Esophagus to Small Intestine

Gastroenterology. 2023;164(1):61–71

Laine L, DeVault K, Katz P, Mitev S, Lowe J, Hunt B, Spechler S

Vonoprazan versus lansoprazole for healing and maintenance of healing of erosive esophagitis: A randomized trial

Background and aims: For decades, proton-pump inhibitors (PPIs) have been the mainstay of treatment for erosive esophagitis. The potassium-competitive acid blocker vonoprazan provides more potent acid inhibition than PPIs, but data on its efficacy for erosive esophagitis are limited.
Methods: Adults with erosive esophagitis were randomized to once-daily vonoprazan 20 mg or lansoprazole 30 mg for up to 8 weeks. Patients with healing were rerandomized to once-daily vonoprazan 10 mg, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks. Primary end points, percentage with healing by week 8 endoscopy, and maintenance of healing at week 24 endoscopy, were assessed in non-inferiority comparisons (non-inferiority margins, 10%), with superiority analyses prespecified if non-inferiority was demonstrated. Analyses of primary and secondary end points were performed using fixed-sequence testing procedures.
Results: Among 1024 patients in the healing phase, vonoprazan was non-inferior to lansoprazole in the primary analysis and superior on the exploratory analysis of healing (92.9% vs. 84.6%; difference, 8.3%; 95% confidence interval [CI]: 4.5–12.2%). Secondary analyses showed vonoprazan was non-inferior in heartburn-free days (difference, 2.7%; 95% CI: -1.6–7.0%), and superior in healing Los Angeles Classification Grade C/D esophagitis at week 2 (difference, 17.6%; 95% CI: 7.4–27.4%). Among 878 patients in the maintenance phase, vonoprazan was non-inferior to lansoprazole in the primary analysis and superior on the secondary analysis of maintenance of healing (20 mg vs. lansoprazole: difference, 8.7%; 95% CI: 1.8–15.5%; 10 mg vs. lansoprazole: difference, 7.2%; 95% CI: 0.2–14.1%) and secondary analysis of maintenance of healing Grade C/D esophagitis (20 mg vs. lansoprazole: difference, 15.7%; 95% CI: 2.5–28.4%; 10 mg vs. lansoprazole: difference, 13.3%; 95% CI: 0.02–26.1%).

Conclusions: Vonoprazan was non-inferior and superior to the proton-pump inhibitor lansoprazole in healing and maintenance of healing of erosive esophagitis. This benefit was seen predominantly in more severe erosive esophagitis.

L. Laine, M.D., Professor of Medicine, Section of Digestive Diseases, Yale School of Medicine, New Haven, CT, USA,

DOI: DOI: 10.1053/j.gastro.2022.09.041

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