Brunner Hans R
Division of Hypertension and Vascular Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Clin Ther. 2004;26 Suppl A:A28-32. doi: 10.1016/s0149-2918(04)90143-9.
Olmesartan medoxomil is an angiotensin II receptor antagonist that selectively and competitively inhibits the angiotensin II type 1 receptor.
This article reviews the results of some key studies that assessed the efficacy and tolerability of olmesartan in patients with hypertension.
Olmesartan has been investigated in several clinical studies. This article reports on data from 1 such study with a prospective, randomized, double-blind, placebo-controlled, parallel-group, dose-finding design in patients with mild to moderate hypertension (baseline mean sitting diastolic blood pressure, 100-114 mm Hg). The results from a meta-analysis of 7 randomized, double-blind, placebo-controlled studies are also presented.
In the dose-finding study, 792 patients were randomized to olmesartan (2.5-80 mg) or placebo once daily, and changes were recorded in trough mean sitting diastolic and systolic blood pressures from baseline to the end of a 12-week treatment period. For the meta-analysis, 3055 patients were randomized to treatment; 2511 received olmesartan. In the dose-finding study as well as in the meta-analysis, olmesartan (2.5-80 mg once daily) produced a dose-dependent decrease in diastolic and systolic blood pressures, and at a dose of 10 to 80 mg showed significant superiority in reducing diastolic blood pressure over placebo (P < 0.05). The 20-mg dose was considered optimal, with a responder rate of 70%. Furthermore, in a 2-year study with 462 patients, olmesartan had a good safety profile and was well tolerated. The results of the clinical studies in >3000 patients receiving olmesartan showed that the frequency and profile of adverse events with olmesartan were generally similar to those with placebo; the frequency of adverse events was not dose related. Olmesartan, with or without hydrochlorothiazide, was well tolerated over 2 years of treatment.
奥美沙坦酯是一种血管紧张素II受体拮抗剂，可选择性且竞争性地抑制1型血管紧张素II受体。
本文回顾了一些评估奥美沙坦对高血压患者疗效和耐受性的关键研究结果。
在多项临床研究中对奥美沙坦进行了调查。本文报告了1项此类研究的数据，该研究采用前瞻性、随机、双盲、安慰剂对照、平行组、剂量探索设计，纳入轻度至中度高血压患者（基线平均坐位舒张压为100 - 114 mmHg）。还呈现了7项随机、双盲、安慰剂对照研究的荟萃分析结果。
在剂量探索研究中，792例患者被随机分为每日一次服用奥美沙坦（2.5 - 80 mg）或安慰剂组，并记录从基线到12周治疗期末的谷值平均坐位舒张压和收缩压变化。对于荟萃分析，3055例患者被随机分配接受治疗；2511例接受奥美沙坦治疗。在剂量探索研究以及荟萃分析中，奥美沙坦（每日一次2.5 - 80 mg）可使舒张压和收缩压呈剂量依赖性下降，且在10至80 mg剂量时，在降低舒张压方面显著优于安慰剂（P < 0.05）。20 mg剂量被认为是最佳剂量，有效率为70%。此外，在一项针对462例患者的2年研究中，奥美沙坦具有良好的安全性，耐受性良好。对3000多名接受奥美沙坦治疗患者的临床研究结果表明，奥美沙坦不良事件的发生频率和类型通常与安慰剂相似；不良事件的发生频率与剂量无关。奥美沙坦单独或与氢氯噻嗪联合使用，在2年治疗期间耐受性良好。
