Double-blind comparison of lansoprazole 15 mg, lansoprazole 30 mg and placebo as maintenance therapy in patients with healed duodenal ulcers resistant to H-2-receptor antagonists

Background: Maintenance antisecretory therapy is often used to prevent duod enal ulcer recurrence and control symptoms. This study compared the efficac y and safety of lansoprazole 15 mg and 30 mg daily with placebo in preventi ng ulcer recurrence in patients with a recent history of duodenal ulcer dis ease. Methods: Fifty-six patients were treated with either lansoprazole 15 mg, 30 mg or placebo o.m. Results: Within 1 month of study initiation. 27% (four out of 15) of placeb o-treated patients experienced ulcer recurrence as compared to 13% (two out of 15) and 6% (one out of 18) of lansoprazole 15 mg and 30 mg treated pati ents, respectively. Median time to first ulcer recurrence was > 12 months i n lansoprazole patients. At Month 12, significantly (P < 0.001) more lansop razole 15 mg patients (70%) and lansoprazole 30 mg patients (85%) remained healed. Eighty-two per cent of lansoprazole 15 mg and 76% of lansoprazole 3 0 mg patients remained asymptomatic during the entire study period. All pla cebo patients became symptomatic, experienced ulcer recurrence, or withdrew from the study by month six. The incidence of adverse events was comparabl e among the three treatment groups. Conclusions: Lansoprazole safely and effectively reduces duodenal ulcer rec urrence and ulcer-related symptoms.