Background: Lansoprazole is a potent antisecretory drug also possessing anti-Helicobacter pylori activity in vitro. It is a candidate drug for combination regimens with antibiotics for treating H. pylori infections.
Methods: In a semiblind study, 65 patients with duodenal and/or gastric ulcer and pathologic 14C urea breath test results were treated with either 60 mg lansoprazole every morning only for 14 days or combined with 500 mg amoxicillin oral suspension four times daily between meals, given for 11 days. Endoscopy and breath test were repeated after 6 weeks and 6 months. Patients with unhealed ulcers were withdrawn.
Results: Eradication of H. pylori infection was attained in 46% of patients receiving lansoprazole and amoxicillin but in no patient receiving lansoprazole alone. Ulcers healed significantly more often in those who were H. pylori-negative (18 of 19 (95%)) than in those who were H. pylori-positive (20 of 41 (49%)). Adverse events, particularly stomatitis/sore throat and diarrhea, occurred significantly more often when amoxicillin was combined with lansoprazole.
Conclusions: Lansoprazole eradicated H. pylori infection only when combined with amoxicillin. Eradication rates in this study are hardly acceptable, and further studies are necessary to define optimal doses and duration of treatment. Using amoxicillin as an oral suspension may not be of any substantial benefit and may cause stomatitis and sore throat.