Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis.
Level 1 - systematic review of randomized trials
Meta-analysis of randomized controlled trials
PubMed 21693744 · doi:10.1001/jama.2011.860
What was done
A systematic review and random-effects meta-analysis of randomized controlled trials indexed in MEDLINE, EMBASE, and Cochrane CENTRAL (1996–2011), alongside unpublished data. Eligible trials included more than 1,000 participants without baseline diabetes followed for over 1 year, directly comparing intensive-dose versus moderate-dose statin therapy for incident diabetes and major cardiovascular events.
What was found
Across 5 trials with 32,752 participants followed for a weighted mean of 4.9 years, intensive-dose statin therapy was associated with an increased risk of new-onset diabetes compared with moderate-dose therapy (OR 1.12, 95% CI 1.04–1.22; I² = 0%; 2.0 additional cases per 1,000 patient-years; number needed to harm per year = 498). Concurrently, intensive therapy reduced major cardiovascular events (OR 0.84, 95% CI 0.75–0.94; I² = 74%; 6.5 fewer cases per 1,000 patient-years; number needed to treat per year = 155).
Why it matters
This study demonstrates a dose-dependent diabetogenic effect of statin therapy while confirming that the cardiovascular benefits of intensive-dose statins continue to significantly outweigh the absolute excess risk of diabetes.
Limits
The analysis is restricted to 5 large clinical trials, limiting evaluation of specific statin molecules or patient subgroups. Significant heterogeneity was present for cardiovascular event reporting (I² = 74%). Diagnostic criteria for incident diabetes may have varied across the included original trials.
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.