近日，韩国延世大学医学院Myeong-Ki Hong团队比较了瑞舒伐他汀与阿托伐他汀治疗成人冠状动脉疾病的长期疗效和安全性。2023年10月18日，《英国医学杂志》发表了这一成果。

为了比较瑞舒伐他汀与阿托伐他汀治疗成人冠状动脉疾病的长期疗效和安全性，2016年9月至2019年11月，研究组在韩国的12家医院进行了一项随机、开放标签、多中心试验。共招募4400名患有冠状动脉疾病的成年人（年龄≥19岁），将其随机分配，分别接受瑞舒伐他汀（n=2204）或阿托伐他汀（n=2196），采用2×2析因随机化。

主要结局是三年的全因死亡、心肌梗死、中风或任何冠状动脉血运重建的综合结局。次要结局是安全性终点：新发糖尿病；因心力衰竭入院；深静脉血栓形成或肺血栓栓塞；血管内血运重建治疗外周动脉疾病；主动脉介入或手术；终末期肾病；因不耐受而停用研究药物；白内障手术；以及实验室检测到的异常的组合。

4400名参与者中有4341人（98.7%）完成了试验。瑞舒伐他汀组研究药物的平均日剂量为17.1 mg（标准差（SD）5.2 mg），阿托伐他汀组为36.0（12.8）mg（P<0.001）。瑞舒伐他汀组189名参与者（8.7%）和阿托伐他汀组178名参与者（8.2%）发生主要结局（危险比为1.06；P=0.58）。

治疗期间，瑞舒伐他汀组的平均低密度脂蛋白（LDL）胆固醇水平为1.8 mmol/L（SD 0.5 mmol/L），阿托伐他汀组为1.9（0.5）mmol/L（P<0.001）。瑞舒伐他汀组需要开始服用抗糖尿病药物的新发糖尿病（7.2%v5.3%；危险比为1.39；P=0.03）和白内障手术（2.5%v1.5%；1.66；P=0.02）发生率较高。其他安全终点在两组之间没有差异。

研究结果表明，在患有冠状动脉疾病的成年人中，瑞舒伐他汀和阿托伐他汀在三年时对全因死亡、心肌梗死、中风或任何冠状动脉血运重建的综合结局中显示出相当的疗效。与阿托伐他汀相比，瑞舒伐他汀与低密度脂蛋白胆固醇水平较低有关，但需要抗糖尿病的新发糖尿病和白内障手术风险较高。

附：英文原文

Title: Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial

Author: Yong-Joon Lee, Sung-Jin Hong, Woong Chol Kang, Bum-Kee Hong, Jong-Young Lee, Jin-Bae Lee, Hyung-Jin Cho, Junghan Yoon, Seung-Jun Lee, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Myeong-Ki Hong

Issue&Volume: 2023/10/18

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.

DOI: 10.1136/bmj-2023-075837

Source: https://www.bmj.com/content/383/bmj-2023-075837