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Vonoprazan as a Long-term Maintenance Treatment for Erosive Esophagitis: VISION, a 5-Year, Randomized, Open-label
Naomi Uemura1, Yoshikazu Kinoshita2, Ken Haruma3
1Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Ichikawa, Chiba, Japan.
Summary
Long-term use of vonoprazan for erosive esophagitis showed increased gastrin levels and gastric mucosal changes, but no higher risk of malignancy compared to lansoprazole.
Area of Science:
- Gastroenterology
- Pharmacology
- Oncology
Background:
- Acid secretion inhibitors can cause hypergastrinemia and gastric mucosal changes.
- Potassium-competitive acid blockers (vonoprazan) are potent but lack long-term safety data.
- Erosive esophagitis (EE) requires effective and safe long-term management.
Purpose of the Study:
- To assess the long-term safety of vonoprazan versus lansoprazole in patients with healed EE.
- To evaluate the incidence of gastric mucosal alterations and neoplastic changes.
Main Methods:
- Phase IV randomized trial with 202 patients receiving maintenance therapy for 260 weeks.
- Vonoprazan (10 mg) vs. lansoprazole (15 mg) daily.
- Primary endpoint: proportion of patients with specific gastric epithelial cell alterations.
Main Results:
- No malignant alterations or gastric neuroendocrine tumors (NETs) observed in either group.
- Higher incidences of parietal cell and foveolar hyperplasia with vonoprazan.
- Similar rates of ECL cell and G-cell hyperplasia; higher median serum gastrin with vonoprazan.
- Comparable adverse event profiles between vonoprazan and lansoprazole.
Conclusions:
- Five-year safety profile of vonoprazan in Japanese patients with healed EE was assessed.
- Vonoprazan led to higher gastrin levels and specific hyperplasias but no increased risk of malignancy.
- Results suggest vonoprazan is a safe alternative for long-term EE management.
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