Packer M, O'Connor C M, Ghali J K, Pressler M L, Carson P E, Belkin R N, Miller A B, Neuberg G W, Frid D, Wertheimer J H, Cropp A B, DeMets D L
College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
N Engl J Med. 1996 Oct 10;335(15):1107-14. doi: 10.1056/NEJM199610103351504.
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.
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.
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<0.001).
Amlodipine did not increase cardiovascular morbidity or mortality in patients with severe heart failure. The possibility that amlodipine prolongs survival in patients with nonischemic dilated cardiomyopathy requires further study.
既往研究表明，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。我们研究了一种新型钙通道阻滞剂氨氯地平对重度慢性心力衰竭患者的影响。
我们将1153例重度慢性心力衰竭且射血分数低于30%的患者随机分为两组，分别接受安慰剂（582例患者）或氨氯地平（571例患者）双盲治疗6至33个月，同时继续其常规治疗。随机分组根据患者心力衰竭的病因是缺血性还是非缺血性进行分层。该研究的主要终点是任何原因导致的死亡以及因重大心血管事件住院。
安慰剂组42%的患者达到主要终点，氨氯地平组为39%，这表明氨氯地平使致命和非致命事件的联合风险降低了9%（95%置信区间，降低24%至增加10%；P = 0.31）。安慰剂组共有38%的患者死亡，氨氯地平组为33%，这表明氨氯地平使死亡风险降低了16%（95%置信区间，降低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一个终点事件的发生率上没有差异。相比之下，在非缺血性心肌病患者中，氨氯地平使致命和非致命事件的联合风险降低了31%（P = 0.04），并使死亡风险降低了46%（P < 0.001）。
氨氯地平不会增加重度心力衰竭患者的心血管发病率或死亡率。氨氯地平可延长非缺血性扩张型心肌病患者生存期的可能性需要进一步研究。
