Statins: Hepatic Disease and Hepatotoxicity Risk

The hydroxy-methyl glutaryl coenzyme A (HMG-CoA) reductase inhibitors generally have a good safety profile and are one of the most prescribed drugs in Europe. Nevertheless, differences in physicochemical and pharmacokinetic properties statins may translate into relevant differences in long term safety. In clinical trials, all lipid-lowering agents have been associated with mild asymptomatic elevation of aminotransferase enzymes. Studies that evaluate the risk of hepatotoxicity from statins in hyperlipidemic subjects with elevated baseline serum transaminases are lacking and furthermore, statins are considered contraindicated in patients with chronic liver disease. However, clinical and biochemical monitoring is routinely recommended or required, often to make up for the lack of information on the true risk of clinically significant liver toxicity of these agents in individuals both with and without underlying liver disease although there is no evidence that monitoring reduces the rate of hepatotoxicity. This article will review what is and what is not known about hepatic disease and hepatotoxicity risk due to the statins and offers recommendations for the safe and rational use of this group of drugs in the setting of specials situations.