Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 20167359 · doi:10.1016/S0140-6736(09)61965-6
What was done
A systematic review and random-effects meta-analysis was conducted using Medline, Embase, and the Cochrane Central Register of Controlled Trials (1994–2009) for published and unpublished randomized controlled endpoint trials of statins. Eligible trials required more than 1,000 participants, identical follow-up across treatment arms, and duration exceeding 1 year. Trials involving organ transplant recipients or patients requiring hemodialysis were excluded. Heterogeneity was evaluated using the I² statistic, and trial-level meta-regression was performed.
What was found
Across 13 trials with 91,140 participants and a mean follow-up of 4 years, 4,278 individuals developed diabetes (2,226 assigned to statins vs 2,052 assigned to control). Statin therapy was associated with a 9% increased risk of incident diabetes (odds ratio 1.09; 95% CI 1.02–1.17) with low heterogeneity (I² = 11%). Meta-regression showed the risk was highest in trials enrolling older participants, whereas baseline BMI and degree of LDL-cholesterol lowering did not account for residual risk variation. The number needed to harm was 255 (95% CI 150–852) patients treated for 4 years per one excess diabetes case.
Why it matters
This analysis establishes a modest but statistically significant link between statin therapy and new-onset diabetes. Because the absolute risk is low (1 excess case per 255 patients over 4 years), the cardiovascular risk reductions from statins continue to support standard clinical indications.
Limits
The analysis was restricted to trials with over 1,000 participants and duration over 1 year, omitting data from smaller or shorter studies. Specific clinical populations (hemodialysis, organ transplant) were excluded, and the abstract does not detail whether incident diabetes risk varies by individual statin molecule or specific dosing regimens.
Cited by
- supports High doses of potent statins like rosuvastatin and atorvastatin increase the risk of developing type 2 diabetes.
- contradicts Approximately 1 in 100 (or up to 1 in 50) people prescribed statins develop type 2 diabetes as a result of the medication.