Murray N H
Medical Research Department, ICI Pharmaceuticals, Macclesfield, UK.
Cardiology. 1991;79 Suppl 1:22-9. doi: 10.1159/000174903.
A large co-ordinated multinational clinical-trial programme in hypertension has provided comparative data on adverse events in patients on lisinopril (n = 318) compared with enalapril (n = 321) and in 230 patients on lisinopril versus captopril (n = 235). The three groups were demographically well matched with regard to age and duration of treatment. However, in comparison with the lisinopril group, the captopril-treated group had a slightly higher proportion of males (NS). The incidence of adverse events on lisinopril was similar to that on enalapril (10.4 vs. 8.7%, NS) and captopril (11.7 vs. 11.9%, NS). The incidence of withdrawals was similar on lisinopril and enalapril (1.9 vs. 1.9%, NS) and captopril (4.8 vs. 3.0%, NS). The most frequently reported events affected the digestive, respiratory, or nervous and psychiatric systems of the body. The pattern of events and withdrawals was similar for all three drugs. The incidence of laboratory changes for lisinopril versus enalapril and lisinopril versus captopril was similar. The safety profiles of all three drugs were comparable in young and elderly patients. First-dose hypotension was reported for 2 of 548 patients on lisinopril, and renal failure was reported for 3 of 286 patients on enalapril. Overall, the events reflected the class-specific effects previously identified for angiotensin-converting enzyme inhibitors. The data indicate that long-acting angiotensin-converting enzyme inhibitors do not impose any additional side-effect risk in hypertension.
一项大规模的高血压多中心协调临床试验项目提供了比较数据，涉及赖诺普利组（n = 318）与依那普利组（n = 321）的不良事件，以及230例使用赖诺普利的患者与235例使用卡托普利的患者的不良事件。这三组在年龄和治疗时长方面在人口统计学上匹配良好。然而，与赖诺普利组相比，卡托普利治疗组男性比例略高（无统计学意义）。赖诺普利的不良事件发生率与依那普利相似（10.4%对8.7%，无统计学意义），与卡托普利也相似（11.7%对11.9%，无统计学意义）。停药发生率在赖诺普利和依那普利之间相似（1.9%对1.9%，无统计学意义），与卡托普利相比也相似（4.8%对3.0%，无统计学意义）。最常报告的事件影响身体的消化、呼吸或神经及精神系统。三种药物的事件和停药模式相似。赖诺普利与依那普利以及赖诺普利与卡托普利的实验室检查变化发生率相似。所有三种药物在年轻和老年患者中的安全性概况相当。赖诺普利治疗的548例患者中有2例报告了首剂低血压，依那普利治疗的286例患者中有3例报告了肾衰竭。总体而言，这些事件反映了先前确定的血管紧张素转换酶抑制剂类特异性效应。数据表明，长效血管紧张素转换酶抑制剂在高血压治疗中不会带来任何额外的副作用风险。
