1. Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area
- Author
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Sotirios D. Georgopoulos, Spyros Michopoulos, Kalliopi Petraki, Kostantinos Zografos, Beatrice Martinez-Gonzales, Andreas Mentis, Panagiotis Kasapidis, Charikleia Spiliadi, Elias Grivas, Fotini Laoudi, Elias Xirouchakis, Evanthia Zampeli, Maria Sotiropoulou, Dionysios Sgouras, Paleo Faliro Clinic [Athens], Laboratoire de microbiologie médicale = Laboratory of Medical Microbiology [Athènes], Institut Pasteur Hellénique, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Alexandra hospital [Athens, Greece], Central Clinic of Athens, Metropolitan Hospital [Athens], and This study was in part funded by the Hellenic Society of Gastroenterology (grant number 4704/2011).
- Subjects
Male ,Metronidazole resistance ,Biopsy ,MESH: Helicobacter Infections/pathology ,MESH: Pyloric Antrum/pathology ,MESH: Anti-Bacterial Agents/administration & dosage ,Gastroenterology ,law.invention ,Esomeprazole ,Clarithromycin resistance ,MESH: Biopsy ,0302 clinical medicine ,Randomized controlled trial ,law ,Clarithromycin ,Pyloric Antrum ,Urea ,H. pylori treatment ,MESH: Aged ,MESH: Amoxicillin/administration & dosage ,MESH: Peptic Ulcer/drug therapy ,Carbon Isotopes ,MESH: Dyspepsia/drug therapy ,MESH: Middle Aged ,biology ,MESH: Clarithromycin/administration & dosage ,MESH: Helicobacter Infections/metabolism ,Middle Aged ,Anti-Bacterial Agents ,3. Good health ,MESH: Urea/metabolism ,Concomitant treatment ,Breath Tests ,030220 oncology & carcinogenesis ,Drug Therapy, Combination ,Female ,030211 gastroenterology & hepatology ,medicine.drug ,Adult ,Peptic Ulcer ,medicine.medical_specialty ,MESH: Dyspepsia/microbiology ,Helicobacter Infections ,MESH: Peptic Ulcer/microbiology ,03 medical and health sciences ,Metronidazole ,Internal medicine ,Drug Resistance, Bacterial ,MESH: Drug Resistance, Bacterial ,[SDV.MHEP.AHA]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO] ,Internal Medicine ,medicine ,Humans ,Sequential treatment ,MESH: Proton Pump Inhibitors/administration & dosage ,Dyspepsia ,Aged ,MESH: Helicobacter Infections/drug therapy ,MESH: Humans ,Intention-to-treat analysis ,Helicobacter pylori ,business.industry ,Amoxicillin ,MESH: Carbon Isotopes ,Proton Pump Inhibitors ,MESH: Adult ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,biology.organism_classification ,[SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology ,MESH: Male ,Surgery ,First line ,MESH: Breath Tests ,MESH: Drug Therapy, Combination ,MESH: Esomeprazole/administration & dosage ,MESH: Metronidazole/administration & dosage ,Concomitant ,MESH: Helicobacter pylori ,business ,MESH: Female - Abstract
This article has been previously presented in a meeting and published as an abstract: Georgopoulos SD, Xirouchakis E, Zampeli E, et al. A randomized study comparing 10 days concomitant and sequential treatments for the eradication of Helicobacter pylori, in a high clarithromycin resistance area. Gastroenterology 2014;146:S397.; International audience; BACKGROUND: Currently only a few studies compare sequential and concomitant non-bismuth Helicobacter pylori therapies referring to high antibiotic resistance populations.MATERIALS AND METHODS: This multicenter prospective randomized clinical trial included 353 H. pylori positive, treatment naïve, patients. All patients had positive CLO-test and/or histology and culture. They received sequential (esomeprazole 40mg, amoxicillin 1g/bid for 5days, followed by 5days of esomeprazole 40mg, clarithromycin 500mg and metronidazole 500mg bid), or concomitant treatment (all drugs taken concomitantly bid for 10days). Eradication was confirmed by (13)C-urea breath test or histology 4-6weeks after treatment. Adverse events and adherence were evaluated.RESULTS: Allocated to concomitant were 175 (72F/103M, mean 52.3years, 38.3% smokers, 25.7% ulcer disease) and 178 (87F/91M, mean 52years, 31% smokers, 19.1% ulcer disease) patients to sequential treatment. There were 303/353 (85.8%) positive cultures, with the following resistances: 34% metronidazole, 27.7% clarithromycin, and 7.9% dual. Eradication rates were, respectively, 89.1% (156/175) vs. 78.7% (140/178) by intention to treat (p=0.01, 95% CI=2.7-18) and 93.4%(156/167) vs. 82.8% (140/169) per protocol (p=0.004, 95% CI=3.6-17.6). Overall, adherence was (98.9%, 95% CI=97-100). Eradication rates according to resistance were the following: dual susceptible strains 67/69 (97.1%), 62/67 (92%) (p=0.4), metronidazole single resistant 38/39 (97.4%), 31/39 (79.5%) (p=0.03, 95% CI=3.5-33), clarithromycin single resistant 25/28 (89.3%), 26/31 (83.9%) (p=0.8), and dual resistant 9/12 (75%), 4/11 (36.4%) (p=0.1) for concomitant and sequential regimens, respectively. Side effects were comparable among regimens, except from diarrhea being more frequent among patients treated with concomitant treatment.CONCLUSIONS: Concomitant treatment eradication rate overcomes 90% per protocol and has a significant advantage over sequential therapy. This is probably due to its better efficacy on metronidazole resistant strains. Both regimens were well tolerated and safe.
- Published
- 2016