麻豆传媒

Background & 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 re-randomized to once-daily vonoprazan 10 mg, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks. Primary endpoints, percentage with healing by week-8 endoscopy and maintenance of healing at week-24 endoscopy, were assessed in noninferiority comparisons (noninferiority margins = 10%), with superiority analyses prespecified if noninferiority was demonstrated. Analyses of primary and secondary endpoints were performed using fixed-sequence testing procedures.

Results

Among 1,024 patients in the healing phase, vonoprazan was noninferior to lansoprazole in primary analysis and superior on exploratory analysis of healing (92.9% vs 84.6%; difference 8.3%, 95% CI 4.5-12.2). Secondary analyses showed vonoprazan noninferior in heartburn-free days (difference 2.7%, 95% CI -1.6 to 7.0), and superior in healing Grade C/D esophagitis at week 2 (difference 17.6%, 95% CI 7.4-27.4). Among 878 patients in maintenance phase, vonoprazan was noninferior to lansoprazole in primary analysis and superior on 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 noninferior and superior to the PPI lansoprazole in healing and maintenance of healing of erosive esophagitis. This benefit was seen predominantly in more severe erosive esophagitis.

You can read an interview with the lead study author here, and about the clinical implications of the study here.