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Tytuł pozycji:

Rationale and design of the VISION study: a randomized, open-label study to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive esophagitis

Tytuł :
Rationale and design of the VISION study: a randomized, open-label study to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive esophagitis
Autorzy :
Uemura N
Kinoshita Y
Haruma K
Yao T
Kushima R
Kanoo T
Pokaż więcej
Temat :
erosive esophagitis
gastric mucosa
lansoprazole
long-term safety
vonoprazan
Diseases of the digestive system. Gastroenterology
RC799-869
Źródło :
Clinical and Experimental Gastroenterology, Vol Volume 11, Pp 51-56 (2018)
Wydawca :
Dove Medical Press, 2018.
Rok publikacji :
2018
Kolekcja :
LCC:Diseases of the digestive system. Gastroenterology
Typ dokumentu :
article
Opis pliku :
electronic resource
Język :
English
ISSN :
1178-7023
Relacje :
https://www.dovepress.com/rationale-and-design-of-the-vision-study-a-randomized-open-label-study-peer-reviewed-article-CEG; https://doaj.org/toc/1178-7023
Dostęp URL :
https://doaj.org/article/36eec9296f5049639d2a4a32c43f20dd
Numer akcesji :
edsdoj.36eec9296f5049639d2a4a32c43f20dd
Czasopismo naukowe
Naomi Uemura,1 Yoshikazu Kinoshita,2 Ken Haruma,3 Takashi Yao,4 Ryoji Kushima,5 Tatsuhiro Kanoo6 1Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Chiba, Japan; 2Department of Gastroenterology and Hepatology, Faculty of Medicine, Shimane University, Shimane, Japan; 3Department of General Internal Medicine 2, Kawasaki Medical School General Medical Center, Okayama, Japan; 4Department of Human Pathology, Juntendo University Graduate School of Medicine, Tokyo, Japan; 5Department of Clinical Laboratory Medicine, Shiga University of Medical Science Hospital, Shiga, Japan; 6Takeda Pharmaceutical Co., Ltd, Osaka, Japan Abstract: Erosive esophagitis (EE) occurs when the epithelial mucosa is damaged due to gastric acid reflux, and the incidence of this disease is increasing in Japan due to changes in diet and lifestyle. The condition can be treated using proton pump inhibitors (PPIs) that act by irreversibly blocking the H+,K+-ATPase responsible for acid secretion. Vonoprazan is a K+ competitive channel inhibitor, which reversibly and potently inhibits gastric acid secretion. However, long-term data on vonoprazan use are limited. The aim of the VISION trial is to investigate the long-term efficacy and safety of vonoprazan in comparison with the PPI lansoprazole. This randomized, multicenter, 5-year, open-label study has a planned recruitment of 195 participants (2:1 allocation vonoprazan:lansoprazole) from 33 sites in Japan. The study comprises an 8-week “healing” phase (vonoprazan 20 mg or lansoprazole 30 mg p.o.) and a 260-week “maintenance” phase (vonoprazan 10 mg or lansoprazole 15 mg). Safety populations in both phases are defined as participants who receive at least one dose of the study or control drug in the healing and maintenance phases, respectively. The full analysis set in both phases is defined as participants who are randomized and receive at least one dose of the study or control drug in the healing and maintenance phases, respectively. The primary endpoint of the study is the histopathological evaluation of gastric mucosa for the presence of neoplastic alteration of gastric mucosal epithelial cells. Secondary efficacy endpoints include endoscopic EE recurrence rate and EE healing rate, and secondary safety endpoints include incidence of adverse events (coded using MedDRA terminology) and endoscopic evaluation of malignant changes in the gastric mucosa. Patient recruitment started in March 2016 and is now complete. The estimated study completion date is February 2022. Keywords: erosive esophagitis, gastric mucosa, lansoprazole, long-term safety, vonoprazan, K+ competitive channel inhibitor, neoplasia

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