Among the 1600 patients randomized in the GREACE (Greek Atorvastatin and Coronary Heart Disease Evaluation) study, 437 had moderately abnormal liver tests at baseline suggesting non-alcoholic fatty liver disease (NAFLD).
In a post-hoc analysis of this subset of patients published in the Lancet, the GREACE Study Collaborative Group reported a dramatic 68% reduction in the rate of cardiovascular events in patients in the statin group. Cardiovascular events occurred in 30% of patients in the non-statin group (63 out of 210) compared to 10% of patients in the statin group (22 of 227). The authors say their results mean that “statin treatment is safe and can improve liver tests and reduce cardiovascular morbidity in patients with mild-to-moderately abnormal liver tests that are potentially attributable to non-alcoholic fatty liver disease.” In addition, the authors note that statin treatment was associated with improvement in liver tests.
Finally, the authors acknowledge that the benefits of statins in these patients “might be attributable to the presence of NAFLD, since alcohol misuse and other liver diseases were excluded.”
In an accompanying comment, Ted Bader estimates that 10-30% of patients who need statins might be denied statin treatment because of liver functions tests. “Statin-induced hepatotoxicity is a myth,” he writes. He recommends that statin manufacturers should request FDA approval to remove language about liver toxicity from drug labels. “For too long,” he writes, “a raised ALT after starting a statin has been erroneously thought to represent liver disease. For too long, patients with liver disease have been denied statins for their hypercholesterolemia.”
Here is the Lancet press release: