Vonoprazan Shows Efficacy in Healing of Erosive Esophagitis

Vonoprazan not only demonstrated noninferiority to lansoprazole for both healing and maintenance of healing in patients with erosive esophagitis, but also showed higher rates of patients achieving each end point — mostly among those with more severe esophagitis. Researchers published their findings in Gastroenterology.

“Our prespecified analyses indicated superiority for vonoprazan in patients with Los Angeles Grade C/D esophagitis, while post hoc analyses did not establish superiority in those with Los Angeles Grade A/B esophagitis,” wrote corresponding author Loren Laine, MD, of Yale School of Medicine, New Haven, Connecticut, and study coauthors.

The randomized trial compared the proton pump inhibitor lansoprazole with vonoprazan, a potassium-competitive acid blocker known to provide potent acid inhibition but which lacked data in erosive esophagitis. In the initial 8-week (healing) phase of the study, 1024 adults with erosive esophagitis were randomized either to once-daily vonoprazan 20 mg, or lansoprazole 30 mg. In a subsequent 24-week (maintenance of healing) phase, 878 participants with healing were rerandomized to once-daily vonoprazan 10 mg or 20 mg, or lansoprazole 15 mg.

To meet the standard of noninferiority, the study required a 10% noninferiority margin. When noninferiority was met, a superiority analysis was performed.

In the initial phase of the trial, vonoprazan was noninferior to lansoprazole in the primary analysis of healing and superior in the predefined exploratory analysis of healing (92.9% vs 84.6%), according to the study. Vonoprazan demonstrated noninferiority in heartburn-free days (2.7% difference) and superiority in healing Los Angeles Classification Grade C/D esophagitis at week 2 (17.6% difference).

In the maintenance phase of the trial, vonoprazan was noninferior to lansoprazole in the primary analysis and superior in the secondary analysis of maintenance of healing (vonoprazan 2- mg, 80.7%; vonoprazan 10 mg, 79.2%; lansoprazole 15 mg, 72%). Vonoprazan also demonstrated superiority in the secondary analysis of maintenance of healing Grade C/D esophagitis (15.7% difference between 20-mg vonoprazan and 15-mg lansoprazole; 13.3% difference between 10-mg vonoprazan and 15-mg lansoprazole).

“Vonoprazan is an effective alternative to lansoprazole for treatment of patients with erosive esophagitis, especially for those with more severe disease,” researchers advised.

Reference:
Laine L, DeVault K, Katz P, et al. Vonoprazan versus lansoprazole for healing and maintenance of healing of erosive esophagitis: a randomized trial. Gastroenterology. 2023;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041