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Fixed-dose, triple-combination therapy with olmesartan medoxomil, amlodipine, hydrochlorothiazide lowers BP in patients with hypertension, diabetes, TRINITY data suggest

Tuesday, July 13 2010 | Comments

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What's This? In patients with both hypertension and diabetes, a fixed-dose tablet containing olmesartan medoxomil 40 mg, amlodipine besylate 10 mg, and hydrochlorothiazide 25 mg reduces blood pressure (BP) significantly more than does treatment with any 2 combinations of these 3 drugs, according to new data from the TRINITY trial.
 
During the double-blind trial, researchers compared the 3-drug combination with the 2-drug combinations of its component therapies (olmesartan medoxomil 40 mg plus amlodipine 10 mg, olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg, or amlodipine 10 mg plus hydrochlorothiazide 25 mg) in 2,492 participants with moderate to severe hypertension.
 
As previously reported, the 12-week results for the entire TRINITY population were presented in New York at the American Society of Hypertension 25th Annual Scientific Meeting and Exposition and showed that the triple-combination therapy was associated with significantly greater reductions in BP and greater percentages of patients achieving BP goals, regardless of age, sex, race, or hypertension severity (P<.0001).
 
The current analysis was a prespecified subgroup analysis of 387 participants with diabetes.
 
In this subgroup, the combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide was associated with least squares mean reductions in systolic BP and diastolic BP of 37.9 mm Hg and 22 mm Hg, respectively, from baseline to week 12. The corresponding reductions with the dual combinations of the component therapies ranged from 26.4 mm Hg to 28 mm Hg (systolic BP) and from 14.7 mm Hg to 17.6 mm Hg (diastolic BP; P<=.0013 for all comparisons).
 
In addition, 41.1% of the patients with diabetes who received the triple-combination therapy achieved a BP <130/80 mm Hg compared with 10.1% to 16.3% of the patients in the 2-drug-combination groups who did so (P<=.0002 for all comparisons).
 
Daiichi Sankyo Inc., the company developing the fixed-dose, 3-drug combination tablet, noted that the therapy was well-tolerated in these patients, with most adverse events characterized as mild or moderate.
 
In the overall study population, drug-related treatment-emergent adverse events occurred in 25.4% of all participants. There were more discontinuations due to adverse events in the triple-combination-therapy group (4%) than in the dual-combination groups (1%-2.1%). Some of these adverse events, such as dizziness and hypotension, could potentially be attributed to the pharmacodynamic effect of the 3-drug combination, Daiichi Sankyo noted. Other adverse events leading to discontinuation included peripheral edema.
 
The fixed-dose, 3-drug combination therapy is currently under review by the Food and Drug Administration as a treatment for hypertension.
 
These data were presented in Orlando, Fla., at the American Diabetes Association's 70th Annual Scientific Sessions.

This information concerns a use that has not been approved by the FDA.

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