Seven-day vonoprazan and low-dose amoxicillin dual therapy as first-line Helicobacter pylori treatment: a multicentre randomised trial in Japan
Rattachement africain : jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Objective To date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for Helicobacter pylori treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line H. pylori treatment, and compared this with vonoprazan-based triple therapy. Design This prospective, randomised clinical trial was performed at seven Japanese institutions. Patients with H. pylori –positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex, H. pylori antimicrobial resistance and institution. Eradication success was evaluated by 13 C-urea breath test at least 4 weeks after treatment. Results Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups. Conclusion The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance. Trial registration number UMIN000034140.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Seven-day vonoprazan and low-dose amoxicillin dual therapy as first-line <i>Helicobacter pylori</i> treatment: a multicentre randomised trial in Japan
- Date Crossref
- 08/01/2020
- Éditeur
- BMJ
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Nihon University Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Yuri Kumiai General Hospital Department of Gastroenterology pays non établi dans la noticeOrganisation à but non lucratif
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Osaki Citizen Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Sendai City Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Yamanashi Research Institute pays non établi dans la noticeInstitution
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Saitama Municipal Hospital pays non établi dans la noticeÉtablissement de santé
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Yamanashi Koseiren Health Care Center pays non établi dans la noticeInstitution
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Chichibu Municipal Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Fukaya Red Cross Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
Department of Medicine — Nihon University, Department of Gastroenterology — Yuri Kumiai General Hospital et Department of Gastroenterology — Osaki Citizen Hospital, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.