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New Data Shows Investigational Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes
Date:6/28/2010

to 0.0042) and seated systolic blood pressure (P less than or equal to 0.0003) compared with each dual combination group.(4)

Additionally, in both the ethnicity and BMI subgroups of the study, the triple combination of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a greater percentage of patients reaching blood pressure goal compared with each dual combination group.(4) The incidence of treatment-emergent events in the BMI and ethnicity subgroup analyses was comparable between groups and adverse events were mild or moderate.(4)

TRINITY Study Design

At total of 2,492 patients with moderate to severe hypertension were enrolled into the Phase 3, multicenter, randomized, double-blind, parallel-group study, which examined the safety and efficacy of the triple combination of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg).(1,4) Patients were randomized to receive one of three dual combination therapies (n=2,456) or placebo (n=36) for the first two weeks of the study: olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or, amlodipine (10 mg) / hydrochlorothiazide (25 mg).(1,4)  After the first two weeks, until week four, the 36 patients on placebo were switched to one of the dual combination therapies.(1,4) At four weeks, a subset of patients from each of the three dual combination groups were switched to the triple combination therapy of olmesartan (40 mg) / amlodipine (10 mg) / hydrochlorothiazide (25 mg) and continued for 12 weeks (n=627).(1,4) The 12 week double-blind treatment period was followed by a 40 week open-label treatment period.(1,4) The 12-week results were presented at the American Society of Hypertension (ASH) annual meeting earlier this year, which found that the blood pressure-lowering and percentage of patients reaching the current
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SOURCE Daiichi Sankyo
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