Vonoprazan is noninferior and superior to lansoprazole in the treatment and maintenance of erosive esophagitis, according to study findings in Gastroenterology.
The current standard treatment for erosive esophagitis includes proton pump inhibitors (PPI), such as lansoprazole. Potential alternative therapy with potassium-competitive acid blocker vonoprazan has shown more potent gastric acid suppression than PPIs in some studies.
Researchers conducted a randomized, double-blind, parallel-group trial (ClinicalTrials.gov Identifier: NCT04124926) to evaluate the effects of vonoprazan in adults with erosive esophagitis. Study participants were adults with erosive esophagitis confirmed by endoscopy. The trial excluded patients with Helicobacter pylori (H pylori) infection and Barrett esophagus.
Patients were randomly assigned to the healing phase (n=1027) and the maintenance phase (n=893). Participants had a mean age of 51 years, and 61.7% of all participants were from the United States.
This 32-week trial consisted of a study regimen with vonoprazan and an active control with lansoprazole. In the healing phase, patients were randomly assigned to receive once daily vonoprazan 20 mg or lansoprazole 30 mg for up to 8 weeks. During the maintenance phase, patients who displayed endoscopic healing were randomly assigned to receive once daily vonoprazan 10 mg, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks.
The primary endpoint was the percent of healing at week 8 and maintenance of healing at week 24, both confirmed by endoscopy.
The primary efficacy analysis was a noninferiority comparison (noninferiority margins, 10%) using a modified intent-to-treat (mITT) population. This analysis included all randomized patients with erosive esophagitis at baseline in the healing phase or patients with healing who took at least 1 dose of vonoprazan at baseline in the maintenance phase.
The per-protocol analysis included patients assigned the study regimen, those who did not take any additional acid-suppression medications, those who received an endoscopy by week 8 and week 24, and those who were compliant with the treatment without serious protocol deviations.
In the healing phase, the mITT analysis showed that vonoprazan was noninferior to lansoprazole by week 8, with a healing rate of 92.9% vs 84.6%, respectively (95% CI, 4.5-12.2%; P <.0001). The per-protocol analysis revealed that vonoprazan had a healing rate of 94.7% compared with 86.6% for lansoprazole (P <.0001 for noninferiority).
The fixed sequence analyses showed vonoprazan was superior to lansoprazole in healing for LA grade C or D esophagitis during the healing phase (70.2% vs 52.6%; P =.0008). This finding was reflected in the maintenance phase, with both doses of vonoprazan showing superiority in the maintenance of healing in LA grade C or D esophagitis (vonoprazan 20mg [77.2%, P =.020], vonoprazan 10mg [74.7%, P =.049], lansoprazole [61.5%]).
In the maintenance phase, the mITT analysis showed that both doses of vonoprazan (vonoprazan 20mg, 80.7%; vonoprazan 10mg, 79.2%) were noninferior to lansoprazole (72.8%) in the maintenance of healing at week 24 (P <.0001).
The per-protocol analysis also revealed that vonoprazan was noninferior to lansoprazole, with a maintained healing rate of 90.7% for vonoprazan 20mg, 89.2% for vonoprazan 10 mg, and 79.7% for lansoprazole (P <.0001).
Study limitations include the inability to generalize results to patients with H pylori infections, patients with gastroesophageal reflux disease, and patients who are not White European or American.
“The impact of more potent acid inhibition with vonoprazan was seen predominantly in those with more severe esophagitis (LA Grades C or D),” the study authors wrote. “This confirms the importance of maximizing acid inhibition in healing and preventing recurrence of more severe erosive esophagitis.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Laine L, DeVault K, Katz P, et al. Vonoprazan versus lansoprazole for healing anad maintenance of healing of erosive esophagitis: a randomized trial. Gastroenterology. Published online October 10, 2022. doi:10.1053/j.gastro.2022.09.041