PhD Scientific Days 2022

Pharmaceutical Sciences III. (Poster discussion will take place on the terrace of the room during the Coffee Break)

Comparision of cardiovascular safety of PD-1/PDL-1 inhibitors from the perspective of spontaneous reporting data

Előadó neve

Dr. Mátyás, Pétervári

Előadó munkahelye

Semmelweis University Department of Pharmacology and Pharmacotherapy

Előadó telefonszáma

06306193171

Előadó e-mail címe

petervari.matyas@med.semmelweis-univ.hu

Az előadás címe

Comparision of cardiovascular safety of PD-1/PDL-1 inhibitors from the perspective of spontaneous reporting data

Szerző(k) neve és munkahelye

Pétervári Mátyás1, Eszter Puhl1, Olivér Balogh1, Bettina Benczik1, Ágg Bence1,2 Ferdinandy Péter1,2
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 III. (Poster discussion will take place on the terrace of the room during the Coffee Break)

Language of the presentation

English

Preferred session

Pharmaceutical Sciences

Összefoglaló szövege

Introduction
Cardiovascular related concerns were raised for PD-1/PDL-1 inhibitor drugs in the recent years. Adverse event reports are important sources of safety information in post-marketing phase. Disproportionality analysis in spontaneous reporting datasets to characterize certain risks and this method is applied by the pharmaceutical industry.

Aims
In our study we aimed to compare the cardiovascular risk of PD-1/PDL-1 inhibitor drugs by using reporting odds ratio (ROR) disproportionality analysis within FDA Adverse Event Reporting System (FAERS).

Method
We defined the major adverse cardiovascular event (MACE) list based on literature and translated it to Medical Dictionary for Regulatory Activities, preferred term (PT) codes. World Health Organizations ATC index was reviewed for all PD-1/PDL-1 inhibitor drugs. ROR was calculated for MACE events on selected drugs covering the first quarter (Q1) of 2020 in FAERS by an internally developed program. Drugs below 3 reported events were excluded, and we compared the ROR results to describe the cardiovascular risk of PD-1/PDL-1 inhibitor drugs.

Results
11 PTs were included to the MACE definition and 10 PD-1/PDL-1 inhibitors were selected from the WHO ATC index. 460328 individual case safety reports were collected in FAERS in Q1 2020. 5 drugs were excluded as less than 3 MACE related reports were collected within this period. The highest ROR was found for durvalumab (3.99), while the lowest was for pembrolizumab (1.19).

Conclusion
We developed a software for flexible disproportionality calculation from spontaneous reporting database that allows to describe drug related risk identification in compliance with pharmaceutical industrial standards. MACE related risk of PD-1/PDL-1 inhibitors was compared and durvalumab was found with the highest cardiovascular risk within the group. However, considering the short reporting period and the limitations of disproportionality analysis, further studies are required to fully characterize the performance of the software we developed here.

Funding
PM was supported by EFOP-3.6.3-VEKOP-16-2017-00009 grant and by the Thematic Excellence Programme (2020-4.1.1.-TKP2020) of the Ministry for Innovation and Technology in Hungary, within the framework of the Therapeutic Development and Bioimaging thematic programmes of the Semmelweis University

University and Doctoral School

Semmelweis University, Doctoral School of Pharmaceutical Sciences

Supervisor

Dr. Prof. Ferdinandy Péter

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

6061

Start

13:05

End

13:10

Authors (legacy)

Pétervári Mátyás1, Eszter Puhl1, Olivér Balogh1, Bettina Benczik1, Ágg Bence1,2 Ferdinandy Péter1,2
1Cardiometabolic and MTA-SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary
2Pharmahungary Group, Szeged, Hungary