THE PROGNOSIS OF PATIENTS WITH ALCOHOLIC LIVER-DISEASE - AN INTERNATIONAL RANDOMIZED, PLACEBO-CONTROLLED TRIAL ON THE EFFECT OF MALOTILATE ON SURVIVAL

The aim of this study was to examine the effect of malotilate on survi val in patients with alcoholic liver disease and to determine prognost ic variables for survival. Four hundred and seven patients with alcoho lic liver diseases, from seven European liver units, entered a randomi zed placebo-controlled, double-blind trial: 140 patients received malo tilate 1500 mg/day, 133 patients received 750 mg/day, and 134 patients received placebo. The patients were included in the study over a peri od of 31/2, years, and the study was closed 1 year after the entry of the last patient. Eighty-four patients died (35, 19, 30 patients in gr oups 1500 mg/day, 750 mg/day, and placebo, respectively). Survival was slightly better in the 750 mg/day group than in the two other treatme nt groups, when tested by conventional log-rank tests (p=0.06). Howeve r, a treatment effect was supported by a highly significant (p=0.006) non-proportionality of the death intensity in patients receiving 750 m g/day against those receiving either 1500 mg/day or placebo. Prognosti c variables for survival were evaluated using the multiple Cox regress ion analysis of clinical and laboratory variables and with or without liver histology variables, as determined at entry into the study. The analysis was stratified for the three treatment regimens. In the analy sis including liver histology variables, independent significant progn ostic variables were: years of high alcohol intake, prothrombin index, alkaline phosphatases, creatinine, immunoglobulin M, white blood cell count, and liver cell steatosis. In the analysis without liver histol ogy variables, prognostic variables were: years of high alcohol intake , prothrombin index, alkaline phosphatases, creatinine, and immunoglob ulin M. (C) Journal of Hepatology.