J Neurogastroenterol Motil.
2024 Jul;30(3):313-321. 10.5056/jnm23150.
Efficacy of Tegoprazan in Patients With Functional Dyspepsia: A Prospective, Multicenter, Single-arm Study
- Affiliations
-
- 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
- 11Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- KMID: 2557968
- DOI: http://doi.org/10.5056/jnm23150
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.
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Treatment of Helicobacter pylori infection in functional dyspepsia
- Ten-day tegoprazan-based concomitant therapy as a first-line treatment for Helicobacter pylori eradication
- A Randomized Study to Compare Domperidone Maleate with Itopride Hydrochloride in Dysmotility-type Functional Dyspepsia
- Effects of Mosapride on Upper Gastrointestinal Symptoms and Gastric Emptying in Patients with Functional Dyspepsia
- The relationship between functional dyspepsia and family function
