Cardiac safety signals associated with PARP inhibitors: a disproportionality analysis of eudravigilance data
Clicks: 2
ID: 323499
2026
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This
article has not been analysed, so there is no overall score —
reader engagement is measured and shown alongside.
Reader Engagement
Emerging Content
0.3
/100
2 views
1 readers
AI Quality Assessment
Not analyzed
Readership in this journal
EmergingRanked #262 of 282 articles by views in European heart journal supplements : journal of the European Society of Cardiology
Most read
Least read
Bar heights use a square-root scale. Only the 120 most-read articles are drawn; the journal has 282 in total.
Mint this article as an NFT
Not yet mintedCreate a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.
5
SUSD
one-off · no wallet required
Abstract
Abstract Background PARP inhibitors (PARPi) have transformed treatment of BRCA-mutant and homologous recombination-deficient cancers, but cardiovascular adverse events were not a primary focus of pivotal trials. Clinical evidence and meta-analyses suggest PARPi therapy may increase the risk of major adverse cardiovascular events, hypertension, and thromboembolic events compared with controls, although severe events remain rare. Real-world disproportionality analyses from FAERS have identified cardiovascular safety signals, particularly with niraparib, underscoring the value of post-marketing surveillance. However, a comprehensive EudraVigilance (EV) analysis comparing cardiac safety across olaparib, niraparib, rucaparib, and talazoparib has not been reported, highlighting an unmet need for class-wide pharmacovigilance. Purpose We sought to explore signals of disproportionate reporting (SDR) of drug–event pairs (DEP) involving PARPi and cardiac adverse events. Methods We screened for SDRs within the MedDRA-defined cardiac disorders system-organ class (SOC), by using cumulative reports from the EV database. Reporting odds ratios (RORs) with no Bayesian shrinkage and corresponding 95% confidence intervals were calculated to enable comparison of reporting frequencies against all other drugs in the database. SDRs were defined as drug–event pairs with a lower bound of the 95% confidence interval of the ROR greater than 1 and a minimum of 5 reports. Inclusion of events in the Important Medical Event (IME) list was pre-specified. Results Our analysis revealed a heterogeneous pattern of reporting frequencies across cardiac disorder PTs for the four drugs taken under study. SDRs were found across the "cardiac arrhythmias", "cardiac valve disorders" and "cardiac disorders, signs and symptoms nec" high level terms (HLT) for niraparib, whereas talazoparib displayed disproportionate reporting within the "pericardial disorders" HLT. The most distinctive SDRs of niraparib were associated with the cardiac flutter PT(ROR 4.78, 2.81-7.12), followed by palpitations (ROR 2.61, 2.30-2.96) and cardiac valve disease (ROR 2.96, 1.41-6.23). Talazoparib was disproportionately reported together with pericardial effusion events (ROR 3.67, 1.52-8.86). No SDRs were identified for cardiac disorder PTs with olaparib or rucaparib. Conclusion Analysis of EV data revealed heterogeneous cardiac safety reporting among PARPi, supporting the presence of distinct drug-specific signals rather than a uniform class effect. Niraparib was associated with disproportionate reporting of arrhythmias and cardiac valve disorders, whereas talazoparib showed signals related to pericardial events; no cardiac signals were detected for olaparib or rucaparib. These findings emphasize the importance of agent-specific cardiovascular surveillance and underscore the value of post-marketing safety monitoring in characterizing differential cardiac risk within this therapeutic class.
| Reference Key |
openalex_W7172296278
Use this key to autocite in the manuscript while using
SciMatic Manuscript Manager or Thesis Manager
|
|---|---|
| Authors | D Urdea, A Draghici, S Elrashidy, Y Shhab, I Tarabasanu-Mihaila, A Tariq |
| Journal | European heart journal supplements : journal of the European Society of Cardiology |
| Year | 2026 |
| DOI |
10.1093/eurheartjsupp/suag097.093
|
| URL | |
| Keywords | Keywords not found |
Citations
No citations found. To add a citation, contact the admin at info@scimatic.org
Comments
No comments yet. Be the first to comment on this article.