J Neurogastroenterol Motil  https://doi.org/10.5056/jnm23150
Efficacy of Tegoprazan in Patients With Functional Dyspepsia: A Prospective, Multicenter, Single-arm Study
Cheal Wung Huh,1 Young Hoon Youn,2* Da Hyun Jung,3 Ra Ri Cha,4 Yeon Ji Kim,1,11 Kyoungwon Jung,5 Kyung Ho Song,6 Ki Bae Bang,7 Chung Hyun Tae,8 Soo In Choi,9 and Cheol Min Shin10; Functional Dyspepsia Research Group Under the Korean Society of Neurogastroenterology and Motility
1Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; 2Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; 3Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; 4Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Jinju, Gyeongsangnam-do, Korea; 5Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea; 6Department of Internal Medicine, CHA Ilsan Medical Center, CHA University, School of Medicine, Goyang, Gyeonggi-do, Korea; 7Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Chungcheongnam-do, Korea; 8Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea; 9Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea; 10Department of Gastroenterology, Seoul National University Bundang Hospital, Bundang, Gyeonggi-do, Korea; and 11Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
Correspondence to: Young Hoon Youn, MD, PhD
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 712 Eonjuro, Gangnam-gu, Seoul 135-720, Korea
Tel: +82-2-2019-3453, E-mail: dryoun@yuhs.ac
Received: September 18, 2023; Revised: November 21, 2023; Accepted: December 17, 2023; Published online: May 4, 2024
© The Korean Society of Neurogastroenterology and Motility. All rights reserved.

Abstract
Background/Aims
Acid-suppressive drugs, such as proton pump inhibitors (PPIs), are treatment options for functional dyspepsia (FD). However, the efficacy of potassium-competitive acid blockers (P-CABs) in treating FD has not yet been established. This prospective multicenter clinical trial-based study aimed to assess the efficacy and safety of tegoprazan as a P-CAB treatment in patients with FD.
Methods
FD was diagnosed using the Rome IV criteria. All patients received tegoprazan 50 mg once daily for 8 weeks. Dyspeptic symptoms were assessed using a dyspepsia symptom questionnaire (5-point Likert scale, Nepean Dyspepsia Index-Korean (NDI-K), and gastroesophageal reflux disease–health-related quality of life (GERD-HRQL). The main outcome was satisfactory symptom relief rates at 8 weeks.
Results
In this study, from the initial screening of 209 patients, 173 were included in the per-protocol set analysis. Satisfactory symptom relief rates at 8 and 4 weeks were 86.7% and 74.6%, respectively. In addition, the NDI-K and GERD-HRQL scores significantly improved at 8 and 4 weeks compared with the baseline scores. The efficacy of tegoprazan was not influenced by the FD subtype or Helicobacter pylori status. In patients with overlapping FD and GERD, there was a greater improvement in the NDI-K and GERD-HRQL scores than in patients with FD symptoms only. No serious drug-related adverse events occurred during this study.
Conclusion
Tegoprazan (50 mg) administered once daily provided satisfactory symptom relief for FD.
Keywords: Efficacy; Functional dyspepsia; Potassium-competitive acid blocker; Safety


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