Morisco C, Condorelli M, Crepaldi G, Rizzon P, Zardini P, Villa G, Argenziano L, Trimarco B
Istituto di Medicina Interna, Università Federico II Napoli, Italy.
Cardiovasc Drugs Ther. 1997 Mar;11(1):63-9. doi: 10.1023/a:1007704024393.
The present study was performed in order to compare the efficacy, safety, and tolerability of lisinopril, a long-acting angiotensin-converting enzyme (ACE) inhibitor, with captopril, the shorter acting ACE inhibitor available, in the treatment of elderly patients (mean age 70 +/- 0.5 years) with congestive heart failure (mean left ventricular ejection fraction 33.5 +/- 1%). The study was organized according to a double-blind, parallel-group, randomized multicenter protocol. After a 14-day placebo run-in period, patients were randomized to receive either lisinopril 5 mg orally once per day or captopril 12.5 mg orally once per day. The dose of the study drug could be doubled at 2-week intervals for 6 weeks. The maximal dose was lisinopril 20 mg once per day or captopril 25 mg twice per day. The addition of either captopril or lisinopril to a regimen of diuretics caused a significant increase in exercise tolerance assessed by bicycle ergometry after 12 weeks of treatment (530 +/- 21 seconds vs. 431 +/- 13 seconds, p < 0.01; 555 +/- 19 seconds vs. 463 +/- 12 seconds, p < 0.01, respectively). Both drugs significantly increased left ventricular ejection fraction and stroke volume, were equally effective in improving NYHA class, and were well tolerated, with no differences detectable between treatments. The results of this study indicate that lisinopril 5-20 mg once daily is at least as effective and well tolerated as captopril 12.5-50 mg daily in the treatment of elderly patients with congestive heart failure.
本研究旨在比较长效血管紧张素转换酶(ACE)抑制剂赖诺普利与现有的短效ACE抑制剂卡托普利,在治疗平均年龄为70±0.5岁的充血性心力衰竭(平均左心室射血分数为33.5±1%)老年患者中的疗效、安全性和耐受性。该研究按照双盲、平行组、随机多中心方案进行。在为期14天的安慰剂导入期后,患者被随机分为两组,分别每日口服一次5毫克赖诺普利或每日口服一次12.5毫克卡托普利。研究药物的剂量可每2周加倍一次,持续6周。最大剂量为每日一次20毫克赖诺普利或每日两次25毫克卡托普利。在利尿剂治疗方案中加用卡托普利或赖诺普利,在治疗12周后,通过自行车测力计评估的运动耐量显著增加(分别为530±21秒对431±13秒,p<0.01;555±19秒对463±l2秒,p<0.01)。两种药物均显著增加左心室射血分数和每搏输出量,在改善纽约心脏协会(NYHA)心功能分级方面同样有效,且耐受性良好,治疗之间未发现差异。本研究结果表明,每日一次5 - 20毫克赖诺普利在治疗老年充血性心力衰竭患者时,至少与每日12.5 - 50毫克卡托普利的疗效相当且耐受性良好。