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Patient-Reported Epigastric Symptom Dynamics During Trimebutine Maleate Treatment: A Post-Marketing Study
Svetoslav Stoev1, Vesselina Yanachkova2,3, Elina Petkova-Gueorguieva4
1Department of Pharmaceutical Sciences and Social Pharmacy, Faculty of Pharmacy, Medical University-Pleven, 5800 Pleven, Bulgaria.
Medicina (Kaunas, Lithuania)
|March 28, 2026
Summary
Trimebutine maleate effectively reduced symptoms in patients with functional gastrointestinal disorders (FGIDs), including irritable bowel syndrome (IBS). This real-world study supports its use in clinical practice.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Medicine
Background:
- Functional gastrointestinal disorders (FGIDs) represent a significant clinical challenge.
- Trimebutine maleate is a potential therapeutic agent for FGIDs.
Purpose of the Study:
- To evaluate the real-world effectiveness of trimebutine maleate in FGID patients.
- To assess patient-reported outcomes for trimebutine maleate therapy.
Main Methods:
- Prospective, non-interventional, multicenter study.
- 2501 patients with FGIDs (IBS, functional dyspepsia) across 50 clinical sites.
- Validated questionnaire (adapted Izumo scale) for symptom and quality of life assessment.
Main Results:
- Significant reduction in symptom severity, including epigastric pain and defecation difficulties.
- Mean pain scores decreased from 2.65 to 0.46 (p < 0.001).
- Early symptom improvement observed by the second visit.
Conclusions:
- Trimebutine maleate demonstrated well-tolerated and effective therapy in real-world Bulgarian clinical practice for IBS.
- Supports the inclusion of trimebutine maleate in future clinical guidelines for FGIDs.
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