Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials

Naveed Sattar, David Preiss, Heather M. Murray, Paul Welsh, Brendan M. Buckley, Anton JM de Craen, Sreenivasa Rao Kondapally Seshasai, John J. McMurray, Dilys J. Freeman, J. Wouter Jukema, Peter W. Macfarlane, Chris J. Packard, David J. Stott, Rudi G. Westendorp, James Shepherd, Barry R. Davis, Sara L. Pressel, Roberto Marchioli, Rosa Maria Marfisi, Aldo P. MaggioniLuigi Tavazzi, Gianni Tognoni, John Kjekshus, Terje R. Pedersen, Thomas J. Cook, Antonio M. Gotto, Michael B. Clearfield, John R. Downs, Haruo Nakamura, Yasuo Ohashi, Kyoichi Mizuno, Kausik K. Ray, Ian Ford

Research output: Contribution to journalArticlepeer-review

2052 Scopus citations


Background: Trials of statin therapy have had conflicting findings on the risk of development of diabetes mellitus in patients given statins. We aimed to establish by a meta-analysis of published and unpublished data whether any relation exists between statin use and development of diabetes. Methods: We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from 1994 to 2009, for randomised controlled endpoint trials of statins. We included only trials with more than 1000 patients, with identical follow-up in both groups and duration of more than 1 year. We excluded trials of patients with organ transplants or who needed haemodialysis. We used the I2 statistic to measure heterogeneity between trials and calculated risk estimates for incident diabetes with random-effect meta-analysis. Findings: We identified 13 statin trials with 91 140 participants, of whom 4278 (2226 assigned statins and 2052 assigned control treatment) developed diabetes during a mean of 4 years. Statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1·09; 95% CI 1·02-1·17), with little heterogeneity (I2=11%) between trials. Meta-regression showed that risk of development of diabetes with statins was highest in trials with older participants, but neither baseline body-mass index nor change in LDL-cholesterol concentrations accounted for residual variation in risk. Treatment of 255 (95% CI 150-852) patients with statins for 4 years resulted in one extra case of diabetes. Interpretation: Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change. Funding: None.

Original languageEnglish (US)
Pages (from-to)735-742
Number of pages8
JournalThe Lancet
Issue number9716
StatePublished - 2010

ASJC Scopus subject areas

  • Medicine(all)


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