[Treatment of Helicobacter pylori infection with lansoprazole 30 mg or 60 mg combined with two antibiotics for duodenal ulcers].

OBJECTIVE

The primary objective of the present study was to evaluate the efficacy of 30 and 60 mg of lansoprazole administered in combination with two antibiotics for 7 or 10 days in eradicating Helicobacter pylori in duodenal ulcer patients.

METHODS

This multicenter double-blind study randomized for the lansoprazole dose was carried out by 325 gastroenterologists. The H. pylori-positive diagnosis was based on three antral biopsies (one for a rapid urease test and two for histological examination). Eradication was checked by a (13) C-urea breath test. Patients were given 30 or 60 mg of lansoprazole with 2 g of amoxicillin and 1 g of clarithromycin for 10 days or 7 days, followed by 30 mg of lansoprazole daily for 18 or 21 days, i.e. the total duration of antisecretory therapy was 28 days.

RESULTS

Out of the 665 patients included, 620 were analyzed on the intent-to-treat basis and 567 on the per protocol basis. The eradication rates were significantly higher in the group receiving 60 mg of lansoprazole than in the 30 mg group in both the intent-to-treat analysis (P=0.003) and the per protocol analysis (P=0.006). In the intent-to-treat analysis 60 mg group, the rates (95% confidence intervals) in the 7-day and 10-day sub-groups were 82.5 (CI: 75.2 - 89.8) and 86.8% (CI: 82.2 - 91.4), respectively, and in the per protocol analysis 84.2 (CI: 76.9 - 91.5) and 91.5% (CI: 87.6 - 95.4), respectively. With either lansoprazole dose, the eradication rates seemed higher when therapy was administered for 10 days.

CONCLUSION

The double dose of lansoprazole optimizes H. pylori eradication rates. The highest eradication rates were obtained after 10 days of therapy. Additional studies should be carried out to determine the optimal duration of triple therapy for eradicating H. pylori.