Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study)
Rattachement africain : jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: Vonoprazan (V), a potassium-competitive acid blocker, has a more durable acid-inhibitory effect as compared with standard-dose proton pump inhibitors (PPIs) but has not been compared with 2-4 times higher daily PPI doses administered in two divided doses. AIMS: To evaluate the acid-inhibitory effect of V 10/20 mg once-daily (OD; V10/V20) vs rabeprazole (R) 10/20 mg twice-daily (BID; R20/R40) in healthy Japanese volunteers. METHODS: This multicentre, randomised, open-label, two-period, crossover study compared V10 or V20 vs R20, or V20 vs R40 using three cohorts of 10 healthy Japanese adults. Within each cohort, subjects were randomised to receive V or R for 7 days and, following a washout period ≥7 days, the other treatment for 7 days. On day 6 of each period, 24-hours multichannel gastric impedance-pH monitoring was performed. Percent times pH ≥ 3, ≥4 and ≥5 (pH 3, 4 and 5 holding time ratios [HTRs]) in 24 hours were evaluated as primary pharmacodynamic endpoints. RESULTS: Acid-inhibitory effect (24-hours pH 3 HTR) of V20 was greater than those of R20 (91.0% vs 65.3%; P = .0049) and R40 (98.5% vs 85.9%; P = .0073). Similar results were obtained for 24-hours pH 4 and 5 HTRs. V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40. One subject (20%) developed diarrhoea while receiving R40 which was considered treatment-related. CONCLUSIONS: Compared with 2-4 times the standard daily dose of R, V20 exerts a more potent and durable acid-inhibitory effect. Trial identifier: UMIN000022198 (www.umin.ac.jp/ctr/index.htm).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study)
- Date Crossref
- 28/01/2020
- Éditeur
- Wiley
- 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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Osaka Medical and Pharmaceutical University pays non établi dans la noticeUniversité ou école supérieure
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Hamamatsu University School of Medicine Center for Clinical Research pays non établi dans la noticeUniversité ou école supérieure
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Osaka City University Department of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Shiga University of Medical Science Hospital Division of Digestive Endoscopy pays non établi dans la noticeÉtablissement de santé
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Aichi Medical University Department of Gastroenterology pays non établi dans la noticeUniversité ou école supérieure
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Gunma University Hospital Department of Endoscopy and Endoscopic Surgery pays non établi dans la noticeÉtablissement de santé
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Okayama University Department of Gastroenterology and Hepatology pays non établi dans la noticeUniversité ou école supérieure
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Saga Medical School Hospital pays non établi dans la noticeÉtablissement de santé
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Endoscopic Center Osaka Medical College Hospital Takatsuki Japan Endoscopic Center pays non établi dans la noticeUniversité ou école supérieure
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Second Department of Internal Medicine Osaka Medical College Takatsuki Japan pays non établi dans la noticeUniversité ou école supérieure
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Department of Internal Medicine Saga Medical School Saga Japan pays non établi dans la noticeInstitution
Osaka Medical and Pharmaceutical University, Center for Clinical Research — Hamamatsu University School of Medicine et Department of Gastroenterology — Osaka City University, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.