Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset
Poly (ADP-ribose) polymerase (PARP) inhibitors are effective against breast cancer susceptibility gene (<i>BRCA</i>) mutations. Clinical trials have reported hematologic toxicity and gastrointestinal symptoms as class effects of PARP inhibitors. However, information on adverse events (AE...
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MDPI AG
2022-08-01
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| Series: | Life |
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| Online Access: | https://www.mdpi.com/2075-1729/12/9/1355 |
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| author | Kenta Yamaoka Masaki Fujiwara Mayako Uchida Yoshihiro Uesawa Nobuyuki Muroi Tadashi Shimizu |
| author_facet | Kenta Yamaoka Masaki Fujiwara Mayako Uchida Yoshihiro Uesawa Nobuyuki Muroi Tadashi Shimizu |
| author_sort | Kenta Yamaoka |
| collection | DOAJ |
| description | Poly (ADP-ribose) polymerase (PARP) inhibitors are effective against breast cancer susceptibility gene (<i>BRCA</i>) 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. |
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| format | Article |
| id | doaj.art-e4e19e853cd34a2185afb6534ab12f6e |
| institution | Directory Open Access Journal |
| issn | 2075-1729 |
| language | English |
| last_indexed | 2024-03-09T23:23:54Z |
| publishDate | 2022-08-01 |
| publisher | MDPI AG |
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| series | Life |
| spelling | doaj.art-e4e19e853cd34a2185afb6534ab12f6e2023-11-23T17:22:42ZengMDPI AGLife2075-17292022-08-01129135510.3390/life12091355Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to OnsetKenta Yamaoka0Masaki Fujiwara1Mayako Uchida2Yoshihiro Uesawa3Nobuyuki Muroi4Tadashi Shimizu5Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe 650-0047, JapanDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe 650-0047, JapanDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women’s College of Liberal Arts, Kyotanabe 610-0395, JapanDepartment of Medical Molecular Informatics, Meiji Pharmaceutical University, Tokyo 204-8588, JapanDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe 650-0047, JapanSchool of Pharmacy, Hyogo Medical University, Kobe 650-8530, JapanPoly (ADP-ribose) polymerase (PARP) inhibitors are effective against breast cancer susceptibility gene (<i>BRCA</i>) 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.https://www.mdpi.com/2075-1729/12/9/1355Poly (ADP-ribose) polymerase (PARP) inhibitorolaparibniraparibspontaneous reporting systemJapanese Adverse Drug Event Reporting (JADER)pharmacovigilance |
| spellingShingle | Kenta Yamaoka Masaki Fujiwara Mayako Uchida Yoshihiro Uesawa Nobuyuki Muroi Tadashi Shimizu Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset Life Poly (ADP-ribose) polymerase (PARP) inhibitor olaparib niraparib spontaneous reporting system Japanese Adverse Drug Event Reporting (JADER) pharmacovigilance |
| title | Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset |
| title_full | Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset |
| title_fullStr | Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset |
| title_full_unstemmed | Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset |
| title_short | Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER and Time to Onset |
| title_sort | comprehensive analysis of adverse events induced by parp inhibitors using jader and time to onset |
| topic | Poly (ADP-ribose) polymerase (PARP) inhibitor olaparib niraparib spontaneous reporting system Japanese Adverse Drug Event Reporting (JADER) pharmacovigilance |
| url | https://www.mdpi.com/2075-1729/12/9/1355 |
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