Are cholesterol lowering drugs safe for patients at risk for diabetes?
Cholesterol lowering drugs (statins) such as Lipitor and Crestor are commonly prescribed for patients with elevated low density lipoproteins (“bad cholesterol”) and those with cardiovascular disease. Recently these drugs have come under scrutiny because of increasing evidence that they increase one’s susceptibility to diabetes.
Because of the growing evidence, the US Food and Drug Administration made a requirement last February that manufacturers of statins should place a warning of this increased risk on their labels. A new study set out to evaluate that increased risk. It found that statins increased the risk of diabetes; however, it also was found to have some benefits. The study was published on August 9 in the journal The Lancet.
Paul Ridker, a cardiologist and professor of medicine at Harvard Medical School, and colleagues conducted a meta-analysis to evaluate the benefits and risks of statins. (A meta-analysis is a review of several studies of similar design to validate findings.). The meta-analysis included data from 22 trials of statin versus control (134,537 subjects who were followed from four to eight years) and five trials of more versus less statin (39,612 subjects who were followed for an average of 5.1 years). The researchers looked for major vascular events were major coronary events (i.e., non-fatal myocardial infarction (heart attack) or coronary death), strokes, or coronary revascularizations. The subjects were separated into five categories of baseline 5-year major vascular event risk on control therapy (no statin or low-intensity statin; less than 5%, 5% to less than 10%, 10% to less than 20%, 0% to less than 30%, and more than 30%); in each, the rate ratio (RR) per 1.0 mmol/L LDL cholesterol reduction was estimated.
The researchers found that reduction of LDL cholesterol with a statin reduced the risk of major vascular events (RR 0.79 per 1.0 mmol/L reduction); the reduced risk was not significantly related to age, sex, baseline LDL cholesterol, or previous vascular disease. The proportional reduction in major vascular events was at least as significant in the two lowest risk categories as in the higher risk categories. For stroke, the reduction in risk in participants with 5-year risk of major vascular events lower than 10% was also similar to that seen in higher risk categories (trend p=0•3). In subjects without a history of vascular disease, statins reduced the risks of vascular and all-cause mortality, and the proportional reductions were similar by baseline risk. There was no evidence that reduction of LDL cholesterol with a statin increased cancer incidence, cancer mortality, or other non-vascular mortality.
The authors conclude that individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L reduction in LDL cholesterol produced an absolute reduction in major vascular events of about 11 per 1000 over five years. They noted that this benefit greatly exceeds any known hazards of statin therapy. Under present guidelines, such individuals would not typically be regarded as suitable for LDL-lowering statin therapy. They suggested that in view of their findings, these guidelines might need to be reconsidered.
Take home message:
This study recommends that individuals with a low risk for a cardiovascular event might benefit from statins. It should be noted that this study was funded by Astra-Zeneca, the maker of Crestor.
Reference: The Lancet
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