G. Bertoni et al., ORAL ISOSORBIDE-5-MONONITRATE REDUCES THE REBLEEDING RATE DURING THE COURSE OF INJECTION SCLEROTHERAPY FOR ESOPHAGEAL-VARICES, Scandinavian journal of gastroenterology, 29(4), 1994, pp. 363-370
A double-blind, multicenter trial was carried out to assess the effect
iveness of isosorbide-5-mononitrate in preventing recurrent variceal h
emorrhage during the course of endoscopic sclerotherapy. Seventy-six p
atients with their first bleeding episode from esophageal varices were
randomly allocated, after initial control of hemorrhage, to groups re
ceiving either 50 mg/day oral isosorbide-5-mononitrate retard (37 pati
ents) or an identical placebo (39 patients) until variceal eradication
. Sclerotherapy was performed at weekly intervals, and varices were in
tra- and para-variceally injected with 1% polidocanol until eradicatio
n. If rebleeding occurred, additional sclerotherapy was performed. Fou
r (10.8%) patients rebled in the isosorbide group, compared with 15 (3
8.4%) in the placebo group (p = 0.01). The total number of rebleeding
episodes was also significantly lower in the isosorbide group (5 versu
s 19, p = 0.043), whereas comparison between major versus minor reblee
dings was not significant. The median transfusion requirement per blee
ding episode was not significantly different in the two groups, althou
gh the cumulative number of blood units transfused was over threefold
greater (22 versus 70) in the placebo group. Two (5.4%) deaths occurre
d among isosorbide-treated patients and nine (17.9%) among placebo pat
ients (NS). The number of sclerotherapy sessions and the time required
to obtain variceal eradication were also comparable in the two groups
. Finally, the nitrovasodilator was well tolerated, requiring withdraw
al for severe headache in only one patient. In conclusion, isosorbide-
5-mononitrate reduces the rebleeding rate and the number of rebleeding
episodes before variceal eradication in patients treated with sclerot
herapy.