BHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Pl, Glasgow G12 8TA, Scotland, United Kingdom.
JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
CONTEXT: A recent meta-analysis demonstrated that statin therapy is associated with excess risk of developing diabetes mellitus. OBJECTIVE: To investigate whether intensive-dose statin therapy is associated with increased risk of new-onset diabetes compared with moderate-dose statin therapy. DATA SOURCES: We identified relevant trials in a literature search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (January 1, 1996, through March 31, 2011). Unpublished data were obtained from investigators. STUDY SELECTION: We included randomized controlled end-point trials that compared intensive-dose statin therapy with moderate-dose statin therapy and included more than 1000 participants who were followed up for more than 1 year. DATA EXTRACTION: Tabular data provided for each trial described baseline characteristics and numbers of participants developing diabetes and experiencing major cardiovascular events (cardiovascular death, nonfatal myocardial infarction or stroke, coronary revascularization). We calculated trial-specific odds ratios (ORs) for new-onset diabetes and major cardiovascular events and combined these using random-effects model meta-analysis. Between-study heterogeneity was assessed using the I(2) statistic. RESULTS: In 5 statin trials with 32,752 participants without diabetes at baseline, 2749 developed diabetes (1449 assigned intensive-dose therapy, 1300 assigned moderate-dose therapy, representing 2.0 additional cases in the intensive-dose group per 1000 patient-years) and 6684 experienced cardiovascular events (3134 and 3550, respectively, representing 6.5 fewer cases in the intensive-dose group per 1000 patient-years) over a weighted mean (SD) follow-up of 4.9 (1.9) years. Odds ratios were 1.12 (95% confidence interval [CI], 1.04-1.22; I(2) = 0%) for new-onset diabetes and 0.84 (95% CI, 0.75-0.94; I(2) = 74%) for cardiovascular events for participants receiving intensive therapy compared with moderate-dose therapy. As compared with moderate-dose statin therapy, the number needed to harm per year for intensive-dose statin therapy was 498 for new-onset diabetes while the number needed to treat per year for intensive-dose statin therapy was 155 for cardiovascular events. CONCLUSION: In a pooled analysis of data from 5 statin trials, intensive-dose statin therapy was associated with an increased risk of new-onset diabetes compared with moderate-dose statin therapy.
背景：最近的一项荟萃分析表明，他汀类药物治疗与糖尿病风险增加相关。
目的：研究与中等剂量他汀类药物治疗相比，强化剂量他汀类药物治疗是否与新发糖尿病风险增加相关。
数据来源：我们在 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库（1996 年 1 月 1 日至 2011 年 3 月 31 日）中进行文献检索，以确定相关试验。从研究者处获得了未发表的数据。
研究选择：我们纳入了比较强化剂量他汀类药物治疗与中等剂量他汀类药物治疗的随机对照终点试验，且纳入了超过 1000 名随访时间超过 1 年的参与者。
数据提取：每个试验都提供了表格数据，描述了基线特征以及发生糖尿病和主要心血管事件（心血管死亡、非致死性心肌梗死或卒中、冠状动脉血运重建）的参与者人数。我们计算了新发糖尿病和主要心血管事件的试验特异性比值比（OR），并使用随机效应模型荟萃分析对这些结果进行了合并。使用 I(2)统计量评估了研究间的异质性。
结果：在 5 项他汀类药物试验中，共有 32752 名基线无糖尿病的参与者，其中 2749 名发生了糖尿病（1449 名接受强化剂量治疗，1300 名接受中等剂量治疗，强化剂量组每 1000 患者-年多发生 2.0 例），6684 名发生了心血管事件（分别为 3134 名和 3550 名，强化剂量组每 1000 患者-年少发生 6.5 例），加权平均随访时间为 4.9（1.9）年。与接受中等剂量治疗的患者相比，接受强化剂量治疗的患者新发糖尿病的 OR 为 1.12（95%置信区间 [CI]，1.04-1.22；I(2) = 0%），心血管事件的 OR 为 0.84（95% CI，0.75-0.94；I(2) = 74%）。与中等剂量他汀类药物治疗相比，强化剂量他汀类药物治疗每年每发生 1 例新发糖尿病需治疗的患者数为 498 例，而每年每发生 1 例心血管事件需治疗的患者数为 155 例。
结论：在 5 项他汀类药物试验的汇总分析中，与中等剂量他汀类药物治疗相比，强化剂量他汀类药物治疗与新发糖尿病风险增加相关。
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