Potential conflict of interest: Nothing to report.
Steatohepatitis/Metabolic Liver Disease
Article first published online: 24 AUG 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 54, Issue 5, pages 1610–1619, November 2011
How to Cite
Zein, C. O., Yerian, L. M., Gogate, P., Lopez, R., Kirwan, J. P., Feldstein, A. E. and McCullough, A. J. (2011), Pentoxifylline improves nonalcoholic steatohepatitis: A randomized placebo-controlled trial. Hepatology, 54: 1610–1619. doi: 10.1002/hep.24544
Presented, in part, at the Annual Meeting of the American College of Gastroenterology (ACG), October 2010, San Antonio, TX.
Supported by the American College of Gastroenterology Junior Faculty Career Development Award to Dr. Claudia Zein. Dr. Claudia Zein is also supported by Grant Number KL2 RR024990 from the National Center for Research Resources (NCRR), a component of the NIH and NIH Roadmap for Medical Research. This project was supported by Grant Number M01 RR00080 and Grant Number UL1 RR024989 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH.
- Issue published online: 28 OCT 2011
- Article first published online: 24 AUG 2011
- Accepted manuscript online: 11 JUL 2011 12:31PM EST
- Manuscript Accepted: 27 JUN 2011
- Manuscript Received: 12 APR 2011
The primary aim of this study was to compare the effects of pentoxifylline (PTX) versus placebo on the histological features of nonalcoholic steatohepatitis (NASH). In all, 55 adults with biopsy-confirmed NASH were randomized to receive PTX at a dose of 400 mg three times a day (n = 26) or placebo (n = 29) over 1 year. The primary efficacy endpoint was defined as improvement in histological features of NASH through reduction in steatosis, lobular inflammation, and/or hepatocellular ballooning as reflected by a decrease of ≥2 points in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS). After 1 year, intention-to-treat analysis showed a decrease of ≥2 points in the NAS in 38.5% of patients on PTX versus 13.8% of those on placebo (P = 0.036). Per protocol analysis, a decrease of ≥2 points in the NAS from baseline was observed in 50% of the patients on PTX versus 15.4% of those on placebo (P = 0.01). The mean change in NAS score from baseline was −1.6 in the PTX group, versus −0.1 in the placebo group (P < 0.001). PTX significantly improved steatosis (mean change in score −0.9 versus −0.04 with placebo, P < 0.001) and lobular inflammation (median change −1 versus 0 with placebo, P = 0.02). No significant effects in hepatocellular ballooning were observed. PTX also improved liver fibrosis (mean change in fibrosis score was −0.2 among those on PTX versus +0.4 among those on placebo, P = 0.038). Although not statistically significant (P = 0.17), improvement in fibrosis was observed in a greater proportion (35%) of patients in the PTX group compared to placebo (15%). Adverse effects were similar in both groups. Conclusion: PTX improved histological features of NASH compared to placebo. PTX was well tolerated in patients with NASH (ClinicalTrials.gov number NCT00590161). (HEPATOLOGY 2011)