Elevated serum aminotransferases, chronic liver disease and statins

After statin-induced myalgia and severe dyslipidemia refractory to therapy, the third most common reason patients with dyslipidemia are sent to see us is elevated serum aminotransferases and/or pre-existing liver disease.

Elevations of serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) are common in people taking statin therapy. Indeed, the FDA-approved prescribing information includes recommendations for monitoring serum aminotransferases for all currently marketed statins. The problem, however, is that elevated serum aminotransferases are common in the general population, whether they are on statin therapy or not. Many patients are taken off of statins and told they cannot be on such lipid-lowering therapy because of elevated ALT/AST.

In 2006, the Liver Expert Panel of the National Lipid Association Statin Safety Task Force assessed the data and concluded that although elevated serum aminotransferases are frequently encountered in patients on statin therapy, there is no evidence that it is an indication of statin-induced liver injury or damage. The Liver Expert Panel believes the scientific evidence does not support routine monitoring of serum aminotransferases in patients on statins. They suggested regulatory authorities reconsider the recommendations for routine monitoring of liver enzymes in patients on statins.

Another common scenario is patients with pre-existing fatty liver disease and other chronic liver disease, such as chronic hepatitis C. Many are not offered statin therapy because of concerns about the statin possibly worsening their liver disease. The Liver Expert Panel concluded that stable chronic liver disease and compensated cirrhosis should not be a contraindication for statin therapy in patients in whom such medication would otherwise be indicated. They advised for statins to be withheld only in those patients with acute hepatitis, decompensated cirrhosis or end-stage liver disease, as would be suggested by elevated bilirubin, coagulopathy, and/or hepatic encephalopathy.

Despite the lack of evidence to support monitoring of serum aminotransferases, many clinicians will continue to monitor until there is a change in the prescribing information. Not following the package insert for monitoring is considered off-label prescribing. A clinician who does not follow the package insert could possibly be liable if a patient develops liver injury on a statin, no matter whether it is related to the drug or not.

Based on the science and current expert consensus recommendations, isolated elevation of serum aminotransferases in patients with or without chronic liver disease is not an absolute contraindication against using statins. Nevertheless, it is essential for clinicians to explain to their patients the potential risks and benefits of all medications, including statins.

For more information:

Cohen DE. Am J Cardiol. 2006; 97[suppl]:77C–81C.
Tandra S. Current Treatment Options in Cardiovascular Medicine. 2009;11:272–278.