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他汀类药物与糖尿病风险:来自大型基于人群队列研究的证据。

Statins and the risk of diabetes: evidence from a large population-based cohort study.

机构信息

Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy

Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.

出版信息

Diabetes Care. 2014 Aug;37(8):2225-32. doi: 10.2337/dc13-2215. Epub 2014 Jun 26.

Abstract

OBJECTIVE

To investigate the relationship between adherence with statin therapy and the risk of developing diabetes.

RESEARCH DESIGN AND METHODS

The cohort comprised 115,709 residents of the Italian Lombardy region who were newly treated with statins during 2003 and 2004. Patients were followed from the index prescription until 2010. During this period, patients who began therapy with an antidiabetic agent or were hospitalized for a main diagnosis of type 2 diabetes were identified (outcome). Adherence was measured by the proportion of days covered (PDC) with statins (exposure). A proportional hazards model was fitted to estimate hazard ratios (HRs) and 95% CIs for the exposure-outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty.

RESULTS

During follow-up, 11,154 cohort members experienced the outcome. Compared with patients with very-low adherence (PDC <25%), those with low (26-50%), intermediate (51-75%), and high (≥75%) adherence to statin therapy had HRs (95% CIs) of 1.12 (1.06-1.18), 1.22 (1.14-1.27), and 1.32 (1.26-1.39), respectively.

CONCLUSIONS

In a real-world setting, the risk of new-onset diabetes rises as adherence with statin therapy increases. Benefits of statins in reducing cardiovascular events clearly overwhelm the diabetes risk.

摘要

目的

研究他汀类药物治疗依从性与糖尿病发病风险之间的关系。

研究设计与方法

该队列纳入了 2003 年至 2004 年期间在意大利伦巴第地区新接受他汀类药物治疗的 115709 名居民。患者从索引处方开始随访至 2010 年。在此期间,确定了开始使用抗糖尿病药物或因 2 型糖尿病主要诊断住院的患者(结局)。通过他汀类药物的覆盖天数比例(PDC)来衡量依从性(暴露)。在调整了几个协变量后,采用比例风险模型来估计暴露-结局关联的风险比(HR)和 95%置信区间(CI)。进行了一系列敏感性分析,以考虑系统不确定性的来源。

结果

在随访期间,有 11154 名队列成员发生了结局事件。与低依从性(PDC<25%)的患者相比,低依从性(26-50%)、中依从性(51-75%)和高依从性(≥75%)的患者发生结局的 HR(95%CI)分别为 1.12(1.06-1.18)、1.22(1.14-1.27)和 1.32(1.26-1.39)。

结论

在真实环境中,随着他汀类药物治疗依从性的提高,新发糖尿病的风险会升高。他汀类药物降低心血管事件的获益显然超过了糖尿病风险。

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