Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Summary

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.

Timeline

Start

2019-10-28

Primary completion

2021-07-29

Completion

2021-08-24

Outcome

Met primary endpoint

paper vonoprazan was noninferior to lansoprazole in the primary analysis PMID 36228734 ↗

registry analysis (non-inferiority test); Healing Phase: Vonoprazan 20 mg vs Healing Phase: Lansoprazole 30 mg; p <0.0001; difference in percentage 8.3 (95% CI 4.49 to 12.23) NCT04124926 ↗

registry analysis (non-inferiority test); Maintenance Phase: Vonoprazan 20 mg vs Maintenance Phase: Lansoprazole 15 mg; p <0.0001; difference in percentage 8.7 (95% CI 1.80 to 15.53) NCT04124926 ↗

registry analysis (non-inferiority test); Maintenance Phase: Vonoprazan 10 mg vs Maintenance Phase: Lansoprazole 15 mg; p <0.0001; difference in percentage 7.2 (95% CI 0.21 to 14.09) NCT04124926 ↗

Publications

• 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. Gastroenterology. 2023 Jan;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041. Epub 2022 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lansoprazole	Other / unclassified	15 mg	Oral
Comparator	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	10 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral

Indications