Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seodaemun-gu, 03722, Seoul, Korea.
Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seodaemun-gu, 03722, Seoul, Korea
BMJ. 2023 Oct 18;383:e075837. doi: 10.1136/bmj-2023-075837.
OBJECTIVE: To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease. DESIGN: Randomised, open label, multicentre trial. SETTING: 12 hospitals in South Korea, September 2016 to November 2019. PARTICIPANTS: 4400 adults (age ≥19 years) with coronary artery disease. INTERVENTIONS: Participants were assigned to receive either rosuvastatin (n=2204) or atorvastatin (n=2196) using 2×2 factorial randomisation. MAIN OUTCOME MEASURES: The primary outcome was a three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation. Secondary outcomes were safety endpoints: new onset diabetes mellitus; hospital admissions due to heart failure; deep vein thrombosis or pulmonary thromboembolism; endovascular revascularisation for peripheral artery disease; aortic intervention or surgery; end stage kidney disease; discontinuation of study drugs owing to intolerance; cataract surgery; and a composite of laboratory detected abnormalities. RESULTS: 4341 of the 4400 participants (98.7%) completed the trial. Mean daily dose of study drugs was 17.1 mg (standard deviation (SD) 5.2 mg) in the rosuvastatin group and 36.0 (12.8) mg in the atorvastatin group at three years (P<0.001). The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58). The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001). The rosuvastatin group had a higher incidence of new onset diabetes mellitus requiring initiation of antidiabetics (7.2% 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between the two groups. CONCLUSIONS: In adults with coronary artery disease, rosuvastatin and atorvastatin showed comparable efficacy for the composite outcome of all cause death, myocardial infarction, stroke, or any coronary revascularisation at three years. Rosuvastatin was associated with lower LDL cholesterol levels but a higher risk of new onset diabetes mellitus requiring antidiabetics and cataract surgery compared with atorvastatin. TRIAL REGISTRATION: ClinicalTrials.gov NCT02579499.
目的：比较瑞舒伐他汀与阿托伐他汀治疗成人冠心病的长期疗效和安全性。
设计：随机、开放标签、多中心试验。
地点：韩国 12 家医院，2016 年 9 月至 2019 年 11 月。
参与者：4400 名年龄≥19 岁的冠心病成人。
干预措施：参与者采用 2×2 析因随机分配，分别接受瑞舒伐他汀（n=2204）或阿托伐他汀（n=2196）治疗。
主要结局指标：主要结局为全因死亡、心肌梗死、卒中和任何冠状动脉血运重建的 3 年复合结局。次要结局为安全性终点：新发糖尿病；因心力衰竭住院；深静脉血栓形成或肺血栓栓塞症；外周动脉疾病的血管内血运重建；主动脉介入或手术；终末期肾病；因不耐受而停止研究药物；白内障手术；以及实验室检测异常的复合终点。
结果：4400 名参与者中的 4341 名（98.7%）完成了试验。瑞舒伐他汀组的平均日剂量为 17.1mg（标准差 5.2mg），阿托伐他汀组为 36.0（12.8）mg，持续 3 年（P<0.001）。瑞舒伐他汀组 189 名（8.7%）参与者和阿托伐他汀组 178 名（8.2%）参与者发生主要结局（风险比 1.06，95%置信区间 0.86 至 1.30；P=0.58）。瑞舒伐他汀组治疗期间的平均低密度脂蛋白胆固醇水平为 1.8mmol/L（标准差 0.5mmol/L），阿托伐他汀组为 1.9（0.5）mmol/L（P<0.001）。瑞舒伐他汀组新发糖尿病需要起始用降糖药的发生率更高（7.2% 5.3%；风险比 1.39，95%置信区间 1.03 至 1.87；P=0.03）和白内障手术（2.5% 1.5%；1.66，1.07 至 2.58；P=0.02）。两组其他安全性终点无差异。
结论：在冠心病成人中，瑞舒伐他汀和阿托伐他汀在 3 年时全因死亡、心肌梗死、卒中和任何冠状动脉血运重建的复合结局方面疗效相当。与阿托伐他汀相比，瑞舒伐他汀可降低 LDL 胆固醇水平，但新发糖尿病需要用降糖药治疗和白内障手术的风险更高。
临床试验注册：ClinicalTrials.gov NCT02579499。
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