfied, five (62.5%) were slightly satisfied, and one (12.5%) was unsatisfied.

Common side effects associated with both treatments included crusting, scaling, and erythema. The average duration of crusting or scaling was significantly longer in the CO₂ FS group, compared with the FPS group (7.4 days vs. 2.3 days, respectively). However, the difference in post-therapy erythema was not significantly different between the two groups (11.5 days vs. 7.5 days, respectively).

“We could not completely eliminate the possibility of subject bias as the participants experienced different posttreatment responses with FPS and CO₂ FS,” the researchers wrote. But the results suggest that a single treatment with CO₂ FS might be more effective than a single treatment with FPS.

Although the findings are not conclusive, given the study’s small size, they could serve as a reference for clinicians choosing among laser options for acne scar treatment, the researchers added.

Dr. Cho and colleagues had no financial conflicts to disclose.

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. The findings were published online Aug. 4 in the journal Circulation.

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 (CVD) 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. Based on 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 of the study group was 61 years, and 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 m2) was identified in 415 individuals (28%) after the exclusion of 112 individuals with prevalent cardiovascular disease.

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 CVD 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.

In an accompanying editorial, Dr. Clinton B. Wright and Dr. Ralph L. Sacco of the department of neurology at the University of Miami noted that the cross-sectional nature of the study prevented the identification of a causal relationship, which means that brain volume differences might be due to normal aging or other underlying processes that could contribute to dementia. However, they pointed out that the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]).

None of the investigators or editorialists 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. The findings were published online Aug. 4 in the journal Circulation.

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 (CVD) 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. Based on 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 of the study group was 61 years, and 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 m2) was identified in 415 individuals (28%) after the exclusion of 112 individuals with prevalent cardiovascular disease.

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 CVD 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.

In an accompanying editorial, Dr. Clinton B. Wright and Dr. Ralph L. Sacco of the department of neurology at the University of Miami noted that the cross-sectional nature of the study prevented the identification of a causal relationship, which means that brain volume differences might be due to normal aging or other underlying processes that could contribute to dementia. However, they pointed out that the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]).

None of the investigators or editorialists 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. The findings were published online Aug. 4 in the journal Circulation.

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 (CVD) 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. Based on 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 of the study group was 61 years, and 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 m2) was identified in 415 individuals (28%) after the exclusion of 112 individuals with prevalent cardiovascular disease.

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 CVD 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.

In an accompanying editorial, Dr. Clinton B. Wright and Dr. Ralph L. Sacco of the department of neurology at the University of Miami noted that the cross-sectional nature of the study prevented the identification of a causal relationship, which means that brain volume differences might be due to normal aging or other underlying processes that could contribute to dementia. However, they pointed out that the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]).

None of the investigators or editorialists 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.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from 2,492 patients in TRINITY, a randomized, phase III, parallel-group study conducted at 317 U.S. and Puerto Rico clinical sites.

The primary measure of effectiveness was a significant reduction in seated diastolic BP after 12 weeks of daily treatment; the secondary measure was a significant reduction in systolic BP over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic BP compared with baseline measures. But the triple-drug combination reduced seated diastolic BP by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic BP in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target BP goal of less than 140/90 mm Hg were able to reach their goal on the triple-combination regimen, as were 23% of blacks and 29% of nonblacks with a target BP goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. About 15% of the study population had controlled diabetes, and about 63% were obese.

The incidence of adverse events was similar in all four treatment groups. Adverse events that emerged during treatment in at least 3% of any group included dizziness, headache, peripheral edema, fatigue, and nausea.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and been a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

Editor's note: At press time, Daiichi Sankyo announced that the drug combination had received Food and Drug Administration approval for the treatment of uncontrolled hypertension, and that it would be marketed as Tribenzor.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from 2,492 patients in TRINITY, a randomized, phase III, parallel-group study conducted at 317 U.S. and Puerto Rico clinical sites.

The primary measure of effectiveness was a significant reduction in seated diastolic BP after 12 weeks of daily treatment; the secondary measure was a significant reduction in systolic BP over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic BP compared with baseline measures. But the triple-drug combination reduced seated diastolic BP by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic BP in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target BP goal of less than 140/90 mm Hg were able to reach their goal on the triple-combination regimen, as were 23% of blacks and 29% of nonblacks with a target BP goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. About 15% of the study population had controlled diabetes, and about 63% were obese.

The incidence of adverse events was similar in all four treatment groups. Adverse events that emerged during treatment in at least 3% of any group included dizziness, headache, peripheral edema, fatigue, and nausea.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and been a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

Editor's note: At press time, Daiichi Sankyo announced that the drug combination had received Food and Drug Administration approval for the treatment of uncontrolled hypertension, and that it would be marketed as Tribenzor.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from 2,492 patients in TRINITY, a randomized, phase III, parallel-group study conducted at 317 U.S. and Puerto Rico clinical sites.

The primary measure of effectiveness was a significant reduction in seated diastolic BP after 12 weeks of daily treatment; the secondary measure was a significant reduction in systolic BP over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic BP compared with baseline measures. But the triple-drug combination reduced seated diastolic BP by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic BP in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target BP goal of less than 140/90 mm Hg were able to reach their goal on the triple-combination regimen, as were 23% of blacks and 29% of nonblacks with a target BP goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. About 15% of the study population had controlled diabetes, and about 63% were obese.

