This article is more than 5 years old. Information may no longer be current.

Pentoxifylline did not improve OS in patients with alcoholic hepatitis

In a clinical study of 1,103 patients with alcoholic hepatitis, pentoxifylline treatment did not increase short-term or medium-term survival, according to newly published findings in the New England Journal of Medicine.

Researchers, including Mark R. Thursz, MD,  professor of hepatology at Imperial College and consultant in hepatology at St Mary's Hospital, London, randomly assigned patients with alcoholic hepatitis to one of four groups: received a pentoxifylline-matched placebo and a prednisolone-matched placebo (n=269), received 40 mg of prednisolone daily with a pentoxifylline-matched placebo (n=266), received 400 mg of pentoxifylline three times daily and a prednisolone-matched placebo (n=258), or received both 40 mg of prednisolone and 400 mg of pentoxifylline (n=260) three times daily for 28 days according to the research. The primary end point was mortality at 28 days and secondary endpoints included mortality at 90 days and 1 year.  

Overall, 1,053 patients had available data and were included in the final analysis. In the placebo-placebo group, 17% of patients died at 28 days (n=45); 14% of patients in the prednisolone-placebo group died (n=38); 19% of patients in the pentoxifylline-placebo group died (n=50); and 13% of patients in the prednisolone-pentoxifylline group died (n=35).

The odds ratio for 28-day mortality with prednisolone was 0.72 (95% CI, 0.52-1.01) and 1.07 (95% CI, 0.77-1.49) in the pentoxifylline group. At 90 days and 1-year, mortality rates were not different between the groups, according to the research.

Forty-two percent of the patients reported a serious adverse event, with 20% of all of them resulting in death. More patients treated with prednisolone experienced serious infections compared with patients not treated with prednisolone (13% vs. 7%; P = .002). 

“Pentoxifylline did not improve outcomes in patients with alcoholic hepatitis,” the researchers concluded. “The findings suggest that the administration of 40 mg of prednisolone daily for 1 month may have a beneficial effect on short-term mortality, but not on the medium-term or long-term outcomes of alcoholic hepatitis.” – by Melinda Stevens

Disclosure: Thursz reports receiving lecture fees and consulting fees from Gilead Sciences, Bristol-Myers Squibb, AbbVie and Abbott. Please see the full study for a list of all other authors’ relevant financial disclosures.