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

• Published in: Clinical therapeutics Vol. 23; no. 5; pp. 761 - 770
• Main Authors: Luzza, Francesco, Giglio, Andrea, Ciliberto, Enrico, Belmonte, Angelo, Cavaliere, Cesare, Saccá, Natale, Frandina, Chiara, Fiocca, Roberto, Trimboli, Vincenzo, Pallone, Francesco
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 01.05.2001; Excerpta Medica
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Anti-Ulcer Agents - adverse effects; Anti-Ulcer Agents - therapeutic use; Biological and medical sciences; Bismuth - adverse effects; Bismuth - therapeutic use; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Digestive system; Double-Blind Method; Drug Therapy, Combination; duodenal ulcer; Duodenal Ulcer - drug therapy; Dyspepsia; Female; gastritis; Headache - chemically induced; Helicobacter Infections - drug therapy; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; Lansoprazole; Male; Medical sciences; Middle Aged; Omeprazole - adverse effects; Omeprazole - analogs & derivatives; Omeprazole - therapeutic use; Pharmacology. Drug treatments; Pruritus - chemically induced; Ranitidine - adverse effects; Ranitidine - analogs & derivatives; Ranitidine - therapeutic use; ranitidine bismuth citrate; Recurrence; Taste Disorders - chemically induced; Tinidazole - adverse effects; Tinidazole - therapeutic use; Treatment Outcome; ranitidine bismuth citrate; lansoprazole; Helicobacter pylori; gastritis; duodenal ulcer; Clarithromycin; Spirillaceae; Antiulcer agent; Eradication; Proton pump inhibitor; Bacteria; Intestinal disease; Ulcer; Antagonist; Human; Drug combination; Spirillales; Duodenum; Macrolide; Infection; Antibiotic; Chemotherapy; Treatment; Benzimidazole derivatives; Ranitidine; Bacteriosis; Digestive diseases; Antibacterial agent; Comparative study; Lansoprazole; H2 Histamine receptor
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(01)80025-4

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 evaluable 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.