There were 3.2 events per 100 patient-years in the atorvastatin group, compared with 10 events per 100 patient-years in those not on atorvastatin, a 68% reduction in RR (P<.0001) and an NNT of 15 per year to prevent one cardiovascular event. The risk reduction in cardiovascular events was greater in patients with NAFLD (68%) than in patients with normal liver tests (39%).
An added benefit was the reduction in ALT/AST levels during treatment for patients with NAFLD who were taking a statin, an average decrease of 47% in AST levels and 35% in ALT levels. In addition, 89% of the patients in the statin group had normal ALT, AST, and gamma-glutamyl transferase levels by the end of the 3-year follow-up. Patients with NAFLD who did not receive statins had a 12% increase in AST and ALT by the end of the 3-year study.
Only 10 of 880 patients taking statins developed liver enzymes more than 3× ULN. In 3 of these patients, dose adjustments brought the liver enzymes back to normal. Only 7 (<1%) patients who received a statin had to discontinue therapy because of liver-related adverse effects.
WHAT’S NEW: Liver enzymes improve, with few adverse effects
Preliminary studies have shown an improvement in liver enzymes in patients with NAFLD treated with a statin.9,10 This is the first study to show survival benefits and significant reduction in major cardiovascular morbidity for such patients, as well.
This is also the first large-scale study that shows that treating NAFLD patients with a statin decreases liver enzyme levels, with minimal adverse effects.
CAVEATS: Differences in groups, few women could skew results
This study cannot be considered the final word on this topic. Patients in the “structured care” group were followed at a university clinic, while those in the “usual care” group were followed by either a family physician or a cardiologist outside the hospital, based on their choice. There may have been other differences in the care received by the 2 groups that could account for the difference in mortality and morbidity reduction.
In addition, study participants had coronary artery disease, and atorvastatin was not used for primary prevention. Moreover, nearly 80% of the study participants were male, which raises the question of generalizability. And this study was a post hoc analysis of the larger GREACE study, which also raises concerns about the validity of findings.
In the absence of a larger prospective RCT, however, this is the best available evidence to support the use of statins in this population, and suggests that treating patients with NAFLD with statins is safe and effective.
CHALLENGES TO IMPLEMENTATION: Extensive Dx tests are costly
Study participants were evaluated to rule out other causes of their abnormal liver tests, with extensive laboratory tests and an ultrasound evaluation of the liver. Such extensive testing may be cost prohibitive in some situations.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.