医学
瑞舒伐他汀
阿托伐他汀
危险系数
内科学
冠状动脉疾病
心肌梗塞
中止
随机对照试验
心脏病学
置信区间
外科
作者
Yong-Joon Lee,Sung Jin Hong,Woong Chol Kang,Bum–Kee Hong,Jong‐Young Lee,Jin-Bae Lee,Hyung-Jin Cho,Jung Han Yoon,Seungjun Lee,Chul‐Min Ahn,Jung Sun Kim,Byeong‐Keuk Kim,Young Guk Ko,Donghoon Choi,Yangsoo Jang,Myeong Ki Hong
标识
DOI:10.1136/bmj-2023-075837
摘要
Abstract 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% v 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 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 .
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