Evidence-Based Answers

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Statins associated with developing DM

Clinical Question:
Is statin use associated with developing diabetes, independent of body mass index?

Bottom Line:
The use of statins is associated with an increased risk of developing diabetes, independent of baseline body mass index. Treating 255 patients with statins for 4 years will cause 1 extra case of diabetes. However, although the use of statins was associated with an increased risk of developing diabetes, it is possible that this is a reflection of more complex metabolic issues involving hyperlipidemia, diabetes, and coronary artery disease, or a reflection of survivorship (patients who take statins may live longer and have more time to develop diabetes). (LOE = 1a)

Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375(9716):735-742.  [PMID:20167359]

Study Design:
Meta-analysis (randomized controlled trials)

Self-funded or unfunded

Various (meta-analysis)

These authors systematically searched several databases to find randomized placebo-controlled trials of statins that reported the rate of newly diagnosed diabetes and included at least 1000 patients and at least 1 year of follow-up. Additionally, the trials could not include patients with established diabetes. Finally, the authors excluded those studies that only used surrogate cardiovascular end points and did not follow each treatment group in an identical manner. The authors then contacted the principal investigators of each study to obtain the original data for each patient. Ultimately, 13 studies with more than 90,000 patients were included (45,221 patients using a statin and 45,619 control patients). After an average of 4 years of follow-up, 4.9% of patients who took statins developed diabetes compared with 4.5% of control patients. Treating 255 (95% CI, 150 - 852) patients with statins for 4 years will cause 1 extra case of diabetes. The annualized rate of developing diabetes was 12.23 cases per 1000 patient-years in the statin group and 11.25 cases per 1000 patient-years in control patients. The authors did some exploratory analyses and found that the risk of developing diabetes was higher in older participants and that baseline body mass index did not seem to play a role. The authors found the data were consistent across the studies and found no statistical evidence of publication bias.


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