Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Drugs. 2010 Dec 24;70(18):2439-47. doi: 10.2165/11206310-000000000-00000.
Olmesartan medoxomil is an orally administered angiotensin II receptor antagonist, selective for the angiotensin II type 1 receptor, which has established antihypertensive efficacy in adults. In children and adolescents with hypertension (n = 302), oral olmesartan medoxomil significantly and dose-dependently reduced seated systolic blood pressure (BP) and seated dystolic BP from baseline (the primary endpoint) in a 3-week, dose-response period in a well designed phase II/III clinical trial. Patients received olmesartan medoxomil high dose (20 or 40 mg once daily depending on bodyweight) or low dose (2.5 or 5.0 mg once daily depending on bodyweight). The response was significant for both cohorts, which were stratified by race (cohort A was mixed race [62% White] and cohort B was 100% Black). In addition, BP control was maintained in olmesartan recipients relative to placebo recipients in cohort A and the combined cohort A + B, but not for patients in cohort B, during a placebo-controlled withdrawal period of this trial. Oral olmesartan medoxomil was generally well tolerated in children and adolescents with hypertension. The majority of adverse events were of mild to moderate intensity.
奥美沙坦酯是一种口服血管紧张素 II 受体拮抗剂，对血管紧张素 II 型 1 受体具有选择性，已在成人中确立了降压疗效。在高血压的儿童和青少年（n=302）中，奥美沙坦酯口服在一项精心设计的 II/III 期临床试验的 3 周剂量反应期内，从基线显著且剂量依赖性地降低了坐位收缩压（BP）和坐位舒张压（BP）（主要终点）。患者接受奥美沙坦酯高剂量（根据体重每天一次 20 或 40mg）或低剂量（根据体重每天一次 2.5 或 5.0mg）。两个队列的反应均具有统计学意义，这两个队列按种族分层（队列 A 为混合种族[62%为白人]，队列 B 为 100%为黑人）。此外，在该试验的安慰剂对照停药期内，奥美沙坦酯组相对于安慰剂组在队列 A 和队列 A+B 中均保持了 BP 控制，但队列 B 中的患者则不然。奥美沙坦酯在高血压的儿童和青少年中通常具有良好的耐受性。大多数不良事件为轻度至中度。
