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
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 w...
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BMC
2023-05-01
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| Series: | BMC Gastroenterology |
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| Online Access: | https://doi.org/10.1186/s12876-023-02772-w |
| _version_ | 1797832008913649664 |
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| author | Ken Haruma Yoshikazu Kinoshita Takashi Yao Ryoji Kushima Junichi Akiyama Nobuo Aoyama Tatsuhiro Kanoo Kouji Miyata Naomi Kusumoto Naomi Uemura |
| author_facet | Ken Haruma Yoshikazu Kinoshita Takashi Yao Ryoji Kushima Junichi Akiyama Nobuo Aoyama Tatsuhiro Kanoo Kouji Miyata Naomi Kusumoto Naomi Uemura |
| author_sort | Ken Haruma |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-04-09T14:01:56Z |
| format | Article |
| id | doaj.art-2f02b000109344979a706742cda72ca1 |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-04-09T14:01:56Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| spelling | doaj.art-2f02b000109344979a706742cda72ca12023-05-07T11:14:53ZengBMCBMC Gastroenterology1471-230X2023-05-0123111710.1186/s12876-023-02772-wRandomised 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 oesophagitisKen Haruma0Yoshikazu Kinoshita1Takashi Yao2Ryoji Kushima3Junichi Akiyama4Nobuo Aoyama5Tatsuhiro Kanoo6Kouji Miyata7Naomi Kusumoto8Naomi Uemura9Department of General Internal Medicine 2, Kawasaki Medical School, General Medical CenterGeneral Internal Medicine, Hyogo Prefectural Harima-Himeji General Medical CenterDepartment of Human Pathology, Juntendo University Graduate School of MedicineDepartment of Clinical Laboratory Medicine, Shiga University of Medical Science HospitalDepartment of Gastroenterology and Hepatology, National Center for Global Health and MedicineGI Endoscopy and IBD Center, Aoyama Medical ClinicTakeda Pharmaceutical Company LtdTakeda Pharmaceutical Company LtdTakeda Pharmaceutical Company LtdDepartment of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai HospitalAbstract 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).https://doi.org/10.1186/s12876-023-02772-wGERD or GORDOesophagusAcidity (oesophageal)Gastric cancerCarcinoidGastritis |
| spellingShingle | Ken Haruma Yoshikazu Kinoshita Takashi Yao Ryoji Kushima Junichi Akiyama Nobuo Aoyama Tatsuhiro Kanoo Kouji Miyata Naomi Kusumoto Naomi Uemura 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 BMC Gastroenterology GERD or GORD Oesophagus Acidity (oesophageal) Gastric cancer Carcinoid Gastritis |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | GERD or GORD Oesophagus Acidity (oesophageal) Gastric cancer Carcinoid Gastritis |
| url | https://doi.org/10.1186/s12876-023-02772-w |
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