Two Combination Therapies Work Equally Well to Reduce Acne

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

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

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

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

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

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

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

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

The researchers had no financial conflicts to disclose.

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

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

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

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

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

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

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

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

The researchers had no financial conflicts to disclose.

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

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

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

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

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

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

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

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

The researchers had no financial conflicts to disclose.

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Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.

Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.

Disclosures: The researchers had no financial conflicts to disclose.

Study: Aliskiren Dual Therapy Beats Amlodipine for Blood Pressure Control in Blacks

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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WHO Declares End to 2009 H1N1 Influenza Pandemic

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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.

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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.

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Acne Scar Patients Give Thumbs Up to CO2 Laser Treatment

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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.

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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.

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Decrease in Heart Function Might Impact Brain Aging

Tough to Distinguish From Normal Aging
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Decrease in Heart Function Might Impact Brain Aging

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.

Body

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

The cross-sectional nature of the study by Dr. Jefferson and her colleagues prevents 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, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.

The evidence is not yet clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. But data from previous studies indicate that vascular risk factors, including decreased heart function, can contribute to dementia (including Alzheimer’s disease and other vascular cognitive disorders). Therefore, more research is needed to explore how addressing vascular risk factors could modify the course of different types of dementias.

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

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

The cross-sectional nature of the study by Dr. Jefferson and her colleagues prevents 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, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.

The evidence is not yet clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. But data from previous studies indicate that vascular risk factors, including decreased heart function, can contribute to dementia (including Alzheimer’s disease and other vascular cognitive disorders). Therefore, more research is needed to explore how addressing vascular risk factors could modify the course of different types of dementias.

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

Body

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

The cross-sectional nature of the study by Dr. Jefferson and her colleagues prevents 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, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.

The evidence is not yet clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. But data from previous studies indicate that vascular risk factors, including decreased heart function, can contribute to dementia (including Alzheimer’s disease and other vascular cognitive disorders). Therefore, more research is needed to explore how addressing vascular risk factors could modify the course of different types of dementias.

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

Title
Tough to Distinguish From Normal Aging
Tough to Distinguish From Normal Aging

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.

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Decrease in Heart Function Might Impact Brain Aging
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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.

Triple-Drug Pill Shows Promise to Reduce BP

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Triple-Drug Pill Shows Promise to Reduce BP

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.

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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.

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Decrease in Heart Function Might Impact Brain Aging

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Decrease in Heart Function Might Impact Brain Aging

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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