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.

Keywords: Efficacy; Functional dyspepsia; Potassium-competitive acid blocker; Safety.

Figure 1

Flow chart.

Figure 2

Satisfactory symptom relief rate at 8 weeks (A) and 4 weeks (B). EPS, epigastric pain syndrome; PDS, postprandial distress syndrome.

Figure 3

Change from Baseline in Nepean Dyspepsia Index-Korean (NDI-K) score at 4 weeks and 8 weeks (A). Change from Baseline in gastroesophageal reflux disease–health-related quality of life (GERD-HRQL) score at 4 weeks and 8 weeks (B). GERD-Q, gastroesophageal reflux disease questionnaire.