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ARTICLE | Clinical News

Olmesartan/amlodipine/hydrochlorothiazide: Phase III data

May 10, 2010 7:00 AM UTC

Data from the double-blind portion of the Phase III TRINITY trial in 2,492 patients with moderate-to-severe hypertension showed that the olmesartan/amlodipine/hydrochlorothiazide triple combination therapy met the primary endpoint of a significantly greater reduction in mean blood pressure from baseline to week 12 vs. corresponding dual combination therapies (37.1/21.8 mmHg vs. 27.5-30/15.1-18 mmHg, p<0.0001 for all). Additionally, a significantly greater proportion of patients treated with the triple combination therapy achieved their blood pressure goal (<140/90 mmHg or <130/80 mmHg for patients with diabetes, chronic renal disease or chronic cardiovascular disease) at week 12 vs. corresponding dual combination therapies (64.3% vs. 34.9-46.6%, p<0.0001 for all).

Furthermore, Daiichi said that blood-pressure lowering and the proportion of patients reaching their recommended blood pressure target was significantly greater for the triple combination therapy vs. corresponding dual combination therapies regardless of gender, age, race or disease severity. In a subset of 380 patients in which ambulatory blood pressure was measured, the triple combination therapy led to a mean 24-hour ambulatory blood pressure of 117/69 mmHg vs. 126-128/74-77 mmHg for corresponding dual combination therapies at week 12 (p<0.0001 for all). The triple combination therapy was well tolerated. Data were presented at the American Society of Hypertension meeting in New York. ...