Results of an Olmesartan Medoxomil–Based Treatment Regimen in Hypertensive Patients


Suzanne Oparil, MD, Vascular Biology and Hypertension Program, Division of Cardiovascular Diseases, University of Alabama at Birmingham, 703 19th Street South, ZRB 1034, Birmingham, AL 35294-0007


The efficacy and safety of an olmesartan medoxomil (OM)–based treatment algorithm was tested in a double-blind, randomized, placebo-controlled titration study in 276 patients with stage 1 or 2 hypertension. After placebo run-in, patients were randomized to placebo (12 weeks) or OM 20 mg/d (weeks 1–3). OM was up-titrated to 40 mg/d (weeks 4–6), then OM/hydrochlorothiazide (HCTZ) 40/12.5 mg/d (weeks 7–9) and OM/HCTZ 40/25 mg/d (weeks 10–12) were started if blood pressure (BP) remained ≥120/80 mm Hg at each time interval. End points were change from baseline in mean systolic BP (primary) and mean diastolic BP (secondary). OM-based treatment was well tolerated and changed BP by −22.3/−12.1 mm Hg from baseline vs −0.1/+0.8 mm Hg for placebo (P<.0001). Cumulative goal BP (<140/90 mm Hg) was achieved in 74.1% and 30.7% of OM- compared with placebo-treated patients, respectively (P<.0001). BP normalized (<120/80 mm Hg) in 44.8% of OM- vs 1.4% of placebo-treated patients with stage 1 hypertension (P<.0001).