24-Hour Efficacy and Safety of Triple-Combination Therapy With Olmesartan, Amlodipine, and Hydrochlorothiazide: The TRINITY Ambulatory Blood Pressure Substudy

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Abstract

This 12-week, multicenter, randomized, double-blinded, 4-arm study in 440 patients with moderate to severe hypertension compared ambulatory blood pressure (ABP) responses with a triple-combination regimen (olmesartan medoxomil [OM] 40 mg, amlodipine besylate [AML] 10 mg, and hydrochlorothiazide [HCTZ] 25 mg) and its component dual-combination regimens at similar doses. At week 12, the triple combination resulted in a greater reduction in mean 24-hour systolic and diastolic blood pressure (−30.3/−18.0 mm Hg) compared with the 3 dual-combination regimens (OM 40 mg/AML 10 mg: −23.5/−13.9, OM 40 mg/HCTZ 25 mg: −23.9/−14.5, and AML 10 mg/HCTZ 25 mg: −18.5 mm Hg/−10.7 mm Hg; P<.0001 each). Greater efficacy was also found during daytime and nighttime hours and during the last 6, 4, or 2 hours of the dosing interval. The authors conclude that the triple combination of OM 40 mg/AML 10 mg/HCTZ 25 mg demonstrated superior efficacy and sustained reductions in ABP compared with its dual-combination components.

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