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

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] 40mg, amlodipine besylate [AML] 10mg, and hydrochlorothiazide [HCTZ] 25mg) 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/-18.0mmHg) compared with the 3 dual-combination regimens (OM 40 mg/AML 10mg: -23.5/-13.9, OM 40 mg/HCTZ 25mg: -23.9/-14.5, and AML 10 mg/HCTZ 25mg: -18.5 mm Hg/-10.7mmHg; P