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 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).

Iron deposition in gastric black spots: Clinicopathological insights and NanoSuit‐correlative light and electron microscopy analysis

“…These findings align with those from the VISION trial and suggest that the differing likelihood of BS occurrence between PPIs and vonoprazan could stem from variations in their mechanisms of acid suppression. 17 …”

Acid‐suppressive drugs: A systematic review and network meta‐analysis of their nocturnal acid‐inhibitory effect

“…43 A clinical study evaluating the long-term safety of vonoprazan in the treatment of reflux esophagitis reported no serious adverse events such as gastric mucosal neoplasia after 3 years of vonoprazan maintenance. 44 Carcinoid tumors have been reported after long-term use of PPIs. 45 In addition, night-time acid suppression by tegoprazan and vonoprazan was not dependent on CYP2C19 phenotypes, whereas esomeprazole tended to be influenced by CYP2C19 phenotypes.…”

Potassium-competitive acid blocker-associated gastric mucosal lesions

“…Results from the VISION trial 17 highlighted a notable increase in the prevalence rate of HPs from 3.7% to 14.7% over a threeyear period in patients initiating P-CAB treatment. Additionally, Shinozaki et al 18 reported a notably higher prevalence of HP among patients receiving P-CAB for more than one year compared to that of non-P-CAB users.…”

“…The other case report by Nishimura et al 16 discussed the notable decrease and regression of FGPs subsequent to P-CAB discontinuation in a patient with anemia, with a concomitant reduction in serum gastrin levels compared to that before drug discontinuation. Moreover, Haruma et al 17 conducted a multicenter prospective study (VISION trial) and reported a noteworthy increase in the prevalence of FGPs from 43.7% to 66.1% over a three-year period following the initiation of P-CAB therapy. Additionally, Shinozaki et al 18 found a notably higher prevalence of FGPs among patients receiving P-CAB for more than one year compared to that in non-P-CAB users.…”