Effect of amlodipine on morbidity and mortality in severe chronic heart failure
Effect of amlodipine on morbidity and mortality in severe chronic heart failure
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DOI：
10.1056/nejm199610103351504
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发表时间：
1996-10-10
影响因子：
158.5
通讯作者：
DeMets, DL
中科院分区：
文献类型：
--
作者：
Packer, M;OConnor, CM;DeMets, DL
先前的研究表明，钙通道阻滞剂会增加慢性心力衰竭患者的发病率和死亡率。我们研究了一种新的钙通道阻滞剂氨氯地平在严重慢性心力衰竭患者中的作用。方法：我们随机分配1153例严重慢性心力衰竭且射血分数小于30%的患者接受安慰剂（582例）或氨氯地平（571例）双盲治疗6 - 33个月，同时继续常规治疗。随机分组是根据患者是否有缺血性或非缺血性心力衰竭原因进行分层。该研究的主要终点是因任何原因死亡和因主要心血管事件住院。结果安慰剂组和氨氯地平组分别有42%和39%的患者达到了主要终点，表明氨氯地平组致死性和非致死性事件的综合风险降低了9%（95%置信区间，降低24%至增加10%；P=0.31）。安慰剂组中有38%的患者死亡，而氨氯地平组中有33%的患者死亡，这表明氨氯地平组的死亡风险降低了16%（95%置信区间，减少31%至增加2%；P=0.07）。在缺血性心脏病患者中，氨氯地平组和安慰剂组在任何终点的发生率均无差异。相比之下，在非缺血性心肌病患者中，氨氯地平将致死性和非致死性事件的总风险降低了31% (P=0.04)，将死亡风险降低了46% （P=0.04）
Background Previous studies have shown that calcium-channel blockers increase morbidity and mortality in patients with chronic heart failure. We studied the effect of a new calcium-channel blocker, amlodipine, in patients with severe chronic heart failure.Methods We randomly assigned 1153 patients with severe chronic heart failure and ejection fractions of less than 30 percent to double-blind treatment with either placebo (582 patients) or amlodipine (571 patients) for 6 to 33 months, while their usual therapy was continued. The randomization was stratified on the basis of whether patients had ischemic or nonischemic causes of heart failure. The primary end point of the study was death from any cause and hospitalization for major cardiovascular events.Results Primary end points were reached in 42 percent of the placebo group and 39 percent of the amlodipine group, representing a 9 percent reduction in the combined risk of fatal and nonfatal events with amlodipine (95 percent confidence interval, 24 percent reduction to 10 percent increase; P=0.31). A total of 38 percent of the patients in the placebo group died, as compared with 33 percent of those in the amlodipine group, representing a 16 percent reduction in the risk of death with amlodipine (95 percent confidence interval, 31 percent reduction to 2 percent increase; P=0.07). Among patients with ischemic heart disease, there was no difference between the amlodipine and placebo groups in the occurrence of either end point. In contrast, among patients with nonischemic cardiomyopathy, amlodipine reduced the combined risk of fatal and nonfatal events by 31 percent (P=0.04) and decreased the risk of death by 46 percent (P