Department of Global Health and Population, Harvard School of Public Health, Boston, MA, USA.
Diabetes Care. 2013 May;36(5):1236-40. doi: 10.2337/dc12-1756. Epub 2012 Dec 17.
Two meta-analyses of randomized trials of statins found increased risk of type 2 diabetes. One possible explanation is bias due to differential survival when patients who are at higher risk of diabetes survive longer under statin treatment.
We used electronic medical records from 500 general practices in the U.K. and included data from 285,864 men and women aged 50-84 years from January 2000 to December 2010. We emulated the design and analysis of a hypothetical randomized trial of statins, estimated the observational analog of the intention-to-treat effect, and adjusted for differential survival bias using inverse-probability weighting.
During 1.2 million person-years of follow-up, there were 13,455 cases of type 2 diabetes and 8,932 deaths. Statin initiation was associated with increased risk of type 2 diabetes. The hazard ratio (95% CI) of diabetes was 1.45 (1.39-1.50) before adjusting for potential confounders and 1.14 (1.10-1.19) after adjustment. Adjusting for differential survival did not change the estimates. Initiating atorvastatin and simvastatin was associated with increased risk of type 2 diabetes.
In this sample of the general population, statin therapy was associated with 14% increased risk of type 2 diabetes. Differential survival did not explain this increased risk.
两项他汀类药物随机试验的荟萃分析发现，2 型糖尿病的风险增加。一种可能的解释是，由于糖尿病风险较高的患者在他汀类药物治疗下存活时间更长，从而导致了生存偏差。
我们使用了英国 500 家全科医生的电子病历，并纳入了 2000 年 1 月至 2010 年 12 月期间年龄在 50-84 岁的 285864 名男性和女性的数据。我们模拟了他汀类药物的假设随机试验的设计和分析，估计了意向治疗效果的观察模拟，并使用逆概率加权法调整了生存差异偏差。
在 120 万人年的随访期间，有 13455 例 2 型糖尿病和 8932 例死亡。他汀类药物的起始治疗与 2 型糖尿病的风险增加相关。在调整潜在混杂因素之前，糖尿病的风险比（95%CI）为 1.45（1.39-1.50），调整后为 1.14（1.10-1.19）。调整生存差异并没有改变这些估计值。起始阿托伐他汀和辛伐他汀与 2 型糖尿病的风险增加相关。
在这个普通人群样本中，他汀类药物治疗与 2 型糖尿病风险增加 14%相关。生存差异并不能解释这种风险增加。
