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Adverse Effect of Statins in Diabetes?

January 1, 2013

There have been several recent labeling changes to statins by the FDA.1 One notable example is the concern that statins may increase hemoglobin A1c and/or fasting plasma glucose. All statins have made this new labeling change. These changes were mandated by the FDA following review of published articles on the association between statins and newly diagnosed diabetes. One of the major reviewed articles was a meta-analysis that included six trials.2 Five of the included studies were hypothesis testing and one, the West of Scotland Coronary Prevention study (WOSCOPS) was hypothesis generating. Follow-up ranged between a median of 1.9 years to over 5 years. The studies, in total, reported on 2,082 incident cases of diabetes. The criteria for diagnosis of diabetes varied between the studies and were either physician reported or used standardized diagnostic criteria.

The JUPITER trial reported a 27% increase in investigator-reported diabetes in rosuvastatin-treated patients, compared to placebo-treated patients. 3 In contrast, the WOSCOPS trial found that statin use had a protective effect against diabetes. The relative risk for incident diabetes in the five hypothesis testing trials was 1.13 (95% CI 1.0-1.24; p=0.007). When the WOSCOPS study was included in the analysis, the relative risk became insignificant at 1.06 (95% CI 0.93-1.23; p=0.38). It is important to note that the WOSCOPS trial used non-standard diagnostic criteria for diabetes diagnosis.

The exact mechanism for glucose intolerance, if real, is unknown but is proposed that statins can interfere with normal glucose metabolism due to a reduction in cellular glucose uptake leading to glucose intolerance. Despite the potential association between statins and diabetes, the benefits of statin therapy largely outweigh the risks and may only require increased monitoring. Future studies should aim at establishing or refuting a causal relationship.

1. FDA drug safety communication: Important safety label changes to cholesterol-lowering statin drugs. Food and Drug Administration 2012. Accessed from: http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm.

2. Rajpathak SN, Kumbhani DJ, Crandall J, et al. Statin therapy and risk of developing type 2 diabetes: A meta-analysis. Diabetes Care 2009; 32: 1924-1929.

3. Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008, 359:2195-2207.

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