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
| Autor: | Malfertheiner P, BAZZOLI, FRANCO, Delchier JC, Celiñski K, Giguère M, Rivière M, Mégraud F, for the Pylera Study Group […, Aisene A, Bougnol M, Cassigneul J, Coulom P, Houcke P, Lamarque D, Lamouliatte D, Roques JF, Thevenin A, Ecuer S, Bagnouls G, Helbert T, Andree H, Bouzo H, Brandt W, Cordes HJ, Dettmer A, Juergens H, Rehmann I, Ryschka A, Schaefer T, O'Morain C, Bazzoli F, GASBARRINI, GIOVANNI BATTISTA, Cipolletta L, STANGHELLINI, VINCENZO, Kuipers E, A. de Boer W, Gachowski W, Huk J, Jamrozik Kruk Z, Karnafel W, Kleczkowski D, Kujawski K, Linke K, Petryka R, Serwin D, Wozniak B, Wysokinski A, Castro M, Calleja JL, Calvet X, Gisbert J, Muñoz ED, Bundy C, Orpen I, Mohr DS, Parker I, Cahill T. |
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| Přispěvatelé: | Malfertheiner P, Bazzoli F, Delchier JC, Celiñski K, Giguère M, Rivière M, Mégraud F, for the Pylera Study Group […, Aisene A, Bougnol M, Cassigneul J, Coulom P, Houcke P, Lamarque D, Lamouliatte D, Roques JF, Thevenin A, Ecuer S, Bagnouls G, Helbert T, Andree H, Bouzo H, Brandt W, Cordes HJ, Dettmer A, Juergens H, Rehmann I, Ryschka A, Schaefer T, O'Morain C, Gasbarrini G, Cipolletta L, Stanghellini V, Kuipers E, A de Boer W, Gachowski W, Huk J, Jamrozik-Kruk Z, Karnafel W, Kleczkowski D, Kujawski K, Linke K, Petryka R, Serwin D, Wozniak B, Wysokinski A, Castro M, Calleja JL, Calvet X, Gisbert J, Muñoz ED, Bundy C, Orpen I, Mohr DS, Parker I, Cahill T., …] |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Population Gastroenterology Helicobacter Infections Young Adult Clarithromycin Metronidazole Internal medicine Drug Resistance Bacterial Organometallic Compounds Humans Medicine Bismuth Subcitrate Potassium education Omeprazole Antibacterial agent education.field_of_study biology business.industry Amoxicillin HELICOBACTER PYLORI General Medicine Middle Aged Tetracycline Helicobacter pylori Anti-Ulcer Agents biology.organism_classification Anti-Bacterial Agents Surgery Drug Combinations Breath Tests Tolerability Bismuth Subcitrate Drug Therapy Combination Female eradication therapy business Tablets medicine.drug |
| Popis: | BACKGROUND: 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. METHODS: 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 (13)C 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. FINDINGS: 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 |
| Databáze: | OpenAIRE |
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