Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial - the Losartan Heart Failure Survival Study ELITE II
Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial - the Losartan Heart Failure Survival Study ELITE II
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DOI：
10.1016/s0140-6736(00)02213-3
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发表时间：
2000-05-06
期刊：
影响因子：
168.9
通讯作者：
Thiyagarajan, B
中科院分区：
文献类型：
--
作者：
Pitt, B;Poole-Wilson, PA;Thiyagarajan, B
背景：精英研究表明，与血管紧张素转换酶(ACE)抑制剂卡托普利相比，血管紧张素II拮抗剂氯沙坦与老年心力衰竭患者意想不到的生存益处之间存在关联。我们进行了ELITE II Losartan心力衰竭生存研究，以确认氯沙坦在改善存活率和耐受性方面是否优于卡托普利。方法我们进行了一项双盲、随机、对照试验，研究对象为3152名年龄在60岁或以上、心力衰竭分级II-IV、射血分数小于或等于40%的患者。根据β-受体阻滞剂的使用情况，将患者随机分为两组：氯沙坦(n=1578)每日1次，或卡托普利(n=1574)每日3次，滴定至50 mg。主要终点和次要终点分别为全因死亡、猝死或复苏骤停。我们评估了安全性和耐受性。根据治疗意向进行分析。结果显示，中位随访时间为555天。两组全因死亡率(11.7%vs10.4%)、猝死或复苏后被捕(9.0%vs7.3%)无显著差异(危险比1.13[95.7%可信区间0.95~1.35]，p=0.16和1.5[95%可信区间0.98~1.60]，p=0.08)。氯沙坦组(不包括死亡患者)因不良反应而中断研究治疗的患者显著减少(9.7%比14.7%，p
Background The ELITE study showed an association between the angiotensin II antagonist losartan and an unexpected survival benefit in elderly heart-failure patients, compared with captopril, an angiotensin-converting-enzyme (ACE) inhibitor. We did the ELITE II Losartan Heart Failure Survival Study to confirm whether losartan is superior to captopril in improving survival and is better tolerated.Methods We undertook a double-blind, randomised, controlled trial of 3152 patients aged 60 years or older with New York Heart Association class II-IV heart failure and ejection fraction of 40% or less. Patients, stratified for beta-blocker use, were randomly assigned losartan (n=1578) titrated to 50 mg once daily or captopril (n=1574) titrated to 50 mg three times daily. The primary and secondary endpoints were all-cause mortality, and sudden death or resuscitated arrest. We assessed safety and tolerability. Analysis was by intention to treat.Findings Median follow-up was 555 days. There were no significant differences in all-cause mortality (11.7 vs 10.4% average annual mortality rate) or sudden death or resuscitated arrests (9.0 vs 7.3%) between the two treatment groups (hazard ratios 1.13 [95.7% CI 0.95-1.35], p=0.16and 1.5 [95% CI 0.98-1.60], p=0.08). Significantly fewer patients in the losartan group (excluding those who died) discontinued study treatment because of adverse effects (9.7 vs 14.7%, p