Lansoprazole 30 mg or 60 mg combined with two antibiotics (amoxicillin andclarithromycin) to eradicate Helicobacter pylori in patients with duodenalulcer

Objective - The primary objective of the present study was to evaluate the efficacy of 30 and 60 mg of lansoprazole administered in combination with t wo antibiotics for 7 or 10 days in eradicating Helicobacter pylori in duode nal ulcer patients. Methods - This multicenter double-blind study randomized for the lansoprazo le dose was carried out by 325 gastroenterologists. The H. pylori positive diagnosis was based on three antral biopsies (one for rapid urease test and two for histological examination). Eradication was checked by a C-13-urea breath test. Patients were given 30 or 60 mg of lansoprazole with 2 g of am oxicillin and 1 g of clarithromycin for 10 days or 7 days, followed by 30 m g of lansoprazole daily for 18 or 27 days, i.e. the total duration of antis ecretory 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 we re significantly higher in the group receiving 60 mg of lansoprazole than i n 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 gr oup, the rates (95% confidence intervals) in the 7-day and 10-day sub-group s 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 - 9 5.4), respectively. With either lansoprazole dose, the eradication rates se emed higher when therapy was administered for 10 days. Conclusion - The double dose of lansoprazole optimizes H. pylori eradicatio n rates. The highest eradication rates were obtained after lo days of thera py. Additional studies should be carr out to determine the optimal duration of triple therapy For eradicating H. pylori.