Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial
Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial
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DOI：
10.1016/s0140-6736(02)08265-x
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发表时间：
2002-04-13
期刊：
影响因子：
168.9
通讯作者：
Hillis, WS
中科院分区：
文献类型：
--
作者：
Dargie, HJ;Ford, I;Hillis, WS
除其抗缺血作用外，抗心绞痛药物尼可地尔被认为具有心脏保护作用。我们进行了一项随机试验，以确定尼可地尔是否可以降低患有稳定性心绞痛和其他危险因素的男性和女性冠状动脉事件的频率。方法5126例患者在标准抗心绞痛治疗的基础上，随机给予20 mg尼可地尔，每日2次（n=2565）或相同安慰剂（n=2561）。主要复合终点为冠心病死亡、非致死性心肌梗死或因心源性胸痛而意外住院。次要终点是冠心病死亡或非致死性心肌梗死的综合结局。报告的其他结局包括全因死亡率、所有心血管事件和急性冠状动脉综合征。平均随访1.6年（SD 0.5）。分析的目的是治疗。安慰剂组有398例（15.5%）主要终点事件，尼可地尔组有337例（13.1%）（风险比0.83,95% Cl 0.72-0.97; p=0.014）。次要终点发生的频率在两组间无显著差异（134例事件[5.2%]vs 107例事件[4.2%];0.79,0.61-1.02;p=0.068）。安慰剂组和尼可地尔组急性冠脉综合征发生率分别为195例（7.6%）和156例（6.1%）（0.79,0.64-0.98,p=0.028），所有心血管事件发生率分别为436例（17.0%）和378例（14.7%）（0.86,0.75-0.98,p=0.027）。研究结果表明，稳定型心绞痛患者使用尼可地尔抗心绞痛治疗可显著降低主要冠状动脉事件的发生率。
Background In addition to its anti-ischaemic effects, the antianginal drug nicorandil is thought to have cardioprotective properties. We did a randomised trial to find out whether nicorandil could reduce the frequency of coronary events in men and women with stable angina and additional risk factors.Methods 5126 patients were randomly assigned 20 mg nicorandil twice daily (n=2565) or identical placebo (n=2561) in addition to standard antianginal therapy. The primary composite endpoint was coronary heart disease death, nonfatal myocardial infarction, or unplanned hospital admission for cardiac chest pain. The secondary endpoint was the combined outcome of coronary heart disease death or nonfatal myocardial infarction. Other outcomes reported include all-cause mortality, all cardiovascular events, and acute coronary syndromes. Mean follow-up was 1.6 years (SD 0.5). Analysis was by intention to treat.Findings There were 398 (15.5%) primary endpoint events in the placebo group and 337 (13.1%) in the nicorandil group (hazard ratio 0.83, 95% Cl 0.72-0.97; p=0.014). The frequency of the secondary endpoint was not significantly different between the groups (134 events [5.2%] vs 107 events [4.2%]; 0.79, 0.61-1.02; p=0.068). The rate of acute coronary syndromes was 195 (7.6%) in the placebo group and 156 (6.1%) in the nicorandil group (0.79, 0.64-0.98; p=0.028), and the corresponding rates for all cardiovascular events were 436 (17.0%) and 378 (14.7%; 0.86, 0.75-0.98; p=0.027).Interpretation We showed a significant improvement in outcome due to a reduction in major coronary events by antianginal therapy with nicorandil in patients with stable angina.