Esophagus to Small Intestine
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.