Effect of rosuvastatin versus atorvastatin on new-onset diabetes mellitus in patients treated with high-intensity statin therapy for coronary artery disease: a post-hoc analysis from the LODESTAR randomized clinical trial.

IF 8.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Sung-Jin Hong, Yong-Joon Lee, Woong Chol Kang, Bum-Kee Hong, Jong-Young Lee, Jin-Bae Lee, Tae-Hyun Yang, Junghan Yoon, Seung-Jun Lee, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Myeong-Ki Hong
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Abstract

Background: The impact of rosuvastatin versus atorvastatin on new-onset diabetes mellitus (NODM) among patients treated with high-intensity statin therapy for coronary artery disease (CAD) remains to be clarified. This study aimed to evaluate the risk of NODM in patients with CAD treated with rosuvastatin compared to atorvastatin in the randomized LODESTAR trial.

Methods: In the LODESTAR trial, patients with CAD were randomly assigned to receive either rosuvastatin or atorvastatin using a 2-by-2 factorial randomization. In this post-hoc analysis, the 3-year incidence of NODM was compared between rosuvastatin and atorvastatin treatment in the as-treated population with high-intensity statin therapy as the principal population of interest.

Results: Among 2932 patients without diabetes mellitus at baseline, 2377 were included in the as-treated population analysis. In the as-treated population with high-intensity statin therapy, the incidence of NODM was not significantly different between the rosuvastatin and atorvastatin groups (11.4% [106/948] versus 8.8% [73/856], hazard ratio [HR] = 1.32, 95% confidence interval [CI] = 0.98 to 1.77, P = 0.071). When the risk of NODM with rosuvastatin versus atorvastatin was assessed according to the achieved low-density lipoprotein cholesterol (LDL-C) level, the risk of NODM began to increase at a LDL-C level below 70 mg/dL. The incidence of NODM was significantly greater in the rosuvastatin group than it was in the atorvastatin group when the achieved LDL-C level was < 70 mg/dL (13.9% versus 8.0%; HR = 1.79, 95% CI 1.18 to 2.73, P = 0.007).

Conclusions: Among CAD patients receiving high-intensity statin therapy, the incidence of NODM was not significantly different between rosuvastatin and atorvastatin. However, a drug effect of the statin type on NODM was observed when the achieved LDL-C level was < 70 mg/dL.

Trial registration: ClinicalTrials.gov, Identifier: NCT02579499.

罗伐他汀与阿托伐他汀对冠心病高强度他汀治疗患者新发糖尿病的影响:LODESTAR 随机临床试验的事后分析。
背景:罗伐他汀与阿托伐他汀相比对接受高强度他汀治疗的冠状动脉疾病(CAD)患者中新发糖尿病(NODM)的影响仍有待明确。本研究旨在评估在随机LODESTAR试验中,与阿托伐他汀相比,使用罗伐他汀治疗冠心病患者的新发糖尿病风险:在LODESTAR试验中,采用2乘2的因子随机法将CAD患者随机分配给罗伐他汀或阿托伐他汀。在这项事后分析中,以高强度他汀治疗为主要研究对象,比较了罗伐他汀和阿托伐他汀治疗3年的NODM发病率:在2932名基线时未患有糖尿病的患者中,有2377人被纳入治疗人群分析。在接受高强度他汀治疗的治疗人群中,罗伐他汀组和阿托伐他汀组的NODM发生率无显著差异(11.4% [106/948] 对 8.8% [73/856],危险比 [HR] = 1.32,95% 置信区间 [CI] = 0.98 至 1.77,P = 0.071)。根据所达到的低密度脂蛋白胆固醇(LDL-C)水平评估罗苏伐他汀与阿托伐他汀的NODM风险,当LDL-C水平低于70毫克/分升时,NODM风险开始增加。当LDL-C水平达到结论时,罗伐他汀组的NODM发生率明显高于阿托伐他汀组:在接受高强度他汀治疗的 CAD 患者中,罗伐他汀和阿托伐他汀的 NODM 发生率没有明显差异。然而,当达到的 LDL-C 水平为试验注册时,观察到他汀类药物对 NODM 有药物效应:试验注册:ClinicalTrials.gov,标识符:NCT02579499:NCT02579499。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Cardiovascular Diabetology
Cardiovascular Diabetology 医学-内分泌学与代谢
CiteScore
12.30
自引率
15.10%
发文量
240
审稿时长
1 months
期刊介绍: Cardiovascular Diabetology is a journal that welcomes manuscripts exploring various aspects of the relationship between diabetes, cardiovascular health, and the metabolic syndrome. We invite submissions related to clinical studies, genetic investigations, experimental research, pharmacological studies, epidemiological analyses, and molecular biology research in this field.
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