The incidence of adverse events was similar in all four treatment groups. Adverse events that emerged during treatment in at least 3% of any group included dizziness, headache, peripheral edema, fatigue, and nausea.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and been a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

Editor's note: At press time, Daiichi Sankyo announced that the drug combination had received Food and Drug Administration approval for the treatment of uncontrolled hypertension, and that it would be marketed as Tribenzor.

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. The findings were published online.

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 (CVD) 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. Based on 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 of the study group was 61 years, and 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 CVD 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.

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. The findings were published online.

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 (CVD) 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. Based on 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 of the study group was 61 years, and 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 CVD 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.

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. The findings were published online.

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 (CVD) 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. Based on 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 of the study group was 61 years, and 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 CVD 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.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on data from 2,492 patients in an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from patients in TRINITY, a randomized, phase III parallel-group study conducted at 317 clinical sites in the United States and Puerto Rico.

The primary measure of effectiveness was a significant reduction in seated diastolic blood pressure after 12 weeks of daily treatment, and the secondary measure was a significant reduction in systolic blood pressure over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic blood pressure compared with baseline measures, but the triple-drug combination reduced seated diastolic blood pressure by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in each of the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic blood pressure in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target blood pressure goal of less than 140/90 mm Hg were able to reach their goal on the triple-combination regimen, as were 23% of blacks and 29% of nonblacks with a target blood pressure goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. Approximately 15% of the study population had controlled diabetes, and about 63% were obese.

The results suggest that the triple-drug therapy is equally effective for controlling high blood pressure in patients of different ethnic groups, the researchers noted.

The drug, marketed as Tribenzor, was approved by the Food and Drug Administration last month. One other triple-combination antihypertensive drug that includes amlodipine, valsartan, and HCTZ (Exforge HCT) was approved in 2009.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on data from 2,492 patients in an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from patients in TRINITY, a randomized, phase III parallel-group study conducted at 317 clinical sites in the United States and Puerto Rico.

The primary measure of effectiveness was a significant reduction in seated diastolic blood pressure after 12 weeks of daily treatment, and the secondary measure was a significant reduction in systolic blood pressure over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic blood pressure compared with baseline measures, but the triple-drug combination reduced seated diastolic blood pressure by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in each of the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic blood pressure in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target blood pressure goal of less than 140/90 mm Hg were able to reach their goal on the triple-combination regimen, as were 23% of blacks and 29% of nonblacks with a target blood pressure goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. Approximately 15% of the study population had controlled diabetes, and about 63% were obese.

The results suggest that the triple-drug therapy is equally effective for controlling high blood pressure in patients of different ethnic groups, the researchers noted.

The drug, marketed as Tribenzor, was approved by the Food and Drug Administration last month. One other triple-combination antihypertensive drug that includes amlodipine, valsartan, and HCTZ (Exforge HCT) was approved in 2009.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on data from 2,492 patients in an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from patients in TRINITY, a randomized, phase III parallel-group study conducted at 317 clinical sites in the United States and Puerto Rico.

The primary measure of effectiveness was a significant reduction in seated diastolic blood pressure after 12 weeks of daily treatment, and the secondary measure was a significant reduction in systolic blood pressure over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic blood pressure compared with baseline measures, but the triple-drug combination reduced seated diastolic blood pressure by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in each of the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic blood pressure in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target blood pressure goal of less than 140/90 mm Hg were able to reach their goal on the triple-combination regimen, as were 23% of blacks and 29% of nonblacks with a target blood pressure goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. Approximately 15% of the study population had controlled diabetes, and about 63% were obese.

The results suggest that the triple-drug therapy is equally effective for controlling high blood pressure in patients of different ethnic groups, the researchers noted.

The drug, marketed as Tribenzor, was approved by the Food and Drug Administration last month. One other triple-combination antihypertensive drug that includes amlodipine, valsartan, and HCTZ (Exforge HCT) was approved in 2009.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on data from 2,492 patients in an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from patients in TRINITY, a randomized, phase III parallel-group study conducted at 317 clinical sites in the United States and Puerto Rico.

The primary measure of effectiveness was a significant reduction in seated diastolic blood pressure after 12 weeks of daily treatment, and the secondary measure was a significant reduction in systolic blood pressure over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic blood pressure compared with baseline measures. But the triple-drug combination reduced seated diastolic blood pressure by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in each of the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic blood pressure in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target blood pressure goal of less than 140/90 mm Hg reached their goal on the triple-combination regimen, asw23% of blacks and 29% of nonblacks with a target blood pressure goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. Approximately 15% of the study population had controlled diabetes, and about 63% were obese.

The incidence of all adverse events and severe adverse events was similar among all four treatment groups. Adverse events that occurred in at least 3% of any group included dizziness, headache, peripheral edema, fatigue, and nausea.

The drug, marketed as Tribenzor, was approved by the Food and Drug Administration last month. One other triple-combination antihypertensive drug that includes amlodipine, valsartan, and HCTZ (Exforge HCT) was approved by the FDA in 2009.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on data from 2,492 patients in an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from patients in TRINITY, a randomized, phase III parallel-group study conducted at 317 clinical sites in the United States and Puerto Rico.

