The advent of pharmacologic agents which partially inhibit the rate limiting enzyme in cholesterol synthesis (3-hydroxy-3-methylglutaryl Co-A reductase) provided a major advance in preventive medicine. Clinical trials in both primary and secondary prevention have demonstrated reduction in cardiovascular events by statin therapy. However, early epidemiologic studies proposed an inverse relationship between cholesterol levels and mortality. While the epidemiologic studies were controversial and did not establish a cause and effect relationship, concern was raised that aggressive lipid lowering by pharmacological means may be associated with increased risk for noncardiac mortality, including malignancy. The theoretical concern was intensified by meta-analysis of statin trials, which confirmed the reduction in cardiovascular mortality but also demonstrated a potential increase in cancer risk. This review evaluates the epidemiologic and prospective trial data which address the potential relationship between aggressive statin therapy and the risk of malignancy.
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