| Abstract: | Statins are generally well tolerated and shown to have a good safety profile. In clinical trials a similar proportion of patients randomized to statins and placebo treated developed abnormal liver tests. However, idiosyncratic drug-induced liver injury (DILI) is a rare adverse reaction and clinical trials are underpowered to detect uncommon side effects. Although probably very rare, idiosyncratic DILI due to statins has been reported among other drugs in all major prospective and retrospective series on DILI. A summary of 40 cases of statin hepatoxicity has been published and, a series of 76 cases suspected statin induced liver injury has recently been published. In the last mentioned series, three patients died and/or underwent liver transplantation and three cases had a rechallenge with the same statin which produced a similar pattern of liver injury. Statin therapy appears to be safe in the treatment of non-alcoholic fatty liver disease, in compensated patients with chronic hepatitis B or C. Statins have also been shown to have an inhibitory effect on hepatitis C virus replication in vitro. Retrospective data as well as data from a recent randomized controlled trial suggest that statin therapy might be a useful adjunct to standard combination antiviral therapy in patients with chronic hepatitis C. Statin therapy seems to be related to a reduced risk for hepatocellular carcinoma in patients with chronic liver disease, but randomized data are lacking. |