The primary measure of effectiveness was a significant reduction in seated diastolic blood pressure after 12 weeks of daily treatment, and the secondary measure was a significant reduction in systolic blood pressure over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic blood pressure compared with baseline measures. But the triple-drug combination reduced seated diastolic blood pressure by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in each of the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic blood pressure in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target blood pressure goal of less than 140/90 mm Hg reached their goal on the triple-combination regimen, asw23% of blacks and 29% of nonblacks with a target blood pressure goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. Approximately 15% of the study population had controlled diabetes, and about 63% were obese.

The incidence of all adverse events and severe adverse events was similar among all four treatment groups. Adverse events that occurred in at least 3% of any group included dizziness, headache, peripheral edema, fatigue, and nausea.

The drug, marketed as Tribenzor, was approved by the Food and Drug Administration last month. One other triple-combination antihypertensive drug that includes amlodipine, valsartan, and HCTZ (Exforge HCT) was approved by the FDA in 2009.

Major Finding: After 12 weeks, 66% of blacks and 72% of nonblacks reached a target BP goal of less than 140/90 mm Hg and 23% of blacks and 29% of nonblacks reached a target of less than 120/80 mm Hg by taking a pill combining three different medications, compared with those who took dual-combination therapies for 12 weeks.

Data Source: A phase III, randomized, parallel-group study of 2,492 adults with moderate to severe hypertension.

Disclosures: The study was funded by Daiichi Sankyo Inc. Dr. Oparil has received research grants from, and served as a speaker or consultant for, multiple pharmaceutical companies, including Daiichi Sankyo.

WASHINGTON — A triple-combination pill including 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide significantly improved diastolic and systolic blood pressure in black and nonblack adults with moderate to severe hypertension, based on data from 2,492 patients in an investigational study.

Dr. Suzanne Oparil of the University of Alabama at Birmingham and her colleagues reviewed data from patients in TRINITY, a randomized, phase III parallel-group study conducted at 317 clinical sites in the United States and Puerto Rico.

The primary measure of effectiveness was a significant reduction in seated diastolic blood pressure after 12 weeks of daily treatment, and the secondary measure was a significant reduction in systolic blood pressure over the same period, Dr. Oparil said at the meeting.

Patients were randomized to receive one of four treatment protocols: 40 mg olmesartan, 10 mg amlodipine, and 25 mg hydrochlorothiazide (HCTZ); 40 mg olmesartan and 10 mg amlodipine; 40 mg olmesartan and 25 mg HCTZ; and 10 mg amlodipine and 25 mg HCTZ.

All treatment regimens yielded significant improvements in both systolic and diastolic blood pressure compared with baseline measures. But the triple-drug combination reduced seated diastolic blood pressure by an average of 20.8 mm Hg in black patients and 21.8 mm Hg in nonblack patients, which was significantly greater than the reductions in each of the three dual-therapy combinations.

The triple-drug combination also significantly reduced systolic blood pressure in blacks and nonblacks, with average reductions of 37.1 mm Hg and 38.9 mm Hg, respectively, both of which were significantly greater than the reductions in each of the three dual-therapy combinations.

In addition, 66% of blacks and 72% of nonblacks with a target blood pressure goal of less than 140/90 mm Hg reached their goal on the triple-combination regimen, asw23% of blacks and 29% of nonblacks with a target blood pressure goal of less than 120/80 mm Hg. The percentages in the triple-combination group were significantly higher than those in any of the dual-therapy groups.

The researchers excluded pregnant or lactating women and individuals with severe renal insufficiency, uncontrolled diabetes, uncontrolled hypertension, and a history of significant cardiac disease. The baseline demographics were similar across all groups, and the mean age of the patients was 54 years. Approximately 15% of the study population had controlled diabetes, and about 63% were obese.

The incidence of all adverse events and severe adverse events was similar among all four treatment groups. Adverse events that occurred in at least 3% of any group included dizziness, headache, peripheral edema, fatigue, and nausea.

The drug, marketed as Tribenzor, was approved by the Food and Drug Administration last month. One other triple-combination antihypertensive drug that includes amlodipine, valsartan, and HCTZ (Exforge HCT) was approved by the FDA in 2009.

NEW ORLEANS — High insulin levels, insulin resistance, and central body fat were each significantly associated with an increased risk of Barrett's esophagus in a case-control study presented at the meeting.

Previous studies have shown that obesity increases the risk of both esophageal adenocarcinoma and its precursor, Barrett's esophagus. In this study, Dr. Katarina Greer and her colleagues investigated whether central adiposity, hyperinsulinemia, and insulin resistance are independent risk factors for Barrett's esophagus.

“The mechanism through which obesity promotes cancer is still largely unknown,” said Dr. Greer of University Hospitals Case Medical Center in Cleveland, Ohio.

The researchers identified 135 adults with Barrett's esophagus from consecutive patients seen at a single tertiary care center. These patients were compared with two adult control groups—135 with gastroesophageal reflux disease (GERD) and 932 controls undergoing routine colonoscopies.

Overall, high levels of insulin and insulin resistance were significant independent risk factors for Barrett's esophagus, Dr. Greer noted. Persons in the highest quartile of serum insulin had a 2.8-fold increase in the risk of Barrett's esophagus, compared with those in the lowest quartile, after adjustment for age, sex, and waist-to-hip ratio.

Regarding insulin resistance, persons in the highest quartile of values for the homeostasis model assessment–insulin resistance (HOMA-IR) were about 3 times more likely to develop Barrett's esophagus than were those in the lowest quartile.

