Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors:: the CHARM-Alternative trial
Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors:: the CHARM-Alternative trial
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DOI：
10.1016/s0140-6736(03)14284-5
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发表时间：
2003-09-06
期刊：
影响因子：
168.9
通讯作者：
Swedberg, K
中科院分区：
文献类型：
--
作者：
Granger, CB;McMurray, JJV;Swedberg, K
背景 血管紧张素转换酶 (ACE) 抑制剂可改善慢性心力衰竭 (CHF) 患者的预后。然而，相当一部分患者由于先前的不耐受而没有从 ACE 抑制剂中获益。我们的目的是查明坎地沙坦（一种血管紧张素受体阻滞剂）是否可以改善不服用 ACE 抑制剂的患者的预后。 方法 1999 年 3 月至 2001 年 3 月期间，我们招募了 2028 名有症状的心力衰竭且左心室射血分数为 40% 或更低的患者，这些患者因既往不耐受而未接受 ACE 抑制剂治疗。患者被随机分配坎地沙坦（目标剂量 32 mg，每日一次）或匹配的安慰剂。该研究的主要结果是心血管死亡或因CHF入院的复合结果。按意向治疗进行分析。结果 ACE 抑制剂不耐受的最常见表现是咳嗽（72%），其次是症状性低血压（13%）和肾功能不全（12%）。在中位随访时间为 33.7 个月期间，坎地沙坦组 1013 名患者中有 334 名患者 (33%) 和安慰剂组 1015 名患者中有 406 名患者 (40%) 发生心血管死亡或因 CHF 入院（未经调整的风险比 0.77 [95% CI 0.67-0.89]，p=0.0004；协变量调整 0.70 [0.60-0.81]，p
Background Angiotensin-converting-enzyme (ACE) inhibitors improve outcome of patients with chronic heart failure (CHF). A substantial proportion of patients, however, experience no benefit from ACE inhibitors because of previous intolerance. We aimed to find out whether candesartan, an angiotensin-receptor blocker, could improve outcome in such patients not taking an ACE inhibitor.Methods Between March, 1999, and March, 2001, we enrolled 2028 patients with symptomatic heart failure and left-ventricular ejection fraction 40% or less who were not receiving ACE inhibitors because of previous intolerance. Patients were randomly assigned candesartan (target dose 32 mg once daily) or matching placebo. The primary outcome of the study was the composite of cardiovascular death or hospital admission for CHF. Analysis was by intention to treat.Findings The most common manifestation of ACE-inhibitor intolerance was cough (72%), followed by symptomatic hypotension (13%) and renal dysfunction (12%). During a median follow-up of 33.7 months, 334 (33%) of 1013 patients in the candesartan group and 406 (40%) of 1015 in the placebo group had cardiovascular death or hospital admission for CHF (unadjusted hazard ratio 0.77 [95% CI 0.67-0.89], p=0.0004; covariate adjusted 0.70 [0.60-0.81], p