Department of Internal Medicine, Wayne State University School of Medicine, Detroit, MI, USA.
Postgrad Med. 2012 May;124(3):59-70. doi: 10.3810/pgm.2012.05.2549.
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.
一项比较奥美沙坦酯（OM）和氯沙坦钾（LOS）在 1 期或 2 期高血压患者中的疗效和安全性的前瞻性、随机、双盲、滴定研究的探索性亚组分析报告如下。在 3-4 周的安慰剂导入期后，合格的患者接受每日一次 OM（第 1-4 周，20mg；第 5-8 周，40mg）、安慰剂加 OM（第 1-2 周，安慰剂；第 3-4 周，OM 20mg；第 5-8 周，OM 40mg）或 LOS（第 1-4 周，50mg；第 5-8 周，100mg）治疗。一部分患者接受了动态血压（BP）监测。根据高血压阶段评估的疗效终点是第 8 周时坐位袖带舒张压（SeDBP）与基线相比的平均变化（主要终点）；第 4 周和第 8 周时坐位袖带收缩压（SeSBP）和第 4 周时 SeDBP（次要终点）；以及第 8 周时平均 24 小时动态血压与基线相比的变化，以及 BP 目标达标（三级终点）。第 8 周时，1 期和 2 期高血压患者接受 OM 治疗的 SeDBP 分别较基线下降 9.9 和 9.5mmHg，接受 LOS 治疗的 SeDBP 分别下降 6.9 和 7.3mmHg（P=0.0095 和 P=0.0035）。总体而言，与接受 LOS 治疗的患者相比，63.6%接受 OM 治疗的 1 期高血压患者和 36.1%接受 OM 治疗的 2 期高血压患者的坐位血压（SeBP）＜140/90mmHg（P=0.0095），而 47.3%接受 LOS 治疗的 1 期高血压患者和 25.2%接受 LOS 治疗的 2 期高血压患者的 SeBP＜140/90mmHg（P=0.0022）。第 8 周时，与接受 LOS 治疗的患者相比，接受 OM 治疗的 2 期高血压患者的 24 小时动态血压降幅显著更大。奥美沙坦酯和氯沙坦钾耐受性良好，最常见的治疗中出现的不良事件是头痛。在 1 期或 2 期高血压患者中，每日一次使用最大剂量的 OM 可获得优于 LOS 的血压降低效果，且耐受性相似。
