Trinity Hypertension Research Institute, Punzi Medical Center, Carrollton, TX 75006, USA.
Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.
A predefined exploratory analysis of a prospective, randomized, double-blind, forced-titration study of olmesartan medoxomil (OM) versus losartan potassium (LOS) in subjects with hypertension not previously or previously treated with antihypertensive medication is reported.
The study included a 3-4-week placebo run-in and an 8-week active treatment period: OM (weeks 1-4, OM 20 mg; weeks 5-8, OM 40 mg); placebo + OM (weeks 1-2, placebo; weeks 3-4, OM 20 mg; weeks 5-8, OM 40 mg); and LOS (weeks 1-4, LOS 50 mg; weeks 5-8, LOS 100 mg). Analyses focused on comparison of OM and placebo + OM combined versus LOS. Efficacy endpoints were mean change from baseline in seated cuff diastolic blood pressure (SeDBP) at week 8 (primary); seated cuff systolic blood pressure (SeSBP) at weeks 4 and 8, and SeDBP at week 4 (secondary), and BP target achievement (tertiary).
The randomized population (n = 941) had a mean ± SD age of 51.9 ± 9.7 years, 54.5% were male, and 20.1% were naïve to antihypertensive medication. For treatmentnaïve subjects, baseline seated BP (SeBP) (±SD) was 157.4 (±10.9)/101.8 (±4.3) mmHg with OM and 156.3 (±10.8)/101.1 (±3.9) mmHg with LOS, while non-naïve subjects had 158.4 (±10.2)/100.9 (±4.0) mmHg with OM and 158.8 (±10.1)/101.3 (±4.2) mmHg with LOS. OM monotherapy produced significantly greater changes in least-squares mean (±SE) SeDBP compared with LOS in both treatment-naïve (-9.7 [1.0] vs. -6.6 [1.0] mmHg; P = 0.0232 vs. LOS) and non-naïve subjects (-9.6 [0.5] vs. -7.3 [0.5] mmHg; P = 0.0013 vs. LOS). A significantly greater proportion of patients achieved the SeBP goal of <140/90 mmHg with OM compared with LOS in treatment-naïve (34.1% vs. 19.0%, respectively; P = 0.0109) and non-naïve subjects (31.0% vs. 19.6%; P = 0.0008).
Overall, OM monotherapy resulted in significantly greater SeBP reductions and greater SeBP goal achievement than LOS, irrespective of previous medication use. Both OM and LOS therapy were well tolerated.
本文报道了一项前瞻性、随机、双盲、滴定研究的探索性分析，该研究比较了奥美沙坦酯（OM）与氯沙坦钾（LOS）在未接受或接受过降压药物治疗的高血压患者中的疗效。
该研究包括 3-4 周的安慰剂导入期和 8 周的活性治疗期：OM（第 1-4 周，OM 20mg；第 5-8 周，OM 40mg）；安慰剂+OM（第 1-2 周，安慰剂；第 3-4 周，OM 20mg；第 5-8 周，OM 40mg）；LOS（第 1-4 周，LOS 50mg；第 5-8 周，LOS 100mg）。分析重点比较了 OM 和安慰剂+OM 联合治疗与 LOS 的疗效。主要疗效终点为第 8 周坐位袖带舒张压（SeDBP）的平均变化（基础值）（主要终点）；第 4 周和第 8 周的坐位袖带收缩压（SeSBP）和第 4 周的 SeDBP（次要终点）以及血压目标达标（次要终点）。
随机分组人群（n=941）的平均年龄±标准差为 51.9±9.7 岁，54.5%为男性，20.1%为初次接受降压药物治疗。对于初次接受降压药物治疗的患者，基线坐位血压（SeBP）（±标准差）为 OM 组 157.4（±10.9）/101.8（±4.3）mmHg，LOS 组 156.3（±10.8）/101.1（±3.9）mmHg，而非初次接受降压药物治疗的患者 OM 组为 158.4（±10.2）/100.9（±4.0）mmHg，LOS 组为 158.8（±10.1）/101.3（±4.2）mmHg。OM 单药治疗与 LOS 相比，在初次接受降压药物治疗和非初次接受降压药物治疗的患者中，坐位舒张压（SeDBP）的最小二乘均数（±SE）变化均显著更大，分别为-9.7（1.0）与-6.6（1.0）mmHg（P=0.0232 与 LOS）和-9.6（0.5）与-7.3（0.5）mmHg（P=0.0013 与 LOS）。与 LOS 相比，OM 组达到坐位血压目标（<140/90mmHg）的患者比例在初次接受降压药物治疗和非初次接受降压药物治疗的患者中均显著更高，分别为 34.1%和 31.0%（分别为 P=0.0109 和 P=0.0008）。
总体而言，与 LOS 相比，OM 单药治疗可显著降低 SeBP，并且更高比例的患者达到 SeBP 目标。无论是否有过药物治疗，OM 和 LOS 治疗均耐受良好。
