Neither pentoxifylline nor prednisolone reduced 28-day mortality, 90-day mortality, or 1-year mortality among adults with alcoholic hepatitis in a multicenter clinical trial comparing the two agents, according to a report published online April 23 in the New England Journal of Medicine.
Pentoxifylline and glucocorticoids are the only drugs endorsed for this indication in treatment guidelines from the American Association for the Study of Liver Disease and the European Association for the Study of the Liver. However, the evidence in support of both has been conflicting, and their use remains controversial. The Steroids or Pentoxifylline for Alcoholic Hepatitis (SOPAH) study was a randomized, double-blind trial comparing the two drugs against each other and against placebo in 1,103 patients enrolled during a 3-year period at 65 hospitals across the United Kingdom, said Dr. Mark R. Thursz of Imperial College, London, and his associates.
The primary endpoint of the study, mortality at the conclusion of the 28-day course of treatment, was 14% in the group taking prednisolone plus placebo, 19% in those taking pentoxifylline plus placebo, 13% in those taking both prednisolone plus pentoxifylline, and 17% in those taking two placebos – all nonsignificant differences. In addition, neither active drug affected mortality or the need for liver transplantation at 90 days or at 1 year, the investigators reported (N. Engl. J. Med. 2015 April 23 [doi:10.1056/NEJMoa1412278]).
Cumulative mortality at 1 year was “alarming” but nearly identical between the groups who received the two active agents and the groups who did not: 56% with pentoxifylline and 57% without it; 57% with prednisolone and 56% without it.
Infection accounted for 24% of all deaths, but the number of infections among patients receiving prednisolone was no higher than that for the other patient groups, Dr. Thursz and his associates added.