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The aim of this study was to assess the long-term safety of vonoprazan for maintenance treatment of healed erosive oesophagitis versus lansoprazole.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients with endoscopically diagnosed erosive oesophagitis were randomised 2:1 to once-daily vonoprazan 20\u00a0mg or lansoprazole 30\u00a0mg, for a 4- to 8-week healing phase. Patients with endoscopically confirmed healing entered a 260-week maintenance phase with a once-daily starting dose of vonoprazan 10\u00a0mg or lansoprazole 15\u00a0mg. Primary endpoint was change in gastric mucosal histopathology.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of 208 patients (vonoprazan, <jats:italic>n<\/jats:italic>\u2009=\u2009139; lansoprazole, <jats:italic>n<\/jats:italic>\u2009=\u200969) entering the healing phase, 202 entered the maintenance phase (vonoprazan, <jats:italic>n<\/jats:italic>\u2009=\u2009135; lansoprazole, <jats:italic>n<\/jats:italic>\u2009=\u200967). At 3\u00a0years, 109 vonoprazan-treated and 58 lansoprazole-treated patients remained on treatment. Histopathological evaluation of gastric mucosa showed that hyperplasia of parietal, foveolar and G cells was more common with vonoprazan than lansoprazole at week 156 of the maintenance phase. There was no marked increase in the occurrence of parietal, foveolar and G cell hyperplasia among patients in the vonoprazan group from week 48 to week 156. Histopathological evaluation of the gastric mucosa also showed no neoplastic changes in either group. No new safety issues were identified.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>In this interim analysis of VISION, no new safety concerns were identified in Japanese patients with healed erosive oesophagitis receiving vonoprazan or lansoprazole as maintenance treatment for 3\u00a0years. (CT.gov identifier: NCT02679508; JapicCTI-163153; Japan Registry of Clinical Trials: jRCTs031180040).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12876-023-02772-w","type":"journal-article","created":{"date-parts":[[2023,5,1]],"date-time":"2023-05-01T16:01:26Z","timestamp":1682956886000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Randomised clinical trial: 3-year interim analysis results of the VISION trial to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagitis"],"prefix":"10.1186","volume":"23","author":[{"given":"Ken","family":"Haruma","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshikazu","family":"Kinoshita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Yao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryoji","family":"Kushima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junichi","family":"Akiyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuo","family":"Aoyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuhiro","family":"Kanoo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kouji","family":"Miyata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi","family":"Kusumoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi","family":"Uemura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,5,1]]},"reference":[{"issue":"1","key":"2772_CR1","doi-asserted-by":"publisher","first-page":"231","DOI":"10.1124\/jpet.110.170274","volume":"335","author":"Y Hori","year":"2010","unstructured":"Hori Y, Imanishi A, Matsukawa J, Tsukimi Y, Nishida H, Arikawa Y, et al. 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases. 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Before the enactment of the Clinical Trials Act, this study was conducted in accordance with the Ethical Guidelines on Biomedical Research Involving Human Subjects (the Ministry of Education, Culture, Sports, Science and Technology [MEXT] and the Ministry of Health, Labour and Welfare [MHLW], 22 December 2014; this guideline has since been renamed the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects). Owing to the enforcement of the Clinical Trials Act in Japan on 1 April 2018, VISION was classified as a \u2018Specified Clinical Trial\u2019 on 21 November 2018. The transformation review was conducted at \u2018Certified Review Board of National Center for Global Health and Medicine\u2019 (CRB3180021) certified by MHLW, and after that the study was approved and registered under the trial ID jRCTs031180040. Prior to this classification, the study was reviewed by the Ethical Review Boards of each study site (including Ethics Committee: Tohoku University Hospital, reference [ref] no. 2015\u20132-252; Shiga University of Medical Science Research Ethics Committee, ref no. 27\u2013199; Japan Community Health care organization Ethics Review Committee; The Shimane University Institutional Committee on Ethics, ref no. 20160128\u20133; The Ethics Review Board of Hyogo College of Medicine, ref\u00a0no. 318; KKR Takamatsu Hospital Institutional Review Board, ref\u00a0no. E105; Matsuyama Red-cross Hospital Medical Ethics Committee, ref no. 554; Kyushu University Certified Institutional Review Board for Clinical Trials, ref no. 27077; Research Ethics Committee of Kawasaki Medical School and Hospital, ref no. 2383; Institutional Review Board of National Center for Global Health and Medicine, ref no. 2004; Institutional Review Board of National Center for Global Health and Medicine ref no. 2012; Joint Ethical Review Board; Medical Corporation Toukeikai Kitamachi Clinic Ethical Review Board; Maebashi Hirosegawa Clinic Institutional Review Board; Medical Corporation Koyasu Koyasu Neurosurgical Clinic Ethical Review Board; National Hospital Organization Hakodate National Hospital Ethics Review Committee, ref no. H28-0314004; Haradoi Hospital Ethical Review Board; Hospital Ethics Committee Juntendo University Hospital ref no. 16\u2013014; Junpukai Health Maintenance Center Institutional Review Board, ref no. 20160001). Informed written consent was obtained from all study participants before any protocol-specific study procedures.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Yoshikazu Kinoshita received consulting fees for speaking and teaching from AstraZeneca KK, Takeda Pharmaceutical Company Ltd., Daiichi-Sankyo Inc., and Otsuka Pharmaceutical Ltd.Junichi Akiyama received other financial benefits for speaking and teaching, from Takeda Pharmaceutical Company Ltd.Tatsuhiro Kanoo, Kouji Miyata, and Naomi Kusumoto are employees of Takeda Pharmaceutical Company Ltd.Ken Haruma, Naomi Uemura, Takashi Yao, Ryoji Kushima, and Nobuo Aoyama have no conflicts to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"139"}}