Comparison of monotherapy with irbesartan 150 mg or amlodipine 5 mg for treatment of mild-to-moderate hypertension

Abstract

Objective. The primary objective of this study was to compare the antihypertensive efficacy of the angiotensin II receptor blocker irbesartan 150 mg and the calcium channel blocker amlodipine 5 mg in the treatment of patients with seated diastolic blood pressure (DBP) 95-110 mmHg. Design. Multicentre, randomised, double-blind, comparative pilot study. Methods. Subjects were 18-65 years of age, with DBP 95-110 mmHg, and of non-African American origin. Following a three-week, single-blind, placebo lead-in period, 181 subjects were randomised in a 1:1 ratio to receive once-daily irbesartan 150 mg (n=89) or amlodipine 5 mg (n=92) for four weeks. Trough (24±3 hours post-dosing) BP measurements were obtained at baseline and at Weeks 2 and 4 under standardised, controlled conditions. Response was defined as DBP <90 mmHg or a reduction from baseline of ≥40 mmHg. Results. After four weeks of treatment, the mean (±SE) decrease from baseline in DBP was 9.4±0.6 mmHg in the irbesartan group vs. 9.6±0.6 mmHg in the amlodipine group (p=0.806). The mean decrease from baseline in seated systolic BP was 12.2±1.0 mmHg in the irbesartan group vs. 12.0±1.0 mmHg in the amlodipine group (p=0.885). Overall, 62% of subjects in the irbesartan group and 63% in the amlodipine group had a response (p=0.609), and 54% and 56% of patients (p=0.596), respectively, had their DBP normalised (<90 mmHg). Adverse events were reported by 21.3% of patients receiving irbesartan and 20.7% receiving amlodipine. Conclusions. Irbesartan 150 mg demonstrated comparable efficacy to amlodipine 5 mg, thereby confirming its value as an antihypertensive treatment option in non-African American patients with DBP 95-110 mmHg.