The mean fasting insulin levels were significantly higher in Barrett's esophagus patients than in colonoscopy patients. In addition, Barrett's esophagus patients were more insulin resistant than either of the control groups. The mean HOMA-IR in the Barrett's esophagus group was 2.7, compared with 1.8 in the control groups.

The average BMI was 30.8 kg/m

Disclosures: Dr. Greer had no financial conflicts of interest.

NEW ORLEANS — High insulin levels, insulin resistance, and central body fat were each significantly associated with an increased risk of Barrett's esophagus in a case-control study presented at the meeting.

Previous studies have shown that obesity increases the risk of both esophageal adenocarcinoma and its precursor, Barrett's esophagus. In this study, Dr. Katarina Greer and her colleagues investigated whether central adiposity, hyperinsulinemia, and insulin resistance are independent risk factors for Barrett's esophagus.

“The mechanism through which obesity promotes cancer is still largely unknown,” said Dr. Greer of University Hospitals Case Medical Center in Cleveland, Ohio.

The researchers identified 135 adults with Barrett's esophagus from consecutive patients seen at a single tertiary care center. These patients were compared with two adult control groups—135 with gastroesophageal reflux disease (GERD) and 932 controls undergoing routine colonoscopies.

Overall, high levels of insulin and insulin resistance were significant independent risk factors for Barrett's esophagus, Dr. Greer noted. Persons in the highest quartile of serum insulin had a 2.8-fold increase in the risk of Barrett's esophagus, compared with those in the lowest quartile, after adjustment for age, sex, and waist-to-hip ratio.

Regarding insulin resistance, persons in the highest quartile of values for the homeostasis model assessment–insulin resistance (HOMA-IR) were about 3 times more likely to develop Barrett's esophagus than were those in the lowest quartile.

The mean fasting insulin levels were significantly higher in Barrett's esophagus patients than in colonoscopy patients. In addition, Barrett's esophagus patients were more insulin resistant than either of the control groups. The mean HOMA-IR in the Barrett's esophagus group was 2.7, compared with 1.8 in the control groups.

The average BMI was 30.8 kg/m

Disclosures: Dr. Greer had no financial conflicts of interest.

NEW ORLEANS — High insulin levels, insulin resistance, and central body fat were each significantly associated with an increased risk of Barrett's esophagus in a case-control study presented at the meeting.

Previous studies have shown that obesity increases the risk of both esophageal adenocarcinoma and its precursor, Barrett's esophagus. In this study, Dr. Katarina Greer and her colleagues investigated whether central adiposity, hyperinsulinemia, and insulin resistance are independent risk factors for Barrett's esophagus.

“The mechanism through which obesity promotes cancer is still largely unknown,” said Dr. Greer of University Hospitals Case Medical Center in Cleveland, Ohio.

The researchers identified 135 adults with Barrett's esophagus from consecutive patients seen at a single tertiary care center. These patients were compared with two adult control groups—135 with gastroesophageal reflux disease (GERD) and 932 controls undergoing routine colonoscopies.

Overall, high levels of insulin and insulin resistance were significant independent risk factors for Barrett's esophagus, Dr. Greer noted. Persons in the highest quartile of serum insulin had a 2.8-fold increase in the risk of Barrett's esophagus, compared with those in the lowest quartile, after adjustment for age, sex, and waist-to-hip ratio.

Regarding insulin resistance, persons in the highest quartile of values for the homeostasis model assessment–insulin resistance (HOMA-IR) were about 3 times more likely to develop Barrett's esophagus than were those in the lowest quartile.

The mean fasting insulin levels were significantly higher in Barrett's esophagus patients than in colonoscopy patients. In addition, Barrett's esophagus patients were more insulin resistant than either of the control groups. The mean HOMA-IR in the Barrett's esophagus group was 2.7, compared with 1.8 in the control groups.

The average BMI was 30.8 kg/m

Disclosures: Dr. Greer had no financial conflicts of interest.

Major Finding: Half of healthy women taking the antiepileptic carbamazepine ovulated despite taking a low-dose oral contraceptive.

Data Source: A randomized, double-blind crossover study of 24 healthy women aged 18-35 years.

Disclosures: Dr. Davis has received personal compensation from Bayer Pharmaceuticals and Schering Plough for participating on their advisory boards.

TORONTO — A standard dose of the antiepileptic drug carbamazepine allowed ovulation and the potential for pregnancy in women using low-dose birth control pills in a small randomized, double-blind study of healthy women without epilepsy.

The key clinical implication of the findings is that women using antiepileptic drugs who wish to avoid pregnancy should take additional birth control measures, according to Dr. Anne Davis of Columbia University in New York.”

“We were very surprised to see that half of the women who took the [carbamazepine] ovulated,” placing them at an obvious increased risk for pregnancy, Dr. Davis said in an interview.

Clinicians have suspected that oral contraceptives are not fully effective in women who take antiepileptic medications, Dr. Davis and colleagues said in a poster.

But case reports of breakthrough bleeding in epileptic patients were not enough to establish a causal relationship between the antiepileptic drug carbamazepine and the loss of effectiveness from low-dose oral contraceptives, the researchers said.

In this study, the researchers randomized 24 women, aged 18-35 years, with regular menstrual cycles to receive a low-dose birth control pill containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel for 4 months. In addition, the women took either 600 mg of carbamazepine or a matching placebo daily for 2 months.

