Fosinopril attenuates clinical deterioration and improves exercise tolerance in patients with heart failure
Fosinopril attenuates clinical deterioration and improves exercise tolerance in patients with heart failure
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DOI：
10.1093/oxfordjournals.eurheartj.a060844
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发表时间：
1995-12-01
影响因子：
39.3
通讯作者：
Gelperin, K
中科院分区：
文献类型：
--
作者：
Erhardt, L;MacLean, A;Gelperin, K
本研究是一项为期12周、双盲、安慰剂对照、福辛普利多国试验，在308例轻度至中重度心力衰竭患者中进行（纽约心脏协会[NYHA]心功能分级IIS 17%、IIM 48%和III 35%;平均射血功能[+/-SD] 26. 5%[+/-6. 9%];自行车运动持续时间1至11分钟）。初始剂量为10 mg每日一次，根据耐受性调整至40 mg每日一次。所有患者均接受利尿剂治疗;地高辛是可选的。主要终点是最大自行车运动时间;次要终点是发生以下前瞻性定义的、指示心力衰竭恶化的有序临床事件：死亡、研究中止、住院、急诊室就诊和需要补充利尿剂。（每例其他患者获得的最后一个值），福辛普利组自行车运动时间（38.1 s）比安慰剂组（23.5 s）增加更多（ANCOVA分析P=0.101，前瞻性定义的脱落校正终点分析P= 0.010）。福辛普利治疗组（89%）比安慰剂组（75%）更多患者未发生提示心力衰竭恶化的临床事件，福辛普利治疗组患者的最严重事件往往比安慰剂组患者的严重程度低（P=0.001）。对个体临床事件发生率的分析表明，福辛普利组对补充利尿剂的需求显著减少（8% vs 20%的患者，P=0.002），住院率（3% vs 12%的患者，P=0.002）和研究中止率（2% vs 12%的患者，P =0.002）也显著减少。
This study was a 12-week, double-blind, placebo-controlled, multinational trial of fosinopril in 308 patients with mild to moderately severe heart failure (New York Heart Association [NYHA] functional class IIS 17%, IIM 48%, and III 35%; mean ejection function [+/-SD] 26.5% [+/-6.9%]; bicycle exercise duration 1 to 11 min). An initial dose of 10 mg once daily was titrated as tolerated to 40 mg once daily. Patients all received diuretic therapy; digoxin was optional. The primary endpoint was maximal bicycle exercise time; a secondary endpoint was occurrence of the following prospectively defined, ordered clinical events indicative of worsening heart failure: death, study discontinuation, hospitalization, emergency room visits and need for supplemental diuretic.At study endpoint (last value obtained for each other patient), bicycle exercise time increased more with fosinopril (38.1 s) than with placebo (23.5 s) (P=0.101 by ANCOVA and 0.010 by prospectively defined dropout-adjusted endpoint analysis). More patients remained free of clinical events indicative of worsening heart failure when treated with fosinopril (89%) than with placebo (75%), and the worst events of fosinopril-treated patients tended to be less severe than those of placebo patients (P=0.001). Analysis of the occurrence of individual clinical events showed that the need for supplemental diuretic was markedly reduced with fosinopril (8% vs 20% of patients, P=0.002), as were hospitalizations (3% vs 12% of patients, P=0.002) and study discontinuations (2% vs 12% of patients, p