Fulminant hepatic failure (FHF) is a severe, life-threatening disorder. Pre
vious studies have suggested that intravenous prostaglandin treatment may i
mprove survival in FHF, The present study was performed to further investig
ate the possible benefit of intravenous prostaglandin E-1 (PGE(1)) for pati
ents with FHF. A total of 18 patients, all excluded as candidates for hepat
ic transplantation, were studied. Thirteen of 18 participated in a randomiz
ed, double-blind, placebo-controlled trial, PGE1 was administered by contin
uous infusion at a dose of 10 to 40 mu g/h as tolerated. After 48 hours of
blinded treatment, 3 of 7 patients randomized to placebo were converted to
open-label PGE(1) for lack of biochemical and/or clinical improvement. Mean
values for alanine transaminase, aspartate transaminase, total bilirubin,
prothrombin time, factor V percent, factor VII percent, hepatic encephalopa
thy score, days from onset of symptoms to initiation of treatment, and caus
e of FHF were similar between treatment groups. Ten of 18 patients (55%) en
rolled in this trial survived, However, survival was not different between
PGE(1)-(60%) and placebo (50%) treated patients, The greatest predictor of
survival was the number of days from onset of symptoms to hospitalization,
which was significantly (P = .002) shorter for survivors (3.3 v 12.4 days),
regardless of PGE(1) treatment. Six of 8 patients (75%) who began PGE(1) t
herapy and 4 of 5 placebo-treated patients (80%) hospitalized within 10 day
s of onset of symptoms survived. By contrast, all 5 patients who were hospi
talized and subsequently began PGE(1) treatment 10 days or longer after the
onset of symptoms died. We conclude that early recognition and hospitaliza
tion is the most important factor in reduction of mortality from FHF. It is
unclear whether PGE(1) treatment is beneficial when administered during th
is period. However, it is apparent that PGE(1) was not effective for treatm
ent of FHF if treatment started more than 10 days after onset of this clini
cal syndrome. Copyright (C) 1998 by the American Association for the Study
of Liver Diseases.