Vonoprazan as a Long-term Maintenance Treatment for Erosive Esophagitis: VISION, a 5-Year, Randomized, Open-label Study
Rattachement africain : jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND & AIMS: Acid secretion inhibitors are associated with hypergastrinemia, which can lead to gastric mucosal changes. Potassium-competitive acid blockers, such as vonoprazan, are more potent than proton pump inhibitors, but long-term safety data are lacking. METHODS: In this phase IV, randomized trial, patients with erosive esophagitis (EE) received induction therapy (once daily vonoprazan 20 mg or lansoprazole 30 mg; ≤8 weeks). Those with healed EE received maintenance therapy (once daily vonoprazan 10 mg or lansoprazole 15 mg) for 260 weeks (2:1). The primary endpoint was the proportion of patients with malignant epithelial cell alterations, parietal cell hyperplasia, foveolar hyperplasia, enterochromaffin-like (ECL) cell hyperplasia, and G-cell hyperplasia. RESULTS: Overall, 202/208 patients (vonoprazan, n = 139; lansoprazole, n = 69) achieved healed EE and received maintenance therapy. No malignant alterations or gastric neuroendocrine tumors (NETs) were observed; there was 1 adenoma in each group. At week 260, significantly more patients taking vonoprazan vs lansoprazole had parietal cell hyperplasia (97.1% vs 86.5%) and foveolar hyperplasia (14.7% vs 1.9%); proportions of patients with ECL cell hyperplasia (4.9% vs 7.7%) and G-cell hyperplasia (85.3% vs 76.9%) were similar. Median serum gastrin levels were higher with vonoprazan treatment vs lansoprazole (625 pg/mL vs 200 pg/mL). Incidences of adverse events were comparable for both treatments. CONCLUSIONS: The exploratory VISION study assessed the safety profile of vonoprazan and lansoprazole over 5 years in Japanese patients with healed EE. Although gastrin concentration, parietal cell hyperplasia, and foveolar hyperplasia were higher in the vonoprazan group, there was no increased risk of malignant epithelial cell alterations and gastric NETs. (ClinicalTrials.gov, NCT02679508).
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 ; titre concordant.
- Titre Crossref
- Vonoprazan as a Long-term Maintenance Treatment for Erosive Esophagitis: VISION, a 5-Year, Randomized, Open-label Study
- Date Crossref
- 01/04/2025
- Éditeur
- Elsevier BV
- 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
-
National Center for Global Health and Medicine pays non établi dans la noticeÉtablissement de santé
-
Himeji Medical Center pays non établi dans la noticeÉtablissement de santé
-
Hyogo Prefectural Harima-Himeji General Medical Center General Internal Medicine pays non établi dans la noticeÉtablissement de santé
-
Kawasaki Medical School Department of General Internal Medicine 2 pays non établi dans la noticeUniversité ou école supérieure
-
Shiga University of Medical Science Hospital Department of Clinical Laboratory Medicine pays non établi dans la noticeÉtablissement de santé
-
Juntendo University Department of Human Pathology pays non établi dans la noticeUniversité ou école supérieure
-
Shiga Medical Center for Adults pays non établi dans la noticeÉtablissement de santé
-
Takeda (Japan) pays non établi dans la noticeEntreprise
-
Kohnodai Hospital Department of Gastroenterology and Hepatology pays non établi dans la noticeÉtablissement de santé
-
Department of Gastroenterology and Hepatology pays non établi dans la noticeInstitution
-
Aoyama Medical Clinic Gastrointestinal Endoscopy and Inflammatory Bowel Disease Center pays non établi dans la noticeÉtablissement de santé
-
Takeda Pharmaceutical Company Ltd pays non établi dans la noticeEntreprise
National Center for Global Health and Medicine, Himeji Medical Center et General Internal Medicine — Hyogo Prefectural Harima-Himeji General Medical Center, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.