November 23rd, 2010
Greek Study Offers Reassurance About Statin Usage in Patients with Abnormal Liver Tests
Larry Husten, PHD
In the GREACE (Greek Atorvastatin and Coronary Heart Disease Evaluation) study, 1600 patients with coronary heart disease were randomized to atorvastatin or usual care; of these, 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 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% to 30% of patients who need statins might be denied treatment because of liver functions tests. “Statin-induced hepatotoxicity is a myth,” he writes. He recommends that statin manufacturers 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.”
The results of GREACE study gives a sence of relief because previously it was not quite clear that what to do with the patients who need a satain but have moderately raised liver enzymes, but one should not forget to monitor the liver enzymes 1 to 3 months after starting a statin and should consider stopping the drug if liver enzymes are elevated more than three times of the normal value.
Competing interests pertaining specifically to this post, comment, or both:
Non
I restart a lot of statins previously stopped for LFT issues. I tell patients that real liver problems have NEVER been associated with statins alone. There is also safety data in patients with elevated LFTs and hep B or C. I think the LFT checking recommendation was withdrawn in the UK (not sure).
Competing interests pertaining specifically to this post, comment, or both:
None
I have a patient who had a baseline elevated transaminases. When patient came to my care, since the patient had a history of CAD s/p stent and LDL = 125, I restarted statin. In the mean time, I did try to evaluated the cause of baseline elevated LFTs. The etiological evaluation for her baseline abnormal liver function is pointing towards NASH. I am wondering if lack of harm is also true with NASH.
I have several patients with elevated transaminasas when I saw them for the first time, they started Statins and nothing happen.But I did not see improvent in liver test