Breakthrough bleeding was more frequent in the carbamazepine group, with a median of 7 bleeding days, compared with zero bleeding days in the placebo group.

At least 3 days of breakthrough bleeding occurred in 8 of 10 carbamazepine cycles, compared with 2 of 10 placebo cycles.

In addition, progesterone levels greater than 3 ng/mL (suggestive of ovulation) occurred in five of the carbamazepine cycles, compared with one of the placebo cycles.

Three women in the carbamazepine group showed increased levels of progesterone during week 1 of a cycle, immediately after the placebo pills in the oral contraceptive pack, they said.

The differences between the groups fell short of statistical significance, in part because only 10 of the 24 women completed the entire study.

Of the women initially randomized, two in the carbamazepine group and one in the placebo group did not take the drug.

Five women in the carbamazepine group discontinued due to reversible side effects, and three women in the placebo group discontinued for reasons unrelated to the medication.

One patient in the placebo group discontinued due to an adverse event, and samples were lost for one patient in each group, leaving four carbamazepine patients and six placebo patients in the final analysis.

Despite the study's small size, the results show that the known pharmacokinetic effect of carbamazepine on contraceptive steroids has a clinically significant effect, Dr. Davis said.

“If a woman is taking carbamazepine, and she needs birth control, a low-dose pill is not going to be effective,” Dr. Davis said.

“I think the next question is to figure out what will be effective for women in that situation,” she said.

Major Finding: Half of healthy women taking the antiepileptic carbamazepine ovulated despite taking a low-dose oral contraceptive.

Data Source: A randomized, double-blind crossover study of 24 healthy women aged 18-35 years.

Disclosures: Dr. Davis has received personal compensation from Bayer Pharmaceuticals and Schering Plough for participating on their advisory boards.

TORONTO — A standard dose of the antiepileptic drug carbamazepine allowed ovulation and the potential for pregnancy in women using low-dose birth control pills in a small randomized, double-blind study of healthy women without epilepsy.

The key clinical implication of the findings is that women using antiepileptic drugs who wish to avoid pregnancy should take additional birth control measures, according to Dr. Anne Davis of Columbia University in New York.”

“We were very surprised to see that half of the women who took the [carbamazepine] ovulated,” placing them at an obvious increased risk for pregnancy, Dr. Davis said in an interview.

Clinicians have suspected that oral contraceptives are not fully effective in women who take antiepileptic medications, Dr. Davis and colleagues said in a poster.

But case reports of breakthrough bleeding in epileptic patients were not enough to establish a causal relationship between the antiepileptic drug carbamazepine and the loss of effectiveness from low-dose oral contraceptives, the researchers said.

In this study, the researchers randomized 24 women, aged 18-35 years, with regular menstrual cycles to receive a low-dose birth control pill containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel for 4 months. In addition, the women took either 600 mg of carbamazepine or a matching placebo daily for 2 months.

Breakthrough bleeding was more frequent in the carbamazepine group, with a median of 7 bleeding days, compared with zero bleeding days in the placebo group.

At least 3 days of breakthrough bleeding occurred in 8 of 10 carbamazepine cycles, compared with 2 of 10 placebo cycles.

In addition, progesterone levels greater than 3 ng/mL (suggestive of ovulation) occurred in five of the carbamazepine cycles, compared with one of the placebo cycles.

Three women in the carbamazepine group showed increased levels of progesterone during week 1 of a cycle, immediately after the placebo pills in the oral contraceptive pack, they said.

The differences between the groups fell short of statistical significance, in part because only 10 of the 24 women completed the entire study.

Of the women initially randomized, two in the carbamazepine group and one in the placebo group did not take the drug.

Five women in the carbamazepine group discontinued due to reversible side effects, and three women in the placebo group discontinued for reasons unrelated to the medication.

One patient in the placebo group discontinued due to an adverse event, and samples were lost for one patient in each group, leaving four carbamazepine patients and six placebo patients in the final analysis.

Despite the study's small size, the results show that the known pharmacokinetic effect of carbamazepine on contraceptive steroids has a clinically significant effect, Dr. Davis said.

“If a woman is taking carbamazepine, and she needs birth control, a low-dose pill is not going to be effective,” Dr. Davis said.

“I think the next question is to figure out what will be effective for women in that situation,” she said.

Major Finding: Half of healthy women taking the antiepileptic carbamazepine ovulated despite taking a low-dose oral contraceptive.

Data Source: A randomized, double-blind crossover study of 24 healthy women aged 18-35 years.

Disclosures: Dr. Davis has received personal compensation from Bayer Pharmaceuticals and Schering Plough for participating on their advisory boards.

TORONTO — A standard dose of the antiepileptic drug carbamazepine allowed ovulation and the potential for pregnancy in women using low-dose birth control pills in a small randomized, double-blind study of healthy women without epilepsy.

The key clinical implication of the findings is that women using antiepileptic drugs who wish to avoid pregnancy should take additional birth control measures, according to Dr. Anne Davis of Columbia University in New York.”

“We were very surprised to see that half of the women who took the [carbamazepine] ovulated,” placing them at an obvious increased risk for pregnancy, Dr. Davis said in an interview.

Clinicians have suspected that oral contraceptives are not fully effective in women who take antiepileptic medications, Dr. Davis and colleagues said in a poster.

But case reports of breakthrough bleeding in epileptic patients were not enough to establish a causal relationship between the antiepileptic drug carbamazepine and the loss of effectiveness from low-dose oral contraceptives, the researchers said.

In this study, the researchers randomized 24 women, aged 18-35 years, with regular menstrual cycles to receive a low-dose birth control pill containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel for 4 months. In addition, the women took either 600 mg of carbamazepine or a matching placebo daily for 2 months.

Breakthrough bleeding was more frequent in the carbamazepine group, with a median of 7 bleeding days, compared with zero bleeding days in the placebo group.

At least 3 days of breakthrough bleeding occurred in 8 of 10 carbamazepine cycles, compared with 2 of 10 placebo cycles.

In addition, progesterone levels greater than 3 ng/mL (suggestive of ovulation) occurred in five of the carbamazepine cycles, compared with one of the placebo cycles.

Three women in the carbamazepine group showed increased levels of progesterone during week 1 of a cycle, immediately after the placebo pills in the oral contraceptive pack, they said.

The differences between the groups fell short of statistical significance, in part because only 10 of the 24 women completed the entire study.

Of the women initially randomized, two in the carbamazepine group and one in the placebo group did not take the drug.

Five women in the carbamazepine group discontinued due to reversible side effects, and three women in the placebo group discontinued for reasons unrelated to the medication.

One patient in the placebo group discontinued due to an adverse event, and samples were lost for one patient in each group, leaving four carbamazepine patients and six placebo patients in the final analysis.

Despite the study's small size, the results show that the known pharmacokinetic effect of carbamazepine on contraceptive steroids has a clinically significant effect, Dr. Davis said.

“If a woman is taking carbamazepine, and she needs birth control, a low-dose pill is not going to be effective,” Dr. Davis said.

“I think the next question is to figure out what will be effective for women in that situation,” she said.

Major Finding: Women with node-negative cervical cancer who had more than 30 lymph nodes removed were 37% less likely to die, compared with those who had fewer than 10 nodes removed.

Data Source: Retrospective study of more than 5,500 women in the SEER database.

Disclosures: Dr. Shah had no financial conflicts to disclose. Dr. Gold has received grants and research support from Ikonisys Inc., and he has served on the advisory board of Hologic Inc.

SAN FRANCISCO — Extensive lymphadenectomy improves survival for node-negative cervical cancer patients, based on a review of data from more than 5,500 women with stage IA2-IIA cervical cancer.

Overall, the greatest benefit was seen in women who had more than 30 nodes removed, but this was seen only in node-negative patients, Dr. Monjri Shah reported.

“Likely this represents a removal of the micrometastases, or [means that clinicians] are identifying women and triaging them to a proper adjuvant treatment group,” she said in an interview.

Lymph node status is “the most important prognostic factor that influences treatment planning,” noted Dr. Shah of Columbia University in New York. “While the diagnostic benefit of lymphadenectomy is well established, the potential therapeutic benefit remains unknown,” she told attendees, explaining why the investigators undertook the study.

Dr. Shah and colleagues reviewed data from the National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results) database on 873 node-positive patients and 4,648 node-negative patients who were diagnosed with stage IA2-IIA cervical cancer between 1998 and 2005. The researchers created separate models for node-positive and node-negative patients.

Among the node-positive patients, 131 (15%) had 10 or fewer nodes removed, 320 (37%) had 11-20 nodes removed, 236 (27%) had 21-30 nodes removed, and 186 (21%) had more than 30 nodes removed.

Among the node-negative patients, 762 (16%) had 10 or fewer nodes removed, 1,709 (37%) had 11-20 nodes removed, 1,251 (27%) had 21-30 nodes removed, and 926 (20%) had more than 30 nodes removed.

Significant predictors for a more extensive lymphadenectomy included age older than 40 years, white race, earlier year of diagnosis (1988-1993), and stage IB-IIA disease. Factors that predicted cancer-specific survival included age younger than 40 years, white race, later year of diagnosis (2000-2005), squamous histology, small tumor size, stage IA2, and the number of lymph nodes removed.

Overall, patients who had more than 30 nodes removed were 29% less likely to die than those who had 10 or fewer nodes removed. Extensive lymphadenectomy had no significant effect on survival for women with positive nodes. But among node-negative women, those with more than 30 nodes removed were 37% less likely to die than those who had fewer than 10 nodes removed.

The morbidity of lymphadenectomy should be weighed against the possible survival advantage, Dr. Shah advised.

The results were surprising in that women with positive nodes had no survival advantage with an extensive lymphadenectomy, but those with pathologically negative nodes did, she added in an interview. “Given that this is a retrospective analysis of the SEER database, we certainly need more information regarding comorbidities and factors that may have influenced patient and physician preferences for treatment,” said Dr. Shah.

Prospective, observational studies are needed to determine whether the results are an effect of extensive lymphadenectomy, and to determine how many lymph nodes constitute an adequate lymphadenectomy, as has been done in other types of cancers, she added.

Lymph node positivity is an important predictor of survival in cervical cancer, said study discussant Dr. Michael Gold of the University of Oklahoma in Oklahoma City.

In early-stage disease, lymph node positivity is among the most common criteria for adjuvant chemoradiation, said Dr. Gold. In theory, more-thorough lymphadenectomy in early-stage patients should allow clinicians to detect more occult metastatic disease, as has been shown with other cancers, including cancers of the colon, rectum, breast, lung, skin, and endometrium. Given the potential survival advantage that is seen with more thorough lymphadenectomy, more research is needed to make evidence-based recommendations.

