PhD Scientific Days 2023
Budapest, 22-23 June 2023
Pharmaceutical Sciences - Posters F
Cardiovascular safety of SGLT2i and GLP-1RA combination therapy: disproportionality analysis of the FDA adverse event reporting system
Előadó neve
Dr. Puhl, Eszter
Neptun code
TV52M5
Előadó munkahelye
Semmelweis University Department of Pharmacology and Pharmacotherapy
Előadó telefonszáma
06706016549
Előadó e-mail címe
puhl.eszter@phd.semmelweis.hu
Az előadás címe
Cardiovascular safety of SGLT2i and GLP-1RA combination therapy: disproportionality analysis of the FDA adverse event reporting system
Szerző(k) neve és munkahelye
Eszter Puhl1, Mátyás Pétervári1, Olivér Balogh1, Szandra Marton1, Bence Ágg1,2, Péter Ferdinandy1,2
1Cardiometabolic and MTA-SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary
2Pharmahungary Group, Szeged, Hungary
Bemutatás módja
Poszter
Szekció
Pharmaceutical Sciences - Posters F
Language of the presentation
Hungarian
Preferred session
Pharmaceutical Sciences
Összefoglaló szövege
Introduction
Cardiovascular outcome trials (CVOTs) showed that sodium glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) can reduce major adverse cardiovascular events (MACEs) in people with type 2 diabetes. In recent CVOTs, supporting data emerged for the combined use of these drugs. Disproportionality analysis of spontaneous reporting databases is a widely used tool in the characterization of drug risks.
Aims
We aimed to use reporting odds ratio (ROR) disproportionality analysis within the FDA Adverse Event Reporting System (FAERS) to compare the risks of MACEs for the application of GLP-1RAs, SGLT2 inhibitors and their combined therapy.
Methods
Medical Dictionary for Regulatory Activities Preferred Terms included in MACE definition were selected based on literature. GLP-1RA and SGLT2i drugs were collected with the help of Anatomical Therapeutic Chemical classification system. ROR was calculated by our recently developed R script, which allows us to examine reported drugs in all possible drug roles (suspected, concomitant and interacting) and simultaneous use of different medicine groups. We analyzed spontaneous FAERS reports from the 4th quarter of 2012 to the 1st quarter of 2022.
Results
The ROR for GLP1-RAs and MACEs was higher when we included all drug roles compared to the case of suspected alone (0.38 (95% confidence interval [CI] 0.37 – 0.39) vs. 0.29 (95%CI 0.28-0.30)). For SGLT2i group, this inclusion resulted in a lower ROR (1.41 (95%CI 1.38 – 1.44) vs. 1.49 (95%CI 1.45-1.52)). ROR of the combination (0.60 (95%CI 0.50 – 0.73) vs. 0.53 (95%CI 0.37–0.76)) was higher than for GLP-1RAs alone and lower than for SGLT2 inhibitors alone regardless of the inclusion of the additional drug roles.
Conclusion
We developed a ROR calculation script to analyze all reported drug roles and combination therapies. We found evidence, that the combined use of GLP1-RAs and SGLT2 inhibitors can be beneficial as it reduced the ROR compared to SGLT2i group. However, no substantial change was seen compared to GLP1-RAs. We conclude that more data are needed to clarify the potential cardiovascular safety of GLP-1RA and SGLT2i combination therapy.
Funding
PE was supported by “Semmelweis 250+ Kiválósági PhD Ösztöndíj” grant. Project no. RRF-2.3.1-21-2022-00003 has been implemented with the support provided by the European Union.
University and Doctoral School
Semmelweis University, Doctoral School of Pharmaceutical Sciences
Supervisor
Péter Ferdinandy, MD, PhD, DSc, MBA
Publication of my abstract
I do not give consent to the publication of my abstract on the website of the congress.
Kind
Szabad
Status
elfogadva
Accepted presentation method
poszter
Előadás fájl jóváhagyás
nem rendelkezett róla
Előadó
6032
Start
11:36
End
11:41
Authors (legacy)
Eszter Puhl1, Mátyás Pétervári1, Olivér Balogh1, Szandra Marton1, Bence Ágg1,2, Péter Ferdinandy1,2
1Cardiometabolic and MTA-SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary
2Pharmahungary Group, Szeged, Hungary