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Efficacy of Tegoprazan in Patients With Functional Dyspepsia: A Prospective, Multicenter, Single-arm Study.


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.

SUBMITTER: Huh CW 

PROVIDER: S-EPMC11238105 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Publications

Efficacy of Tegoprazan in Patients With Functional Dyspepsia: A Prospective, Multicenter, Single-arm Study.

Huh Cheal Wung CW   Youn Young Hoon YH   Jung Da Hyun DH   Cha Ra Ri RR   Kim Yeon Ji YJ   Jung Kyoungwon K   Song Kyung Ho KH   Bang Ki Bae KB   Tae Chung Hyun CH   Choi Soo In SI   Shin Cheol Min CM  

Journal of neurogastroenterology and motility 20240504 3


<h4>Background/aims</h4>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.<h4>Methods</h4>FD was diagnosed using the Rome IV criteria. All patients received tegoprazan  ...[more]

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