Comparative disproportionality analysis of adverse events associated with combined therapy versus monotherapy of abiraterone and olaparib for prostate cancer: a pharmacovigilance study using the FAERS database.

[OBJECTIVES] This study compares adverse events (AEs) of combined abiraterone acetate and olaparib treatment with their individual treatments for prostate cancer, focusing on safety profile differences and their clinical implications.

[METHODS] Data on AEs for abiraterone acetate and olaparib were extracted from the FDA Adverse Event Reporting System (FAERS) database between April 2011 and April 2024. The reporting odds ratio (ROR) was mainly utilized to analyze AEs and their preferred terms (PTs).

[RESULTS] A total of 32,745 AE reports for abiraterone acetate, 2493 for olaparib and 113 for combination therapy in males were identified. The combination therapy was associated with a higher risk of hematologic and lymphatic disorders and cardiovascular events compared to monotherapy. Notably, venous embolism and acute myocardial infarction showed significant ROR values in the combination therapy group.

[CONCLUSIONS] Combining abiraterone and olaparib increases risks of acute myocardial infarction, embolism, and pneumonitis over monotherapy. Though this combination improves survival, it demands vigilant patient monitoring and risk assessment. We recommend patients undergo serum lipid measurement, electrocardiograms, and cardiac and vascular ultrasounds to facilitate early detection and management of potential adverse effects. Additional research is needed to confirm these results and ensure the safe application of this drug combination.