My Take

Provocative Findings

In an interesting retrospective evaluation of the SEER database, investigators noted superior survival within the subgroup of individuals with node-negative cervical cancer who had the largest number of lymph nodes (more than 30) removed at the time of surgery, compared with those from whom fewer than 10 nodes were removed.

These provocative findings represent another example of the age-old debate as to whether the favorable outcome results from the elimination of “micrometastatic” cancer in these individuals who undergo extensive lymph node surgery, or whether the procedure has simply more carefully defined a population with “true” lymph node-negative disease.

In other words, the surgery has led to the detection of patients with microscopic, positive cancer who are no longer included in the lymph node-negative subgroup.

If this is the correct interpretation, then the procedure is helpful as a diagnostic strategy, but the performance of the surgery itself is not the reason for the improved outcome.

Only a well-designed and well-conducted, phase III, randomized trial can appropriately address and answer this important and clinically relevant issue.

MAURIE MARKMAN, M.D., is the vice president of clinical research at the University of Texas MD Anderson Cancer Center, Houston.

Vitals

Major Finding: Women with node-negative cervical cancer who had more than 30 lymph nodes removed were 37% less likely to die, compared with those who had fewer than 10 nodes removed.

Data Source: Retrospective study of more than 5,500 women in the SEER database.

Disclosures: Dr. Shah had no financial conflicts to disclose. Dr. Gold has received grants and research support from Ikonisys Inc., and he has served on the advisory board of Hologic Inc.

SAN FRANCISCO — Extensive lymphadenectomy improves survival for node-negative cervical cancer patients, based on a review of data from more than 5,500 women with stage IA2-IIA cervical cancer.

Overall, the greatest benefit was seen in women who had more than 30 nodes removed, but this was seen only in node-negative patients, Dr. Monjri Shah reported.

“Likely this represents a removal of the micrometastases, or [means that clinicians] are identifying women and triaging them to a proper adjuvant treatment group,” she said in an interview.

Lymph node status is “the most important prognostic factor that influences treatment planning,” noted Dr. Shah of Columbia University in New York. “While the diagnostic benefit of lymphadenectomy is well established, the potential therapeutic benefit remains unknown,” she told attendees, explaining why the investigators undertook the study.

Dr. Shah and colleagues reviewed data from the National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results) database on 873 node-positive patients and 4,648 node-negative patients who were diagnosed with stage IA2-IIA cervical cancer between 1998 and 2005. The researchers created separate models for node-positive and node-negative patients.

Among the node-positive patients, 131 (15%) had 10 or fewer nodes removed, 320 (37%) had 11-20 nodes removed, 236 (27%) had 21-30 nodes removed, and 186 (21%) had more than 30 nodes removed.

Among the node-negative patients, 762 (16%) had 10 or fewer nodes removed, 1,709 (37%) had 11-20 nodes removed, 1,251 (27%) had 21-30 nodes removed, and 926 (20%) had more than 30 nodes removed.

Significant predictors for a more extensive lymphadenectomy included age older than 40 years, white race, earlier year of diagnosis (1988-1993), and stage IB-IIA disease. Factors that predicted cancer-specific survival included age younger than 40 years, white race, later year of diagnosis (2000-2005), squamous histology, small tumor size, stage IA2, and the number of lymph nodes removed.

Overall, patients who had more than 30 nodes removed were 29% less likely to die than those who had 10 or fewer nodes removed. Extensive lymphadenectomy had no significant effect on survival for women with positive nodes. But among node-negative women, those with more than 30 nodes removed were 37% less likely to die than those who had fewer than 10 nodes removed.

The morbidity of lymphadenectomy should be weighed against the possible survival advantage, Dr. Shah advised.

The results were surprising in that women with positive nodes had no survival advantage with an extensive lymphadenectomy, but those with pathologically negative nodes did, she added in an interview. “Given that this is a retrospective analysis of the SEER database, we certainly need more information regarding comorbidities and factors that may have influenced patient and physician preferences for treatment,” said Dr. Shah.

Prospective, observational studies are needed to determine whether the results are an effect of extensive lymphadenectomy, and to determine how many lymph nodes constitute an adequate lymphadenectomy, as has been done in other types of cancers, she added.

Lymph node positivity is an important predictor of survival in cervical cancer, said study discussant Dr. Michael Gold of the University of Oklahoma in Oklahoma City.

In early-stage disease, lymph node positivity is among the most common criteria for adjuvant chemoradiation, said Dr. Gold. In theory, more-thorough lymphadenectomy in early-stage patients should allow clinicians to detect more occult metastatic disease, as has been shown with other cancers, including cancers of the colon, rectum, breast, lung, skin, and endometrium. Given the potential survival advantage that is seen with more thorough lymphadenectomy, more research is needed to make evidence-based recommendations.

My Take

Provocative Findings

In an interesting retrospective evaluation of the SEER database, investigators noted superior survival within the subgroup of individuals with node-negative cervical cancer who had the largest number of lymph nodes (more than 30) removed at the time of surgery, compared with those from whom fewer than 10 nodes were removed.

These provocative findings represent another example of the age-old debate as to whether the favorable outcome results from the elimination of “micrometastatic” cancer in these individuals who undergo extensive lymph node surgery, or whether the procedure has simply more carefully defined a population with “true” lymph node-negative disease.

