A TRIAL OF LANSOPRAZOLE IN REFRACTORY GASTRIC-ULCER

Background: The proton-pump inhibitor, lansoprazole, a more potent gas tric acid inhibitor with a longer action than H-2-receptor antagonists , should heal refractory gastric ulcers more effectively. Methods: Lan soprazole's efficacy in healing refractory gastric ulcer(s) (i.e. afte r 6 weeks of treatment with H-2-receptor antagonists, antacids or sucr alfate at recommended dosages, and/or a relapse within 1 year of docum ented gastric ulcer), was compared by a two-dose regimen in a four-cen tre, randomized, parallel group study. One hundred and eighteen patien ts (59 per group) with an endoscopically confirmed gastric ulcer great er than or equal to 3 mm, received lansoprazole 30 or 60 mg daily. We assessed efficacy endoscopically at 4 and 8 weeks, and again after doc umented healing during a maintenance phase of lansoprazole 30 mg/day a t 2 and 4 months. Results: Demographic and anthropometric data were co mparable. Healing rates at 4 weeks were 63% (30 mg) vs. 66% (60 mg) (9 5% CI, -14 to 21%) and cumulatively at 8 weeks, 83% (30 mg) vs. 81% (6 0 mg) (95% CI, -12 to 16%). Two and 4 months after documented healing, 86% and 78% of intention-to-treat patients remained in remission. Con clusion: Lansoprazole 30 or 60 mg/day appear equally effective in heal ing refractory gastric ulcers, while maintenance therapy of 30 mg/day effectively prevented an ulcer relapse.