奥美沙坦酯与氯沙坦钾治疗中国轻、中度原发性高血压患者8周的疗效与安全性比较

目的 通过与氯沙坦钾比较评价奥美沙坦酯治疗轻、中度原发性高血压患者的疗效和安全性。方法采用随机、双盲、双模拟、阳性对照、平行分组、多中心临床试验方法。共入选287例轻、中度原发性高血压患者,按照1：1的比例随机分组,分别接受奥美沙坦酯20mg或氯沙坦钾50mg,每天1次口服治疗。在用药4周后对患者进行血压评价,如果患者舒张压（DBP）仍≥90mmHg（1mmHg=0．133kPa）,则试验药物剂量加倍,直至8周试验结束;治疗4周后DBP〈90mmHg的患者则维持原剂量继续治疗至第8周。结果（1）治疗4周后,奥美沙坦酯组坐位DBP谷值平均下降11．72mmHg,氯沙坦钾组平均下降9．23mmHg,两组间比较P=0．004。（2）治疗8周后,奥美沙坦酯组坐位DBP谷值平均下降12．94mmHg,氯沙坦钾组平均下降11．01mmHg,两组间比较P=0．035。（3）治疗4周后,奥美沙坦酯组有效数为81例（65．3％）,氯沙坦钾组有效数为68例（52．7％）,两组间比较P=0．028;治疗8周后,两组有效病例数和有效率相当,P〉0．05。（4）治疗8周后,24h动态血压监测显示,奥美沙坦酯组DBP和SBP的个体和总体谷／峰比值均高于氯沙坦钾组,奥美沙坦酯在24h内的作用持续时间比氯沙坦钾组长。（5）奥美沙坦酯组和氯沙坦钾组发生的与试验药物有关的不良事件的发生率分别为10．5％和13．9％,P〉0．05。结论奥美沙坦酯每日口服20～40mg能够有效、安全地治疗高血压。与氯沙坦钾每日口服50-100mg相比,奥美沙坦酯的降压效果优于氯沙坦钾。

Efficacy and safety of olmesartan medoxomil versus losartan potassium in Chinese patients with mild to moderate essential hypertension

OBJECTIVE: To evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension. METHOD: This is a randomized, double-blind, double-dummy, active-controlled, parallel, multi-center study. After a 2-week placebo run-in period, a total of 287 eligible subjects were randomized at 1:1 ratio to receive olmesartan medoxomil 20 mg or losartan potassium 50 mg, once daily for 8 weeks. The blood pressure was assessed after 4 weeks treatment. If the subject's seating diastolic blood pressure (SeDBP) was still >or=90 mm Hg, the dosage was doubled for another 4 weeks; for those subjects whose SeDBP was <90 mm Hg after 4-week treatment, the initial dosage remained unchanged and the treatment continued until completion of the study. RESULTS: (1) The mean trough reduction in SeDBP from baseline in olmesartan group was significantly greater than that in losartan group after 4 weeks (11.72 mm Hg vs 9.23 mm Hg, P=0.004) and 8 weeks treatment (12.94 mm Hg vs 11.01 mm Hg, P=0.035). (2) The number and percentage of responders in olmesartan group (81, 65.3%) were statistically higher than those (68, 52.7%) in losartan group (P=0.028) after 4 weeks treatment and were similar between the two groups after 8 weeks treatment (P>0.05). (3) Individual and overall trough/peak ratios of DBP and SBP in 24-hour ambulatory blood pressure monitoring were higher in olmesartan group than losartan group. The hypotensive effect of olmesartan was more durable than losartan at 24 hour interval. (4) The incidence of study drug-related adverse events (AEs) in olmesartan group (10.5%) was similar as that in losartan group (13.9%, P>0.05). Most of these AEs were mild and transient. CONCLUSION: This study shows that olmesartan medoxomil, at oral dose of 20 mg-40 mg once daily was effective and safe for hypertension treatment and the hypotensive effect was superior to losartan potassium (50 mg-100 mg once daily).