Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi-Center, Randomized, Double-Blind, Active-Comparator Phase 4 Trial.

Su Jin Hong, Ok Jae Lee, Seung Young Kim, Jin Woong Cho, Young Hoon Youn, Cheol Min Shin, Moo In Park, Gwang Ha Kim, Suck Chei Choi, Oh Young Lee, Seong Woo Jeon, Ju Yup Lee, In Kyung Sung, Hye-Kyung Jung, Sang Kil Lee, Yu Kyung Cho, Jeong Eun Shin, Seon-Young Park, Do Hoon Kim, Sang Jin Lee

Journal: Neurogastroenterology and motility 2024;37(1):e14969

PMID: 39587796

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Abstract

BACKGROUND

The aims of this study were to confirm the non-inferiority of tegoprazan to lansoprazole up to week 4 in patients with erosive esophagitis (EE) and to evaluate its effectiveness in rapid mucosal healing and symptom relief at week 2.

METHODS

In this multi-center, randomized, double-blind, active-comparator non-inferiority trial, 218 patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either the tegoprazan (50 mg) or lansoprazole (30 mg) group. The primary endpoint was the cumulative proportion of patients with healed EE up to week 4, as confirmed through endoscopy. The proportion of patients with healed EE at week 2 was also evaluated. Furthermore, CYP2C19 genotypes, symptoms, safety, and tolerability were assessed.

KEY RESULTS

In the full-analysis set, 103 and 109 participants in the tegoprazan and lansoprazole groups, respectively, were analyzed. The cumulative healing rates up to week 4 were 95.2% (98/103) and 86.2% (94/109) (difference [95% confidence interval], 8.91 [1.22-16.59]; p < 0.0001 for non-inferiority and 0.0266 for superiority), while those at week 2 were 88.4% (91/103) and 82.6% (90/109) (5.78 [-3.66-15.22], p = 0.0005 for non-inferiority) for tegoprazan and lansoprazole, respectively. Tegoprazan showed consistent healing rates regardless of CYP2C19 genotypes.

CONCLUSIONS AND INFERENCES

Tegoprazan was superior to lansoprazole in the treatment of EE up to 4 weeks. Further studies are necessary to confirm these findings and clarify the superiority of tegoprazan, especially in the treatment of severe EE.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT05267743.

Address: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.; Department of Gastroenterology, School of Medicine, Wonkwang University, Iksan, Korea.; Department of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea.; Department of Gastroenterology, Korea University Ansan Hospital, Ansan, Korea.; Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Korea.; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Department of Internal Medicine, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea.; Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea.; Department of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.; Department of Gastroenterology, Dankook University Hospital, Cheonan, Korea.; Department of Internal Medicine, Pusan National University College of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.; Department of Gastroenterology, Chonnam National University Hospital, Gwangju, Korea.; Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.; Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Korea.; Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.; Department of Gastroenterology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.; Department of Gastroenterology, Kyungpook National University Chilgok Hospital, Daegu, Korea.; Department of Internal Medicine, Konkuk University Medical Center, Seoul, Korea.; Department of Gastroenterology, Kosin University Gospel Hospital, Busan, Korea.; Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.

DOI: 10.1111/nmo.14969

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MeSH Terms: Humans, Lansoprazole, Male, Female, Double-Blind Method, Middle Aged, Aged, Proton Pump Inhibitors, Treatment Outcome, Adult, Cytochrome P-450 CYP2C19, Esophagitis