Division of Cardiology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
Biostatistical Consultation Center of Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
Sci Rep. 2021 Mar 23;11(1):6697. doi: 10.1038/s41598-021-86090-9.
Atorvastatin 40 mg (ATOR 40) and ezetimibe 10 mg/simvastatin 20 mg (EZ-SIM 20) have similar reductions of low-density lipoprotein cholesterol (LDL-C) but cardiovascular (CV) outcomes between these two therapies are unclear. Our real-world cohort study is to test the hypothesis of pleiotropic effects of purely higher dose statin on CV outcomes beyond similar reductions of LDL-C, especially for extremely CV risk patients. Between January 1, 2007 and December 31, 2013, a total of 3,372 patients with type 2 diabetes mellitus (T2DM) admitted due to acute coronary syndrome (ACS) or acute ischemic stroke (AIS) were selected as the study cohort from the Taiwan National Health Insurance Research Database. Clinical outcomes were evaluated by ATOR 40 group (n = 1686) matched with EZ-SIM 20 group (n = 1686). Primary composite outcome includes CV death, non-fatal myocardial infarction, and non-fatal stroke. Secondary composite outcome includes hospitalization for unstable angina (HUA), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). With a mean follow-up of 2.4 years, no significant difference of primary composite outcome was observed between ATOR 40 and EZ-SIM 20 groups (subdistribution hazard ratio [SHR], 1.09; 95% confidence interval [CI], 0.95-1.25). Nevertheless, ATOR 40 group had lower risks of HUA (SHR, 0.50; 95% CI, 0.35-0.72), PCI (SHR, 0.82; 95% CI, 0.69-0.97) and CABG (SHR, 0.62; 95% CI, 0.40-0.97) than EZ-SIM 20 group. For T2DM patients after ACS or AIS, ATOR 40 and EZ-SIM 20 had similar major CV outcomes, which still supported the main driver for CV risk reductions is LDL-C lowering.
阿托伐他汀 40 毫克（ATOR 40）和依折麦布 10 毫克/辛伐他汀 20 毫克（EZ-SIM 20）降低低密度脂蛋白胆固醇（LDL-C）的效果相似，但这两种治疗方法的心血管（CV）结局尚不清楚。我们的真实世界队列研究旨在检验这样一种假设，即单纯较高剂量他汀类药物除了降低 LDL-C 之外，对 CV 结局还有多效作用，特别是对于极高 CV 风险的患者。2007 年 1 月 1 日至 2013 年 12 月 31 日，从台湾全民健康保险研究数据库中选择了 3372 例因急性冠状动脉综合征（ACS）或急性缺血性脑卒中（AIS）住院的 2 型糖尿病（T2DM）患者作为研究队列。通过 ATOR 40 组（n=1686）与 EZ-SIM 20 组（n=1686）进行匹配，评估临床结局。主要复合结局包括心血管死亡、非致死性心肌梗死和非致死性脑卒中。次要复合结局包括不稳定型心绞痛（HUA）住院、经皮冠状动脉介入治疗（PCI）和冠状动脉旁路移植术（CABG）。平均随访 2.4 年后，ATOR 40 组与 EZ-SIM 20 组主要复合结局无显著差异（亚分布风险比[SHR]，1.09；95%置信区间[CI]，0.95-1.25）。然而，ATOR 40 组发生 HUA（SHR，0.50；95%CI，0.35-0.72）、PCI（SHR，0.82；95%CI，0.69-0.97）和 CABG（SHR，0.62；95%CI，0.40-0.97）的风险均低于 EZ-SIM 20 组。对于 ACS 或 AIS 后的 T2DM 患者，ATOR 40 和 EZ-SIM 20 的主要 CV 结局相似，这仍然支持降低 LDL-C 是 CV 风险降低的主要驱动因素。
