Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: A multicenter, randomized, double-dummy study

Francesco Luzza, Andrea Giglio, Enrico Ciliberto, Angelo Belmonte, Cesare Cavaliere, Natale Saccà, Chiara Frandina, Roberto Fiocca, Vincenzo Trimboli, Francesco Pallone

Research output: Contribution to journalArticle

Abstract

Background: The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE®, no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RBC)-based dual therapy regimen, both containing clarithromycin. Objective: This study was undertaken to compare the efficacy of lansoprazole (LAN)-based triple therapy with that of RBC-based dual therapy in H pylori-infected patients with duodenal ulcer. Methods: Patients were randomized to receive either 1 week of triple therapy with LAN 30 mg BID, clarithromycin 500 mg BID, and tinidazole 500 mg BID, followed by 3 weeks of LAN 30 mg BID, or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID, followed by 2 weeks of RBC 400 mg BID. Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination ≥4 weeks after the end of treatment. Duodenal healing and recurrence rates were assessed endoscopically at 8 weeks and 6 months. A per-protocol (PP) analysis was conducted for each efficacy end point. Also conducted were an intent-to-treat (ITT) analysis in which patients with missing data were considered failures, and an observed analysis (OBS), which included patients with an valuable result after treatment, regardless of compliance. Results: One hundred eighty-five patients (126 men, 59 women; age range, 18-76 years; mean age, 43 years) were enrolled and randomized to treatment. In the LAN and RBC groups, respectively, H pylori eradication rates were 92.6%, 93.1%, and 72.8% versus 78.6%, 77.9%, and 64.5% in the PP (P = 0.02), OBS (P = 0.01), and ITT analyses. The corresponding duodenal ulcer healing rates were 98.6%, 98.7%, and 83.7% versus 90.8%, 91.5%, and 81.7%; these differences were not statistically significant. Side effects were mild, occurring in 20.7% of LAN patients and 17.2% of RBC patients. Ulcer recurred in 2 RBC patients. No difference was observed between treatments in terms of the occurrence of gastritis or improvement of symptoms. Conclusion: Based on the results of the PP and OBS analyses, LAN-based triple therapy was superior to RBC-based dual therapy for the eradication of H pylori in patients with duodenal ulcer.

Original languageEnglish
Pages (from-to)761-770
Number of pages10
JournalClinical Therapeutics
Volume23
Issue number5
DOIs
Publication statusPublished - 2001

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Keywords

  • Duodenal ulcer
  • Gastritis
  • Helicobacter pylori
  • Lansoprazole
  • Ranitidine bismuth citrate

ASJC Scopus subject areas

  • Pharmacology

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