Effect of verapamil on mortality and major events after acute myocardial infarction (the Danish Verapamil Infarction Trial II--DAVIT II)

Effect of verapamil on mortality and major events after acute myocardial infarction (the Danish Verapamil Infarction Trial II--DAVIT II)
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DOI:
10.1016/0002-9149(90)90351-z
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发表时间:
1990
期刊:
The American journal of cardiology
影响因子:
--
通讯作者:
J. Hansen
J. Hansen
中科院分区:
其他
文献类型:
--
作者:
J. Hansen

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在一项双盲、随机、安慰剂对照的多中心试验中,研究了维拉帕米对急性心肌梗死后死亡和重大事件(即死亡或再梗塞)的影响。878名患者开始服用维拉帕米,每天360毫克,897名患者服用安慰剂。治疗在入院后第二周开始,最长持续18个月(平均16个月)。维拉帕米组发生95例死亡和146例重大事件,安慰剂组发生119例死亡和180例重大事件。维拉帕米组和安慰剂组的18个月死亡率分别为11.1%和13.8%(p=0.11,危险比为0.80;95%可信区间为0.61~1.05),重大事件发生率分别为18.0%和21.6%(p=0.03,危险比为0.80;95%可信区间为0.64~0.99)。在冠状动脉护理病房中无心力衰竭的患者中,维拉帕米组和安慰剂组的死亡率分别为7.7%和11.8%(p=0.02,危险比0.64;95%可信区间0.44至0.94),重大事件发生率14.6%和19.7%(p=0.01,危险比0.70;95%可信区间0.52至0.93)。心力衰竭患者的死亡率分别为17.9%和17.5%(P=0.79,危险比1.05;95%可信区间0.72~1.54),重大事件发生率24.9%和24.9%(P=1.0,危险比0.98;95%可信区间0.72~1.39)。急性心肌梗死后长期服用维拉帕米可显著减少重大事件的发生,且对无心衰的患者有积极作用。
The effect of verapamil on death and major events (i.e., death or reinfarction) after an acute myocardial infarction was studied in a double-blind, randomized, placebo-controlled multicenter trial. Eight hundred seventy-eight patients started treatment with verapamil, 360 mg/day, and 897 patients with placebo. Treatment started in the second week after admission and continued for up to 18 months (mean 16 months). Ninety-five deaths and 146 major events occurred in the verapamil group and 119 deaths and 180 major events in the placebo group. The 18-month mortality rates were 11.1 and 13.8% (p = 0.11, hazard ratio, 0.80; 95% confidence limits, 0.61 to 1.05), and major event rates 18.0 and 21.6% (p = 0.03, hazard ratio, 0.80; 95% confidence limits, 0.64 to 0.99) in the verapamil and placebo groups, respectively. In patients without heart failure in the coronary care unit the mortality rates were 7.7% in the verapamil group and 11.8% in the placebo group (p = 0.02, hazard ratio, 0.64; 95% confidence limits, 0.44 to 0.94), and major event rates 14.6 and 19.7% (p = 0.01, hazard ratio 0.70; 95% confidence limits (0.52 to 0.93). In patients with heart failure the mortality rates were 17.9 and 17.5% (p = 0.79, hazard ratio, 1.05; 95% confidence limits, 0.72 to 1.54), and major event rates 24.9 and 24.9% (p = 1.0, hazard ratio 0.98; 95% confidence limits 0.72 to 1.39).Long-term treatment with verapamil after an acute myocardial infarction caused a significant reduction in major events, and the positive effect was found in patients without heart failure.