Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset

Abstract

Poly (ADP-ribose) polymerase (PARP) inhibitors are effective against breast cancer susceptibility gene (BRCA) mutations. Clinical trials have reported hematologic toxicity and gastrointestinal symptoms as class effects of PARP inhibitors. However, information on adverse events (AEs) in a Japanese clinical cohort is currently lacking. In this study, we conducted a comprehensive survey of the AEs of two PARP inhibitors, olaparib and niraparib, using the Japanese Adverse Reaction Reporting (JADER) database provided by the Pharmaceuticals and Medical Devices Agency (PMDA). Moreover, we also analyzed the course and time to the onset of AEs. Signals were detected for 15 and 11 AEs for olaparib and niraparib, respectively. Most occurred within the first month of treatment with either agent. These results may indicate the importance of early response and monitoring after beginning PARP inhibitor therapy. The results of this study may be useful for managing side effects and suggesting supportive care for patients using PARP inhibitors in the future.

Keywords

• Poly (ADP-ribose) polymerase (PARP) inhibitor
• olaparib
• niraparib
• spontaneous reporting system
• Japanese Adverse Drug Event Reporting (JADER)
• pharmacovigilance