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.
Department of Internal Medicine, Wayne State University School of Medicine, Detroit, MI, USA. jflack@med.wayne.edu
John M
JM
Flack
Alan
A
Graff
Wei
W
Li
Kathleen J
KJ
Chavanu
D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018660:Blood Pressure Monitoring, Ambulatory; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016018:Least-Squares Analysis; D019808:Losartan / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil; D010919:Placebos; D011446:Prospective Studies; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D007093:Imidazoles; D010919:Placebos; D013777:Tetrazoles; D000068557:Olmesartan Medoxomil; D019808:Losartan