PhD Scientific Days 2026

Budapest, 16-18 June 2026

Poster Session 1.F - Pharmaceutical Sciences and Health Technologies

Enteropathy in Patients Receiving Alpha-2 or Imidazoline-1 Receptor Agonists and the Role of Concomitant NSAID Therapy: A Disproportionality Analysis of Spontaneous Reports

Előadó neve

Dr. Puhl, Eszter

Neptune code

TV52M5

Előadó munkahelye

Department of Pharmacology and Pharmacotherapy, Semmelweis University, H-1085 Budapest, Hungary

Előadó telefonszáma

06706016549

Előadó e-mail címe

puhl.esz@gmail.com

Az előadás címe

Enteropathy in Patients Receiving Alpha-2 or Imidazoline-1 Receptor Agonists and the Role of Concomitant NSAID Therapy: A Disproportionality Analysis of Spontaneous Reports

Szerző(k) neve és munkahelye

Eszter Puhl1,2, Mátyás Pétervári1,2,3, Olivér M. Balogh1,2, Barnabás Váradi1,2, András S. Tóth1,2, Zoltán S. Zádori1,2, Péter Ferdinandy1,2,4, Bence Ágg1,2,4

1: Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest
2: Center for Pharmacology and Drug Research & Development, Semmelweis University, Budapest
3: Sanovigado Kft., Budapest, Hungary
4: Pharmahungary Group, Szeged, Hungary

Bemutatás módja

Poszter

Szekció

Poster Session 1.F - Pharmaceutical Sciences and Health Technologies

Language of the presentation

Hungarian

Preferred session

Pharmaceutical Sciences and Health Technologies

Összefoglaló szövege

Introduction We evaluated adverse event reports of enteropathy in patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs), alpha-2 or imidazoline-1 receptor agonists, and their concomitant use.
Aims To compare reporting of enteropathy associated with these therapies using reporting odds ratio (ROR)-based disproportionality analysis of the FDA Adverse Event Reporting System (FAERS).
Methods A total of 49 Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA® PTs) were selected to define enteropathy. Drugs were identified using the Anatomical Therapeutic Chemical classification system. RORs were calculated with a custom R script. FAERS reports from Q4 2012 to Q3 2025 were analyzed.
Results Reporting of enteropathy PT group was assessed in patients receiving NSAIDs, alpha-2 or imidazoline-1 receptor agonists, and their combination. ROR for combination therapy was 1.33 (95% CI 1.19–1.49), compared with 1.72 (95% CI 1.69–1.75) for NSAIDs alone and 1.16 (95% CI 1.08–1.23) for alpha-2 or imidazoline-1 receptor agonists alone. For NSAIDs, signals were detected across all classes except Butylpyrazolidines, and acetylsalicylic acid (ASA) was the most frequently reported individual drug in association with enteropathy PTs. Multiple signals were identified at the level of individual NSAIDs and PTs. For alpha-2 or imidazoline-1 receptor agonists, two signals were identified for enteropathy PT group (tizanidine: ROR 1.28, 95% CI 1.15–1.41; clonidine: ROR 1.21, 95% CI 1.11–1.33), along with 19 signals at the level of individual drugs and PTs.
Conclusion Most NSAID classes and ASA were associated with enteropathy PTs, consistent with known safety profiles, which served as a validation of our analytical approach. Signals were also identified for alpha-2 or imidazoline-1 receptor agonists: only one of the 19 signals is currently included in the Summary of Product Characteristics. This highlights the need for further evaluation, where both methodological and clinical validation are required to confirm our approach and assess potential causal relationships. The combination therapy showed an intermediate ROR compared with the individual drug groups, warranting further investigation.
Funding E.P. was supported by Semmelweis 250+ Excellence Fellowship. Project no. RRF-2.3.1-21-2022-00003 has been implemented with the support provided by the European Union.

University

Semmelweis University

Supervisor

Péter Ferdinandy, MD, PhD, DSc, MBA; Bence Ágg, MD, PhD

Publication of my abstract

I do not give consent to the publication of my abstract on the website of the congress.

phd.section.field

after finishing doctoral studies with absolutorium (PhD)

Kind

Szabad

Status

elfogadva

Accepted presentation method

poszter

Előadás fájl jóváhagyás

nem rendelkezett róla

Előadó

6032

Start

17:18

End

17:21