PMID- 36143391
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220928
IS  - 2075-1729 (Print)
IS  - 2075-1729 (Electronic)
IS  - 2075-1729 (Linking)
VI  - 12
IP  - 9
DP  - 2022 Aug 31
TI  - Comprehensive Analysis of Adverse Events Induced by PARP Inhibitors Using JADER 
      and Time to Onset.
LID - 10.3390/life12091355 [doi]
LID - 1355
AB  - 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.
FAU - Yamaoka, Kenta
AU  - Yamaoka K
AD  - Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe 650-0047, 
      Japan.
AD  - School of Pharmacy, Hyogo Medical University, Kobe 650-8530, Japan.
FAU - Fujiwara, Masaki
AU  - Fujiwara M
AD  - Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe 650-0047, 
      Japan.
AD  - School of Pharmacy, Hyogo Medical University, Kobe 650-8530, Japan.
FAU - Uchida, Mayako
AU  - Uchida M
AUID- ORCID: 0000-0003-0507-7309
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe 
      610-0395, Japan.
FAU - Uesawa, Yoshihiro
AU  - Uesawa Y
AUID- ORCID: 0000-0002-5773-991X
AD  - Department of Medical Molecular Informatics, Meiji Pharmaceutical University, 
      Tokyo 204-8588, Japan.
FAU - Muroi, Nobuyuki
AU  - Muroi N
AD  - Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe 650-0047, 
      Japan.
FAU - Shimizu, Tadashi
AU  - Shimizu T
AUID- ORCID: 0000-0002-5563-6730
AD  - School of Pharmacy, Hyogo Medical University, Kobe 650-8530, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220831
PL  - Switzerland
TA  - Life (Basel)
JT  - Life (Basel, Switzerland)
JID - 101580444
PMC - PMC9504973
OTO - NOTNLM
OT  - Japanese Adverse Drug Event Reporting (JADER)
OT  - Poly (ADP-ribose) polymerase (PARP) inhibitor
OT  - niraparib
OT  - olaparib
OT  - pharmacovigilance
OT  - spontaneous reporting system
COIS- The authors declare no conflict of interest.
EDAT- 2022/09/24 06:00
MHDA- 2022/09/24 06:01
PMCR- 2022/08/31
CRDT- 2022/09/23 01:30
PHST- 2022/08/10 00:00 [received]
PHST- 2022/08/28 00:00 [revised]
PHST- 2022/08/29 00:00 [accepted]
PHST- 2022/09/23 01:30 [entrez]
PHST- 2022/09/24 06:00 [pubmed]
PHST- 2022/09/24 06:01 [medline]
PHST- 2022/08/31 00:00 [pmc-release]
AID - life12091355 [pii]
AID - life-12-01355 [pii]
AID - 10.3390/life12091355 [doi]
PST - epublish
SO  - Life (Basel). 2022 Aug 31;12(9):1355. doi: 10.3390/life12091355.