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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Haruma, Ken Kinoshita, Yoshikazu Yao, Takashi Kushima, Ryoji Akiyama, Junichi Aoyama, Nobuo Kanoo, Tatsuhiro Miyata, Kouji Kusumoto, Naomi Uemura, Naomi |
| Abstract | Background VISION is a randomised, phase 4, open-label, parallel-group, multicentre study conducted in 33 centres in Japan. The aim of this study was to assess the long-term safety of vonoprazan for maintenance treatment of healed erosive oesophagitis versus lansoprazole. Methods Patients with endoscopically diagnosed erosive oesophagitis were randomised 2:1 to once-daily vonoprazan 20 mg or lansoprazole 30 mg, 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 mg or lansoprazole 15 mg. Primary endpoint was change in gastric mucosal histopathology. Results Of 208 patients (vonoprazan, n = 139; lansoprazole, n = 69) entering the healing phase, 202 entered the maintenance phase (vonoprazan, n = 135; lansoprazole, n = 67). At 3 years, 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. Conclusions 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 years. (CT.gov identifier: NCT02679508; JapicCTI-163153; Japan Registry of Clinical Trials: jRCTs031180040). |
| Related Links | https://bmcgastroenterol.biomedcentral.com/counter/pdf/10.1186/s12876-023-02772-w.pdf |
| Ending Page | 17 |
| Page Count | 17 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| DOI | 10.1186/s12876-023-02772-w |
| Journal | BMC Gastroenterology |
| Issue Number | 1 |
| Volume Number | 23 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2023-05-01 |
| Access Restriction | Open |
| Subject Keyword | Gastroenterology Internal Medicine Hepatology GERD or GORD Oesophagus Acidity (oesophageal) Gastric cancer Carcinoid Gastritis Endoscopy |
| Content Type | Text |
| Resource Type | Article |
| Subject | Gastroenterology |
| Journal Impact Factor | 2.5/2023 |
| 5-Year Journal Impact Factor | 2.7/2023 |
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