Enprostil, a synthetic
PGE2, has been shown to have an inhibitory effect on gastric acid secretion, a mucoprotective effect and a postprandial lowering effect on
gastrin. A double blind randomized study was performed in 80 patients, in order to evaluate the efficacy and safety
enprostil (35 mu b.i.d) as compared to
cimetidine (400 mg b.i.d) in
duodenal ulcer. Healing rates after two, four and six weeks of treatment, as based on endoscopic evaluation, were 35, 72 and 83 p. 100 for
enprostil and 45, 73 and 83 p. 100 for
cimetidine, respectively. There were no significant differences between treatment groups. The time to relief of nighttime and daytime
ulcer pain and
antacid consumption were similar in the two groups. The patient's overall subjective assessment was better in the
cimetidine group, but this was not confirmed by physicians' opinions.
Diarrhea was observed in 7 p. 100 of patients treated by
enprostil compared with 5 p. 100 for patients treated by
cimetidine. One
enprostil treated patient withdrew from the trial prematurely because of
abdominal pain. This study demonstrates the efficacy and safety of
enprostil in the treatment of active
duodenal ulcer at the dosage of 35 micrograms twice daily.