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
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 (R...
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Published in | Clinical therapeutics Vol. 23; no. 5; pp. 761 - 770 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Belle Mead, NJ
EM Inc USA
01.05.2001
Excerpta Medica |
Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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ISSN: | 0149-2918 1879-114X |
DOI: | 10.1016/S0149-2918(01)80025-4 |