High tierMeta Analysis Of RctsCitation verified
Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials
Naveed Sattar, David Preiss, Heather M Murray, Paul Welsh, Ian Ford - The Lancet, 2010
The defining quantification of the statin-diabetes harm. Pooling 13 statin RCTs, statin therapy was associated with a 9% relative increase in incident diabetes (OR 1.09). In absolute terms the harm is small - about one extra case for every 255 patients treated for four years - which the authors judged low against the cardiovascular benefit.
Key findings
- Incident diabetes: OR 1.09 (95% CI 1.02-1.17), little heterogeneity (I-squared 11%).
- Number-needed-to-harm: ~255 patients treated for 4 years per extra diabetes case (95% CI 150-852).
- Authors judged the absolute risk low relative to coronary-event reduction.
Effect measures
- Odds Ratio: 1.09 (incident diabetes)95% CI 1.02-1.17
- Number Needed To Harm: 255 treated for 4 years per extra diabetes case95% CI 150-852
Why this evidence tier (High)
- Risk of bias:
- Collaborative meta-analysis of randomized trials; low risk of bias for this harm estimate.
- Precision:
- Very large (91,140); precise estimate with little heterogeneity.
- Directness:
- Directly measures incident diabetes across statin RCTs.
- Consistency:
- Low heterogeneity; later work shows the effect is dose-dependent.
- Funding / COI:
- The meta-analysis itself received no external funding; several authors report ties to statin manufacturers, and the pooled trials were largely industry-sponsored.
High certainty that statins modestly raise incident diabetes; the absolute effect is small and concentrated in the already-predisposed.
- Population:
- 91,140 participants across 13 randomised statin endpoint trials (each >1000 patients, follow-up >1 year), excluding transplant and dialysis patients; mean follow-up 4 years.
- Conflicts of interest:
- No funding for the meta-analysis itself. Several authors report honoraria, consultancy, or grants from statin manufacturers; the underlying trials were largely industry-sponsored.
- Funding:
- None (the meta-analysis received no external funding, per the abstract).
Limitations
- The source says "incident diabetes" generically; type is not specified, though these populations are predominantly type 2.
- Trial-level diabetes ascertainment was not the trials primary purpose.
How this study is used
- Strongly supportsDo statins increase the risk of developing diabetes?