Efficacy/safety of olmesartan medoxomil versus losartan potassium in patients by stage 1 or 2 hypertension.

An exploratory subgroup analysis of a prospective, randomized, double-blind, forced-titration study comparing the efficacy and safety of once-daily olmesartan medoxomil (OM) and losartan potassium (LOS) in patients with stage 1 or stage 2 hypertension is reported. After a 3- to 4-week placebo run-in period, eligible patients received once-daily OM (weeks 1-4, 20 mg; weeks 5-8, 40 mg), placebo plus OM (weeks 1-2, placebo; weeks 3-4, OM 20 mg; weeks 5-8, OM 40 mg), or LOS (weeks 1-4, 50 mg; weeks 5-8, 100 mg). A subset of patients underwent ambulatory blood pressure (BP) monitoring. Efficacy endpoints by hypertension stage were mean change from baseline in seated cuff diastolic BP (SeDBP) at week 8 (primary); seated cuff systolic BP (SeSBP) at week 4 and week 8, and SeDBP at week 4 (secondary); and the change from baseline in mean 24-hour ambulatory BP at week 8, and BP target achievement (tertiary). At week 8, patients with stage 1 and stage 2 hypertension had least-squares mean SeDBP reductions from baseline of 9.9 and 9.5 mm Hg, respectively, for OM treatment, and 6.9 and 7.3 mm Hg for LOS treatment (P = 0.0095 and P = 0.0035, respectively). Overall, 63.6% of patients with stage 1 hypertension treated with OM versus 47.3% treated with LOS (P = 0.0095) achieved an SeBP of < 140/90 mm Hg, while 36.1% of patients with stage 2 hypertension treated with OM versus 25.2% treated with LOS (P = 0.0022) achieved an SeBP of < 140/90 mm Hg. At week 8, OM-treated patients with stage 2 hypertension had a significantly greater reduction in least-squares mean 24-hour ambulatory BP versus LOS-treated patients. Olmesartan and LOS were well tolerated, and the most common treatment-emergent adverse event was headache. Once-daily, maximum doses of OM in patients with stage 1 or stage 2 hypertension achieved superior BP reductions versus LOS, with similar tolerability.