Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

Summary

This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

Timeline

Start

2015-04-01

Primary completion

2018-12-24

Completion

2018-12-31

Outcome

Met primary endpoint

paper meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 weeks. PMID 38654422 ↗

paper differences: -12.3% [95% CI, -20.3% to -4.3%] and -13.3% [95% CI, -21.3% to -5.3%], respectively PMID 38654422 ↗

Publications

• Xiao Y, Qian J, Zhang S, Dai N, Chun HJ, Chiu C, Chong CF, Funao N, Sakurai Y, Eisner JD, Xie L, Chen M. Vonoprazan 10 mg or 20 mg vs. lansoprazole 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis: A randomized controlled trial. Chin Med J (Engl). 2024 Apr 20;137(8):962-971. doi: 10.1097/CM9.0000000000003068. Epub 2024 Mar 29.

Drugs

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

Indications