Open-label study of a regimen consisting of 1 week of lansoprazole, clarithromycin, and amoxicillin followed by 3 weeks of lansoprazole in healing peptic ulcer and eradicating Helicobacter pylori

Abstract

Objective: The aim of the study was to assess the efficacy of a regimen consisting of 1 week of low-dose triple therapy with lansoprazole, amoxicillin, and clarithromycin followed by lansoprazole alone for an additional 3 weeks in the eradication of Helicobacter pylori and the healing of peptic ulcer. Methods: Patients aged ≥16 years with active peptic ulcer diagnosed by endoscopy and H pylori infection were eligible for this prospective, open-label, 3-center study. A triple-drug regimen was used that consisted of lansoprazole 30 mg once daily, amoxicillin 1 g BID, and clarithromycin 250 mg BID for 7 days. Ulcer healing and H pylori eradication were assessed endoscopically 8 to 9 weeks after the start of treatment. H pylori was determined to be eradicated if both histologic examination and rapid urease testing (4 biopsy samples, antrum [2] and body [2]) were negative. Results: Fifty-five patients who tested positive for H pylori, 49 with duodenal ulcer (DU) and 6 with gastric ulcer (GU), aged 16 to 78 years, were enrolled in the study. Ten patients were lost to follow-up and 1 withdrew from the study because of side effects; 44 patients were included in the per-protocol analyses. H pylori was eradicated in 34 patients, 62% (95% CI, 0.477-0.746) and 77% (95% CI, 0.662-0.885) in the intent-to-treat and per protocol analyses, respectively. Ulcers were healed in a total of 38 patients (34 DU, 4 GU), 69% in the intent-to-treat population (95% CI, 0.552-0.809) and 86% in the per-protocol population (95% CI, 0.727-0.948). In patients with DU, the rate of healing was 69% in the intent-to-treat analysis (95% CI, 0.546-0.817) and 89% in the per-protocol analysis (95% CI, 0.752-0.971). Conclusions: One week of therapy with lansoprazole 30 mg once daily, amoxicillin 1 g BID, and clarithromycin 250 mg BID, followed by 3 weeks of treatment with lansoprazole 30 mg once daily, effectively healed peptic ulcer but was only moderately effective in eradicating H pylori.