Enprostil, a
prostaglandin E2 analogue, is effective in healing acute
duodenal ulcer but its value in preventing recurrence, when given daily for maintenance
therapy, is uncertain. In this three-centre study we compared
enprostil and
ranitidine maintenance
therapy; the latter is known to reduce
duodenal ulcer relapse rates. Patients whose
duodenal ulcers had been healed by treatment with an H2-receptor antagonist were randomized to receive single-blind treatment with either 35 micrograms
enprostil (n = 64) or 150 mg
ranitidine (n = 64) at bedtime for periods of up to 1 year. Endoscopy was routinely performed at 3 months at one centre, and at 6 and 12 months at all three centres, or whenever
ulcer symptoms recurred. Clinical assessment and laboratory investigations were performed every 3 months. Relapse, defined as recurrent
ulcer with or without
pain, or erosions with
pain, was significantly greater in patients on
enprostil, the comparative rates at 3, 6 and 12 months were:
enprostil 23, 31 and 36%
ranitidine 6, 12 and 17% (P = 0.013; P = 0.03 and P = 0.03, respectively). Thirty-one patients reported adverse events, the most common being
headache (
enprostil = 6,
ranitidine = 2) and mild diarrhoea (
enprostil = 6,
ranitidine = 0). Four patients on
enprostil were withdrawn for adverse events, although none terminated because of diarrhoea. There were no clinically significant changes in haematology or biochemistry.
Enprostil may reduce
duodenal ulcer relapse but at a dose of 35 micrograms nightly, it is less effective than 150 mg
ranitidine nightly.