Benz J, Oshrain C, Henry D, Avery C, Chiang Y T, Gatlin M
Foothill Clinic, Salt Lake City, Utah, USA.
J Clin Pharmacol. 1997 Feb;37(2):101-7. doi: 10.1002/j.1552-4604.1997.tb04767.x.
The present study compares the occurrence of a dry, persistent cough with doses of 80 mg of valsartan, 10 mg of lisinopril, or 25 mg of hydrochlorothiazide in patients with a history of angiotensin-converting enzyme inhibitor-induced cough. This was a randomized, double-blind, active-controlled, parallel group, multicenter trial involving 129 adult outpatients with essential hypertension. After confirmation of angiotensin-converting enzyme inhibitor-induced cough during a 2 to 4 week challenge with lisinopril (followed by a washout period of 2 weeks), patients were randomized to receive 6 weeks of double-blind treatment once daily with 80 mg valsartan, 10 mg lisinopril, or 25 mg hydrochlorothiazide. Assessments were made at baseline and after 3 and 6 weeks of treatment. Comparability of response to treatment was assessed by mean sitting diastolic and systolic blood pressure at the end of treatment. The occurrence of a dry, persistent cough was significantly less (P < 0.001) at 3 and 6 weeks with valsartan (19.5%) than with lisinopril (68.9%), with no significant difference between valsartan and hydrochlorothiazide (19.0%). There were no statistically significant differences in reduction of blood pressure among the three treatment groups. The overall incidence of adverse experiences, whether or not treatment-related, was highest for lisinopril (86.7%) compared with valsartan (57.1%), and hydrochlorothiazide (61.9%). A dry cough in the lisinopril group accounted for this difference. There were no clinically significant changes in physical signs or in results of clinical laboratory evaluations during double-blind treatment, except for from metabolic changes in 3 patients receiving hydrochlorothiazide. In hypertensive patients with a history of angiotensin-converting enzyme inhibitor-induced cough, a single daily dose of 80 mg of valsartan produced therapeutic efficacy comparable to lisinopril but with significantly less cough.
本研究比较了在有血管紧张素转换酶抑制剂诱发咳嗽病史的患者中，服用80毫克缬沙坦、10毫克赖诺普利或25毫克氢氯噻嗪后出现持续性干咳的情况。这是一项随机、双盲、活性药物对照、平行组、多中心试验，纳入了129例患有原发性高血压的成年门诊患者。在用赖诺普利进行2至4周激发试验（随后有2周的洗脱期）确诊血管紧张素转换酶抑制剂诱发咳嗽后，患者被随机分组，接受为期6周的双盲治疗，每日一次，分别服用80毫克缬沙坦、10毫克赖诺普利或25毫克氢氯噻嗪。在基线以及治疗3周和6周后进行评估。通过治疗结束时的平均坐位舒张压和收缩压评估治疗反应的可比性。在3周和6周时，服用缬沙坦（19.5%）出现持续性干咳的情况显著少于服用赖诺普利（68.9%）（P<0.001），缬沙坦与氢氯噻嗪（19.0%）之间无显著差异。三个治疗组在血压降低方面无统计学显著差异。不良事件的总体发生率，无论是否与治疗相关，赖诺普利组（86.7%）最高，相比之下缬沙坦组为（57.1%），氢氯噻嗪组为（61.9%）。赖诺普利组的干咳导致了这种差异。在双盲治疗期间，除了3例接受氢氯噻嗪治疗的患者出现代谢变化外，体征或临床实验室评估结果均无临床显著变化。在有血管紧张素转换酶抑制剂诱发咳嗽病史的高血压患者中，每日单次服用80毫克缬沙坦产生的治疗效果与赖诺普利相当，但咳嗽明显较少。
