他汀类药物诱发糖尿病的风险并不会降低一级预防中的心血管获益：一项针对大量人群的6年倾向评分匹配研究。

Statin-induced risk of diabetes does not reduce cardiovascular benefits in primary prevention: a 6-year propensity-score matched study in a large population.

作者信息

Lembo Maria, Trimarco Valentina, Izzo Raffaele, Pacella Daniela, Jankauskas Stanislovas S, Gallo Paola, Piccinocchi Roberto, Morisco Carmine, Piccinocchi Gaetano, Bardi Luca, Cristiano Stefano, Esposito Giovanni, Giugliano Giuseppe, Varzideh Fahimeh, Manzi Maria Virginia, Trimarco Bruno, Santulli Gaetano

机构信息

Department of Advanced Biomedical Sciences, "Federico II" University, Naples, Italy.

Department of Neuroscience, Reproductive Sciences, and Dentistry, "Federico II" University, Naples, Italy.

出版信息

Cardiovasc Diabetol. 2025 May 31;24(1):233. doi: 10.1186/s12933-025-02798-2.

DOI:10.1186/s12933-025-02798-2

PMID:40450251

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12125874/

Abstract

BACKGROUND

The long-term risk of cardiovascular (CV) events in individuals who develop new-onset type 2 diabetes (T2D) after having received statin therapy in primary prevention is mostly unknown.

METHODS

We designed a population-based cohort study in individuals without T2D and atherosclerotic CV disease (ASCVD), divided in two groups according to the presence or not of statin therapy. We also balanced the study groups for demographic and clinical factors using propensity score matching.

RESULTS

119307 individuals without T2D and ASCVD were divided in statin users (N = 90906) or not (N = 28401) and followed-up for 70.1 ± 61.3 months. Yearly incidence of T2D rate was 0.3% in the control group and 2.2% in the statin treated group. A Cox regression analysis confirmed the association between incident T2D and statin therapy. In normotensive individuals, the presence of statin therapy led to a 2-fold risk to develop incident T2D with a HR 2.61 (95% CI 2.11-3.22, p < 0.001) which was also that of statin untreated hypertensive patients. In the hypertensive population statin therapy was associated with a HR of incident T2D of 4.62 (95% CI 3.75-5.69, p < 0.001). CV events rate, including coronary and cerebrovascular fatal and non-fatal events, was 1.9% in the statin group vs. 0.7% in the control group and a multiple regression analysis demonstrated an association between statin therapy and CV events. A further Cox regression performed only in the statin treated population revealed a significant association of CV events with age, serum creatinine levels, and incident T2D. Of note, the increased rate of new-onset T2D associated with statin use does not modify the class of CV risk of this population. All these findings were confirmed at the propensity score matched analysis.

CONCLUSIONS

Statin therapy in primary prevention is associated with a higher risk of incident T2D, especially in hypertensive patients. However, since the final CV risk of those who develop T2D during statin treatment was lower than the one required for statin prescription according to the ESC guidelines, indicating that this phenomenon does not impair the benefit in CV prevention associated with the lipid lowering effect of statins.

摘要

背景

在一级预防中接受他汀类药物治疗后新发2型糖尿病（T2D）的个体发生心血管（CV）事件的长期风险大多未知。

方法

我们针对无T2D和动脉粥样硬化性心血管疾病（ASCVD）的个体设计了一项基于人群的队列研究，根据是否接受他汀类药物治疗分为两组。我们还使用倾向评分匹配对研究组的人口统计学和临床因素进行了平衡。

结果

119307名无T2D和ASCVD的个体被分为他汀类药物使用者（N = 90906）和非使用者（N = 28401），并随访70.1±61.3个月。对照组T2D的年发病率为0.3%，他汀类药物治疗组为2.2%。Cox回归分析证实了新发T2D与他汀类药物治疗之间的关联。在血压正常的个体中，他汀类药物治疗会使发生新发T2D的风险增加两倍，风险比（HR）为2.61（95%置信区间[CI] 2.11 - 3.22，p < 0.001），他汀类药物未治疗的高血压患者也是如此。在高血压人群中，他汀类药物治疗与新发T2D的HR为4.62（95% CI 3.75 - 5.69，p < 0.001）。CV事件发生率，包括冠状动脉和脑血管的致命和非致命事件，他汀类药物组为1.9%，对照组为0.7%，多元回归分析表明他汀类药物治疗与CV事件之间存在关联。仅在他汀类药物治疗人群中进行的进一步Cox回归显示CV事件与年龄、血清肌酐水平和新发T2D之间存在显著关联。值得注意的是，与他汀类药物使用相关的新发T2D发生率增加并未改变该人群的CV风险类别。所有这些发现在倾向评分匹配分析中得到了证实。