SHIFT研究及BEAUTIFUL研究原文及部分相關文献.docVIP

在稳定型冠心病伴左室收缩功能障碍的患者中应用伊伐布雷定（BEAUTIFUL）：一项随机、双盲、安慰剂对照试验 Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial Kim Fox, Ian Ford, P Gabriel Steg, Michal Tendera, Roberto Ferrari, on behalf of the BEAUTIFUL Investigators*? 2009/5/7 15:22:00? 柳叶刀中文版, 2009, Volume?3, Issue?1? ? ? BackgroundIvabradine specifically inhibits the If current in the sinoatrial node to lower heart rate, without affecting other aspects of cardiac function. We aimed to test whether lowering the heart rate with ivabradine reduces cardiovascular death and morbidity in patients with coronary artery disease and left-ventricular systolic dysfunction. Methods Between December, 2004, and December, 2006, we screened 12?473 patients at 781 centres in 33 countries. We enrolled 10?917 eligible patients who had coronary artery disease and a left-ventricular ejection fraction of less than 40% in a randomised, double-blind, placebo-controlled, parallel-group trial. 5479 patients received 5 mg ivabradine, with the intention of increasing to the target dose of 7·5 mg twice a day, and 5438 received matched placebo in addition to appropriate cardiovascular medication. The primary endpoint was a composite of cardiovascular death, admission to hospital for acute myocardial infarction, and admission to hospital for new onset or worsening heart failure. We analysed patients by intention to treat. The study is registered with ClinicalTrials.gov, number NC Findings Mean heart rate at baseline was 71·6 (SD 9·9) beats per minute (bpm). Median follow-up was 19 months (IQR 16–24). Ivabradine reduced heart rate by 6 bpm (SE 0·2) at 12 months, corrected for placebo. Most (87%) patients were receiving β blockers in addition to study drugs, and no safety concerns were identified. Ivabradine did not affect the primary composite endpoint (hazard ratio 1·00, 95% CI 0·91–1·1, p=0·94). 1233 (