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Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial
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Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial
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Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial
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Journal Article
Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial
2011
Overview
Helicobacter pylori is associated with benign and malignant diseases of the upper gastrointestinal tract, and increasing antibiotic resistance has made alternative treatments necessary. Our aim was to assess the efficacy and safety of a new, single-capsule treatment versus the gold standard for
H pylori eradication.
We did a randomised, open-label, non-inferiority, phase 3 trial in 39 sites in Europe, comparing the efficacy and safety of 10 days of quadruple therapy with omeprazole plus a single three-in-one capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline (quadruple therapy) versus 7 days of omeprazole, amoxicillin, and clarithromycin (standard therapy) in adults with recorded
H pylori infection. Patients were randomly assigned treatment according to a predetermined list independently generated by Quintiles Canada (Ville St-Laurent, QC, Canada). Our study was designed as a non-inferiority trial but was powered to detect superiority. Our primary outcome was
H pylori eradication, established by two negative
13C urea breath tests at a minimum of 28 and 56 days after the end of treatment. Our assessment for non-inferiority was in the per-protocol population, with subsequent assessment for superiority in the intention-to-treat population (ie, all participants randomly assigned treatment). This study is registered with
ClinicalTrials.gov, number
NCT00669955.
12 participants were lost to follow-up and 101 were excluded from the per-protocol analysis. In the per-protocol population (n=339), the lower bound of the CI for treatment with quadruple therapy was greater than the pre-established non-inferiority margin of −10% (95% CI 15·1–32·3; p<0·0001). In the intention-to-treat population (n=440), eradication rates were 80% (174 of 218 participants) in the quadruple therapy group versus 55% (123 of 222) in the standard therapy group (p<0·0001). Safety profiles for both treatments were similar; main adverse events were gastrointestinal and CNS disorders.
Quadruple therapy should be considered for first-line treatment in view of the rising prevalence of clarithromycin-resistant
H pylori, especially since quadruple therapy provides superior eradication with similar safety and tolerability to standard therapy.
Axcan Pharma Inc.
Publisher
Elsevier Ltd,Elsevier,Elsevier Limited
Subject
/ Adult
/ adults
/ Amoxicillin - administration & dosage
/ Anti-Bacterial Agents - administration & dosage
/ Anti-Ulcer Agents - administration & dosage
/ Anti-Ulcer Agents - adverse effects
/ Bacterial diseases of the digestive system and abdomen
/ Biological and medical sciences
/ Bismuth
/ Canada
/ Clarithromycin - administration & dosage
/ Clarithromycin - adverse effects
/ Europe
/ Female
/ Helicobacter Infections - diagnosis
/ Helicobacter Infections - drug therapy
/ Humans
/ Male
/ Metronidazole - administration & dosage
/ Metronidazole - adverse effects
/ Omeprazole - administration & dosage
/ Omeprazole - adverse effects
/ Organometallic Compounds - administration & dosage
/ Organometallic Compounds - adverse effects
/ patients
/ Public health. Hygiene-occupational medicine
/ Safety
/ Studies
/ Tablets
/ Tetracycline - administration & dosage
/ Tetracycline - adverse effects
/ Urea
