Dl. Avner et al., A COMPARISON OF 3 DOSES OF LANSOPRAZOLE (15, 30 AND 60 MG) AND PLACEBO IN THE TREATMENT OF DUODENAL-ULCER, Alimentary pharmacology & therapeutics, 9(5), 1995, pp. 521-528
Background: Lansoprazole is a new proton pump inhibitor for the treatm
ent of peptic ulcer disease. Methods: A double-blind, multicentre stud
y was undertaken in 296 patients with endoscopically proven duodenal u
lcer to compare the efficacy and safety of lansoprazole 15, 30 or 60 m
g with placebo. Ulcer healing was documented by endoscopy at 2 and 4 w
eeks; patients whose ulcers healed after 4 weeks were followed for up
to 6 months post-treatment. Results: Four-week healing rates of 89.4%,
91.7% and 89.9% were obtained with lansoprazole 15, 30 and 60 mg, res
pectively, compared with 46.1% on placebo (P < 0.001). All three doses
of lansoprazole produced rapid symptom relief, although patients taki
ng 60 mg lansoprazole required fewer antacids than did those taking 15
mg. At 6 months, the percentages of patients healed were 45.3%, 40.0%
and 38.4% in the lansoprazole 15, 30 and 60 mg dosage groups, respect
ively, and 25.3% for the placebo group. No significant adverse events
were documented during the period of this trial. Conclusion: Lansopraz
ole is an effective and safe treatment for duodenal ulcer and the 15 m
g dose is as effective as 30 or 60 mg.