Statins, Cardiovascular Disease, and Drug Safety
Adverse Drug Reaction Reporting Systems
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Available for almost 2 decades, the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or statins, have emerged at the forefront of preventive drugs for cardiovascular disease because of a substantial clinical trial database demonstrating that statins reduce the risk for coronary artery disease morbidity and death across a broad range of at-risk patient cohorts. Although generally well tolerated, statins may be associated with infrequent adverse events that warrant serious and frank discussion, including myopathy and rhabdomyolysis. In 2005, the National Lipid Association (NLA), a multidisciplinary, nonprofit association of healthcare providers and researchers in the lipid field, convened a Safety Task Force to undertake an intensive, fair-minded evaluation of available data on the effects of statins on muscle, liver, kidneys, and the brain. In the end, physicians and patients must weigh the potential clinical benefits of statin treatment against the potential risks when deciding whether to initiate treatment.