Why the study?
Does a triple-combination regimen of olmesartan, amlodipine, and hydrochlorothiazide reduce ambulatory blood pressure in patients with moderate to severe hypertension compared to dual-combination regimens?
Does a triple-combination regimen of olmesartan, amlodipine, and hydrochlorothiazide reduce ambulatory blood pressure in patients with moderate to severe hypertension compared to dual-combination regimens?
Triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide provides superior 24-hour ambulatory blood pressure reduction compared to dual-combination therapies in patients with moderate to severe hypertension.
Supports triple olmesartan/amlodipine/HCTZ for moderate-severe hypertension; extends RCT evidence for ambulatory BP lowering over dual regimens.
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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Izzo et al. (2011) studied this question.
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