瑞舒伐他汀与阿托伐他汀对接受高强度他汀类药物治疗冠心病患者新发糖尿病的影响：来自LODESTAR随机临床试验的事后分析
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.
作者信息
Hong Sung-Jin, Lee Yong-Joon, Kang Woong Chol, Hong Bum-Kee, Lee Jong-Young, Lee Jin-Bae, Yang Tae-Hyun, Yoon Junghan, Lee Seung-Jun, Ahn Chul-Min, Kim Jung-Sun, Kim Byeong-Keuk, Ko Young-Guk, Choi Donghoon, Jang Yangsoo, Hong Myeong-Ki
机构信息
Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Gachon University College of Medicine, Incheon, Korea.
出版信息
Cardiovasc Diabetol. 2024 Aug 7;23(1):287. doi: 10.1186/s12933-024-02386-w.
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.
背景
对于接受高强度他汀类药物治疗的冠心病（CAD）患者，瑞舒伐他汀与阿托伐他汀对新发糖尿病（NODM）的影响仍有待阐明。本研究旨在评估在随机化的LODESTAR试验中，与阿托伐他汀相比，接受瑞舒伐他汀治疗的CAD患者发生NODM的风险。
方法
在LODESTAR试验中，采用2×2析因随机化方法将CAD患者随机分配接受瑞舒伐他汀或阿托伐他汀治疗。在这项事后分析中，以接受高强度他汀类药物治疗的实际治疗人群作为主要研究对象，比较瑞舒伐他汀和阿托伐他汀治疗组之间NODM的3年发病率。
结果
在基线时无糖尿病的2932例患者中，2377例纳入实际治疗人群分析。在接受高强度他汀类药物治疗的实际治疗人群中，瑞舒伐他汀组和阿托伐他汀组之间NODM的发病率无显著差异（11.4%[106/948]对8.8%[73/856]，风险比[HR]=1.32，95%置信区间[CI]=0.98至1.77，P=0.071）。当根据达到的低密度脂蛋白胆固醇（LDL-C）水平评估瑞舒伐他汀与阿托伐他汀导致NODM的风险时，LDL-C水平低于70mg/dL时NODM风险开始增加。当达到的LDL-C水平<70mg/dL时，瑞舒伐他汀组NODM的发病率显著高于阿托伐他汀组（13.9%对8.0%；HR=1.79，95%CI 1.18至2.73，P=0.007）。
结论
在接受高强度他汀类药物治疗的CAD患者中，瑞舒伐他汀和阿托伐他汀之间NODM的发病率无显著差异。然而，当达到的LDL-C水平<70mg/dL时，观察到他汀类药物类型对NODM有药物效应。
试验注册
ClinicalTrials.gov，标识符：NCT02579499。
Zotero 插件