British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
Trials of statin therapy have had conflicting findings on the risk of development of diabetes mellitus in patients given statins. We aimed to establish by a meta-analysis of published and unpublished data whether any relation exists between statin use and development of diabetes.
We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from 1994 to 2009, for randomised controlled endpoint trials of statins. We included only trials with more than 1000 patients, with identical follow-up in both groups and duration of more than 1 year. We excluded trials of patients with organ transplants or who needed haemodialysis. We used the I(2) statistic to measure heterogeneity between trials and calculated risk estimates for incident diabetes with random-effect meta-analysis.
We identified 13 statin trials with 91 140 participants, of whom 4278 (2226 assigned statins and 2052 assigned control treatment) developed diabetes during a mean of 4 years. Statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1.09; 95% CI 1.02-1.17), with little heterogeneity (I(2)=11%) between trials. Meta-regression showed that risk of development of diabetes with statins was highest in trials with older participants, but neither baseline body-mass index nor change in LDL-cholesterol concentrations accounted for residual variation in risk. Treatment of 255 (95% CI 150-852) patients with statins for 4 years resulted in one extra case of diabetes.
Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change.
None.
他汀类药物治疗试验在给予他汀类药物的患者中糖尿病发病风险的结果相互矛盾。我们旨在通过对已发表和未发表数据的荟萃分析来确定他汀类药物的使用与糖尿病的发展之间是否存在任何关系。
我们从 1994 年到 2009 年在 Medline、Embase 和 Cochrane 对照试验中心注册处搜索了他汀类药物的随机对照终点试验。我们只纳入了超过 1000 例患者的试验，两组的随访时间相同，且超过 1 年。我们排除了器官移植患者或需要血液透析的患者的试验。我们使用 I(2)统计量来衡量试验之间的异质性，并使用随机效应荟萃分析计算出糖尿病发病的风险估计值。
我们确定了 13 项他汀类药物试验，共 91140 名参与者，其中 4278 名（2226 名分配给他汀类药物，2052 名分配给对照组）在平均 4 年的时间里患上了糖尿病。他汀类药物治疗与新发糖尿病的风险增加 9%相关（比值比 [OR] 1.09；95%CI 1.02-1.17），试验之间的异质性较小（I(2)=11%）。荟萃回归显示，他汀类药物治疗的糖尿病发病风险在参与者年龄较大的试验中最高，但基线体重指数或 LDL-胆固醇浓度的变化都不能解释风险的残留变异。255 例（95%CI 150-852）患者接受他汀类药物治疗 4 年，多发生 1 例糖尿病。
他汀类药物治疗与糖尿病发病风险略有增加相关，但无论从绝对值还是与冠心病事件减少的比较来看，风险都较低。对于中重度心血管风险或存在心血管疾病的患者，临床实践不应改变。
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