奥美沙坦酯与缬沙坦治疗轻中度原发性高血压的疗效与安全性比较

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

目的评价奥美沙坦酯与缬沙坦(均为抗高血压药,血管紧张素Ⅱ受体拮抗剂)治疗轻中度原发性高血压的疗效和安全性比较。方法入选240例轻、中度原发性高血压患者,按照1∶1随机分组,分别接受奥美沙坦酯20～40mg·d-1或缬沙坦80～160mg·d-1治疗,共8周。结果治疗4周后,奥美沙坦酯组与缬沙坦组SeDBP平均下降(10.58±6.82)mmHg及(9.38±7.16)mmHg;奥美沙坦组与缬沙坦组分别有60%及61.74%患者剂量加倍,加量有效率分别为52.22%及51.85%。治疗8周后,2组SeDBP平均下降(15.72±6.03)mmHg及(14.12±6.79)mmHg。治疗4周后,奥美沙坦酯组与缬沙坦组的药物不良反应发生率分别为3.33%及7.5%(P>0.05)。结论每日1次口服奥美沙坦酯胶囊20～40mg·d-1,能24h平稳降压,其8周总有效率79.65%;与缬沙坦80～160mg.d-1的降压疗效相近。2组药物不良反应发生率无显著差异。

Objective To evaluate the efficacy and safety of olmesartan medoxomil compared with valsartan in patients with mild to moderate essential hypertension. Methods A total 240 eligible subjects were randomized at 1∶1 ratio to receive olmesartan medoxomil 20-40 mg or valsartan 80-160 mg,once daily for 8 weeks. Results The mean trough reduction in SeDBP from baseline was no difference between olmesartan medoxomil and valsartan groups after 4 weeks [（10.58±6.82） mmHg vs （9.38±7.16） mmHg,P〉0.05] and 8 weeks weeks treatment [（ 15.72 ± 6. 03） mmHg vs （14.12 ± 6.79） mmHg,P〉0.05]. After 4 weeks treatment, the patients with double dose in olmesartan and valsartan group were 60% and 61.74%, the double dose efficiency were 52.22% and 51.85% respectively（ P 〉 0.05 ）. The incidence of study drug-related adverse event （AE） in olmesartan group （3.33%） was similar to that in valsartan group （7.5%, P 〉0. 05）. No SAE was occurred. Conclusion Olmesartan medoxomil at oral dase of 20 - 40 mg once daily was effective and safe for hypertension treatment and effect was similar to valsartan 80 - 160 mg once daily.