Gb. Porro et al., OMEPRAZOLE AND SUCRALFATE IN THE TREATMENT OF NSAID-INDUCED GASTRIC AND DUODENAL-ULCER, Alimentary pharmacology & therapeutics, 12(4), 1998, pp. 355-360
Aim: To establish the healing efficacy of two drugs, omeprazole and su
cralfate, when given to patients who had developed gastric or duodenal
ulcer while undergoing chronic treatment with non-steroidal antiinfla
mmatory drugs (NSAIDs). Methods: Ninety-eight patients with arthritis
or arthrosis and NSAID-related gastric or duodenal ulcer were admitted
to the endoscopic, single-blind study. They were randomized to receiv
e either omeprazole 20 mg o.m. or sucralfate 2 g b.d. for 4-8 weeks. T
he patients continued to receive the same NSAID during the trial. Uppe
r gastrointestinal endoscopy was performed at entry and after 4 or 8 w
eeks. Results: Eighty-eight patients completed the 4-week study, but o
nly 81 were available for final analysis at 8 weeks. Omeprazole was si
gnificantly superior to sucralfate in inducing gastric ulcer healing a
fter both 4 (87 vs, 52%, P = 0.007) and 8 weeks (100 vs. 82%, P = 0.04
), No statistically significant difference in duodenal ulcer healing r
ates emerged between the two groups either at 4 (79 vs. 55%) or 8 week
s (95 vs. 73%). The healing rates in patients with combined gastric an
d duodenal ulcer were 67 vs, 33% after 4 weeks and 67 vs. 67% after 8
weeks of treatment, The percentages of asymptomatic patients were simi
lar in the two treatment groups both at 4 (70 vs, 73%) and 8 weeks (70
vs, 75%). H. pylori infection did not influence healing rates, but si
gnificantly more H. pylori-positive patients healed with omeprazole. C
onclusions: The results of this study show that omeprazole is superior
to sucralfate in healing NSAID-induced gastroduodenal ulcer in patien
ts who continue to take anti-inflammatory drugs, The good results obse
rved were unrelated to H. pylori status.