Abstract :
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, non-fatal 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.
