COMPARISON OF ONCE-DAILY DOSES OF LANSOPRAZOLE (15, 30, AND 60 MG) AND PLACEBO IN PATIENTS WITH GASTRIC-ULCER

Objectives: A multicenter, double-blind study was conducted in 268 pat ients to compare the safety and efficacy of 15, 30, and 60 mg of lanso prazole and placebo in the treatment of gastric ulcer. Methods: The st udy included an 8-wk treatment period to assess healing and a 6-month posttreatment period to evaluate ulcer recurrence. Endoscopies were pe rformed, GI symptoms and antacid use were assessed, and safety evaluat ions were conducted, including serum gastrin and biopsies of the lesio ns and the greater curvature of the stomach. Results: At week 4, heali ng rates were significantly higher with lansoprazole 15 and 30 mg (64. 6 and 58.1%, respectively) compared with placebo (37.5%). By week 8, h ealing rates were 76.7%, with placebo, 92.2% with 15 mg of lansoprazol e, 96.8% with 30 mg, and 93.2% with 60 mg of lansoprazole (p < 0.05). The drug was well tolerated, with no significant differences from plac ebo in the incidence of adverse events. Fasting serum gastrin increase d in all lansoprazole groups, reaching a plateau by week 2 and returni ng to baseline levels by month 1 posttreatment. No significant increas e in Grimelius-positive cells or inflammation was evident. All but two patients had normal gastric morphology evaluated by Solcia classifica tion. Conclusions: Lansoprazole, 15, 30, and 60 mg, administered once daily before eating, healed gastric ulcers to an approximately equal d egree, and all were significantly better than placebo.