In other words, the surgery has led to the detection of patients with microscopic, positive cancer who are no longer included in the lymph node-negative subgroup.

If this is the correct interpretation, then the procedure is helpful as a diagnostic strategy, but the performance of the surgery itself is not the reason for the improved outcome.

Only a well-designed and well-conducted, phase III, randomized trial can appropriately address and answer this important and clinically relevant issue.

MAURIE MARKMAN, M.D., is the vice president of clinical research at the University of Texas MD Anderson Cancer Center, Houston.

Vitals

Major Finding: Women with node-negative cervical cancer who had more than 30 lymph nodes removed were 37% less likely to die, compared with those who had fewer than 10 nodes removed.

Data Source: Retrospective study of more than 5,500 women in the SEER database.

Disclosures: Dr. Shah had no financial conflicts to disclose. Dr. Gold has received grants and research support from Ikonisys Inc., and he has served on the advisory board of Hologic Inc.

SAN FRANCISCO — Extensive lymphadenectomy improves survival for node-negative cervical cancer patients, based on a review of data from more than 5,500 women with stage IA2-IIA cervical cancer.

Overall, the greatest benefit was seen in women who had more than 30 nodes removed, but this was seen only in node-negative patients, Dr. Monjri Shah reported.

“Likely this represents a removal of the micrometastases, or [means that clinicians] are identifying women and triaging them to a proper adjuvant treatment group,” she said in an interview.

Lymph node status is “the most important prognostic factor that influences treatment planning,” noted Dr. Shah of Columbia University in New York. “While the diagnostic benefit of lymphadenectomy is well established, the potential therapeutic benefit remains unknown,” she told attendees, explaining why the investigators undertook the study.

Dr. Shah and colleagues reviewed data from the National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results) database on 873 node-positive patients and 4,648 node-negative patients who were diagnosed with stage IA2-IIA cervical cancer between 1998 and 2005. The researchers created separate models for node-positive and node-negative patients.

Among the node-positive patients, 131 (15%) had 10 or fewer nodes removed, 320 (37%) had 11-20 nodes removed, 236 (27%) had 21-30 nodes removed, and 186 (21%) had more than 30 nodes removed.

Among the node-negative patients, 762 (16%) had 10 or fewer nodes removed, 1,709 (37%) had 11-20 nodes removed, 1,251 (27%) had 21-30 nodes removed, and 926 (20%) had more than 30 nodes removed.

Significant predictors for a more extensive lymphadenectomy included age older than 40 years, white race, earlier year of diagnosis (1988-1993), and stage IB-IIA disease. Factors that predicted cancer-specific survival included age younger than 40 years, white race, later year of diagnosis (2000-2005), squamous histology, small tumor size, stage IA2, and the number of lymph nodes removed.

Overall, patients who had more than 30 nodes removed were 29% less likely to die than those who had 10 or fewer nodes removed. Extensive lymphadenectomy had no significant effect on survival for women with positive nodes. But among node-negative women, those with more than 30 nodes removed were 37% less likely to die than those who had fewer than 10 nodes removed.

The morbidity of lymphadenectomy should be weighed against the possible survival advantage, Dr. Shah advised.

The results were surprising in that women with positive nodes had no survival advantage with an extensive lymphadenectomy, but those with pathologically negative nodes did, she added in an interview. “Given that this is a retrospective analysis of the SEER database, we certainly need more information regarding comorbidities and factors that may have influenced patient and physician preferences for treatment,” said Dr. Shah.

Prospective, observational studies are needed to determine whether the results are an effect of extensive lymphadenectomy, and to determine how many lymph nodes constitute an adequate lymphadenectomy, as has been done in other types of cancers, she added.

Lymph node positivity is an important predictor of survival in cervical cancer, said study discussant Dr. Michael Gold of the University of Oklahoma in Oklahoma City.

In early-stage disease, lymph node positivity is among the most common criteria for adjuvant chemoradiation, said Dr. Gold. In theory, more-thorough lymphadenectomy in early-stage patients should allow clinicians to detect more occult metastatic disease, as has been shown with other cancers, including cancers of the colon, rectum, breast, lung, skin, and endometrium. Given the potential survival advantage that is seen with more thorough lymphadenectomy, more research is needed to make evidence-based recommendations.

My Take

Provocative Findings

In an interesting retrospective evaluation of the SEER database, investigators noted superior survival within the subgroup of individuals with node-negative cervical cancer who had the largest number of lymph nodes (more than 30) removed at the time of surgery, compared with those from whom fewer than 10 nodes were removed.

These provocative findings represent another example of the age-old debate as to whether the favorable outcome results from the elimination of “micrometastatic” cancer in these individuals who undergo extensive lymph node surgery, or whether the procedure has simply more carefully defined a population with “true” lymph node-negative disease.

In other words, the surgery has led to the detection of patients with microscopic, positive cancer who are no longer included in the lymph node-negative subgroup.

If this is the correct interpretation, then the procedure is helpful as a diagnostic strategy, but the performance of the surgery itself is not the reason for the improved outcome.

Only a well-designed and well-conducted, phase III, randomized trial can appropriately address and answer this important and clinically relevant issue.

MAURIE MARKMAN, M.D., is the vice president of clinical research at the University of Texas MD Anderson Cancer Center, Houston.

Vitals