科研之友
微信
新浪微博
Facebook
分享链接
摘要
Objective: To evaluate the comparative efficacy and safety of once-daily olmesartan medoxomil (OM) and losartan potassium (LOS) in patients with hypertension. Methods: This was a multicenter, prospective, randomized, double-blind, active-comparator, forced-titration study. After a 3-week placebo run-in, 941 patients were randomized in an 8:1:9 ratio to once-daily treatment with OM (20 mg for 4 weeks, then OM 40 mg for 4 weeks [n = 420]), placebo plus OM (placebo for 2 weeks, then OM 20 mg for 2 weeks and OM 40 mg for 4 weeks [n = 52]), or LOS (50 mg for 4 weeks, then LOS 100 mg for 4 weeks [n = 469]). A subset of 246 patients underwent ambulatory blood pressure (BP) monitoring. The primary endpoint was mean change from baseline in trough seated cuff diastolic BP (SeDBP) at week 8. Secondary end-points were mean changes from baseline in trough SeDBP at week 4 and seated systolic BP (SeSBP) at weeks 4 and 8. Tertiary endpoints included change from baseline in mean 24-hour ambulatory BP at weeks 4 and 8 and percentage of patients achieving seated cuff BP (SeBP) goal of < 140/90 mm Hg and mean 24-hour ambulatory BP target of < 130/80 mm Hg at weeks 4 and 8. Results: At week 8, least-squares (LS) mean (+/- standard error) SeDBP reductions from baseline were 9.7 +/- 0.5 and 7.1 +/- 0.5 mm Hg (treatment difference: -2.5 +/- 0.6 mm Hg; P < 0.0001) and LS mean SeSBP reductions were 13.6 +/- 0.7 and 9.7 +/- 0.7 mm Hg (treatment difference: -3.9 +/- 1.0 mm Hg; P = 0.0001) for OM versus LOS, respectively. A significantly greater proportion of patients receiving OM reached SeBP goal of < 140/90 mm Hg at week 8. There was a similar incidence of adverse events with OM and LOS. Conclusion: Treatment with low-and high-dose OM achieved superior SeBP reductions compared with low-and high-dose LOS, resulting in significantly more patients achieving SeBP goal, with similar tolerability.
- 出版日期2011-1
