Statins may raise blood glucose: Should we be concerned?
Thursday, March 22, 2012
by Ronald M. Goldenberg, MD, FRCPC, FACE
On February 28, 2012, the US Food and Drug Administration (FDA) approved new safety label changes for the statin class of cholesterol-lowering drugs.1 These changes included a statement regarding the effect of statins on blood glucose. The FDA stated that “increases in blood sugar levels have been reported with statin use.” However, they also indicated that “the cardiovascular benefits of statins outweigh these small increased risks.”
Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) reported a 27% increase in investigator-reported diabetes mellitus in rosuvastatin-treated patients compared to placebo-treated patients, but the absolute risk increase was small, with new onset diabetes reported in 2.4% of those on placebo and in 3.0% of those treated with rosuvastatin.2 There was a small but statistically significant difference in median A1C levels in JUPITER after 24 months of therapy: 5.9% in the statin-treated group and 5.8% in the placebo group.2 The small rise in A1C suggests a mild progression of dysglycemia with statin therapy.
The benefit of statin therapy outweighing the risk of diabetes would be expected to be even greater when accounting for the effect of statins on strokes and the need for revascularisation, in addition to the reduction in coronary events.
A further meta-analysis examined the effect of intensive-dose versus moderate-dose statin therapy on the risk of diabetes.4 In 5 statin trials with 32,752 participants, intensive-dose statin therapy was associated with a 12% increased risk for incident diabetes (OR 1.12; 95% CI 1.04-1.22) and a 16% decreased risk for cardiovascular events (OR 0.84; CI, 0.75-0.94). As compared with moderate-dose statin therapy, the number needed to harm per year for intensive-dose statin therapy was 498 for new-onset diabetes while the number needed to treat per year for intensive-dose statin therapy was 155 for cardiovascular events.
What does all these mean for our diabetes patients or those at risk of diabetes being treated with statins? There are inherent risks and benefits with any pharmacotherapy. While there is evidence that statins can increase the risk of diabetes or raise glucose levels, the absolute risk is quite small. The benefits of statin therapy in reducing cardiovascular events far outweigh the small risk of worsening glycemic control. The Canadian Diabetes Association suggests that people with diabetes who are currently taking a statin continue their medication unless instructed otherwise by their healthcare provider. Stopping statin therapy is not recommended based on the recent FDA warnings especially because the risk of ongoing statin therapy is small and discontinuation of statin therapy may increase the risk of vascular events.
Available at: http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm