A multicenter, randomized double-blind study of valsartan/hydrochlorothiazide combination versus amlodipine in patients with mild to moderate hypertension

Objective To compare the antihypertensive efficacy and tolerability of a on ce-daily fixed valsartan/ hydrochlorothiazide (HCTZ) combination and amlodi pine in subjects with mild-to-moderate hypertension. Subjects and setting In this multicentre, double-blind, randomized, compara tive trial, 690 patients with sifting systolic blood pressure (BP) greater than or equal to 160 mmHg and sitting diastolic BP greater than or equal to 95 mmHg at the end of a 2-week placebo wash-out period were randomized to valsartan-based treatment (n = 342) or amlodipine (n = 348). Methods The patients received valsartan 80 mg o.d. or amlodipine 5 mg o.d f or 4 weeks; in the case of an unsatisfactory blood pressure response, the t reatments could be respectively changed to the fixed combination of valsart an 80 mg + HCTZ 12.5 mg o.d. or amlodipine 10 mg o.d. for a further 8 weeks . Results Both treatment approaches decreased systolic blood pressure and dia stolic blood pressure to the same extent The rate of responders to treatmen t at the end of fourth week (before up-titration) was 57.4% among the valsa rtan-treated patients and 61.9% among the amlodipine-treated patients (ns). At the end of the study, the rate of responders was not significantly diff erent between the two groups (74.9 versus 72.1%). Valsartan-based treatment had a slightly lower incidence of adverse events (1.5 versus 5.5%; P = 0.0 06). Conclusions The results of this trial demonstrate that the valsartan/hydroc hlorothiazide combination and amlodipine are equally effective in lowering BID, and that the combination is better tolerated. (C) 2001 Lippincott Will iams & Wilkins.