Statins are associated with a spectrum of adverse events ranging from mild to life-threatening. An editorial by Grundy, which accompanies the current study by Alsheikh-Ali and colleagues, summarizes these adverse events and risk factors for developing complications of statin treatment. The most severe adverse event associated with statin therapy is severe myopathy, which can cause acute renal failure. Although statins can rarely increase serum levels of liver enzymes, there is little evidence that they can promote progressive hepatic disease. Similarly, although statins can cause low-grade proteinuria, there is no evidence that they promote renal failure independently.
Risk factors for these complications include age older than 80 years, small body frame and frailty, chronic renal failure, and concomitant use of gemfibrozil, azole antifungals, macrolide antibiotics, nefazadone, and verapamil. Although the statins are best avoided or maintained at low doses in patients with these risk factors, there is a competing agenda to decrease low-density lipoprotein cholesterol levels in many of these patients. Therefore, more powerful statins such as rosuvastatin have been developed. The current study by Alsheikh-Ali and colleagues examines AERs to the FDA during the first year that rosuvastatin was in use.