PMID- 38496864
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240319
IS  - 2405-8440 (Print)
IS  - 2405-8440 (Electronic)
IS  - 2405-8440 (Linking)
VI  - 10
IP  - 6
DP  - 2024 Mar 30
TI  - A real-world disproportionality analysis of FDA adverse event reporting system 
      (FAERS) events for alpelisib.
PG  - e27529
LID - 10.1016/j.heliyon.2024.e27529 [doi]
LID - e27529
AB  - In this study, we delved into the safety profile of alpelisib, an FDA-approved 
      treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced 
      or metastatic breast cancer, and PIK3CA-Related Overgrowth Spectrum (PROS). 
      Despite its approval, real-world, long-term safety data is lacking. Our research 
      scrutinizes the FDA database to assess alpelisib 's safety. We retrospectively 
      analyzed data from April 2019 to June 2023 using four algorithms. Among 7,609,450 
      reports, 6692 implicated alpelisib as the primary suspected drug, uncovering 
      adverse events (AEs) across 26 organ systems. Notably, we identified 21 
      previously unlisted AEs. Furthermore, differences in AEs emerged between patients 
      with PIK3CA-mutated breast cancer and those with PROS. This study provides vital 
      insights for healthcare professionals to navigate AEs in clinical practice and 
      informs future research for enhancing alpelisib 's safety profile.
CI  - (c) 2024 The Authors. Published by Elsevier Ltd.
FAU - Lin, Yu
AU  - Lin Y
AD  - Department of Orthopedics, Pingtan Comprehensive Experimental Area Hospital, 
      Pingtan Comprehensive Experimental Area, 350400, PR China.
AD  - Department of Orthopedics, Fujian Medical University Union Hospital, NO.29 
      Xinquan road, Fuzhou, 350001, PR China.
FAU - Zheng, Xinlei
AU  - Zheng X
AD  - Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan 
      Comprehensive Experimental Area, 350400, PR China.
FAU - Chen, Yan
AU  - Chen Y
AD  - Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan 
      Comprehensive Experimental Area, 350400, PR China.
FAU - Nian, Qichun
AU  - Nian Q
AD  - Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan 
      Comprehensive Experimental Area, 350400, PR China.
FAU - Lin, Li
AU  - Lin L
AD  - Department of Medical Oncology, Shengli Clinical Medical College of Fujian 
      Medical University, Fujian Provincial Hospital, NO.134 Dongjie Street, Fuzhou, 
      350001, Fujian, PR China.
FAU - Chen, Maohua
AU  - Chen M
AD  - Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan 
      Comprehensive Experimental Area, 350400, PR China.
LA  - eng
PT  - Journal Article
DEP - 20240308
PL  - England
TA  - Heliyon
JT  - Heliyon
JID - 101672560
PMC - PMC10944239
OTO - NOTNLM
OT  - Adverse event
OT  - Alpelisib
OT  - Disproportionality analysis
OT  - FAERS database
OT  - Pharmacovigilance
COIS- The authors declare that they have no known competing financial interests or 
      personal relationships that could have appeared to influence the work reported in 
      this paper.
EDAT- 2024/03/18 06:42
MHDA- 2024/03/18 06:43
PMCR- 2024/03/08
CRDT- 2024/03/18 04:44
PHST- 2023/10/09 00:00 [received]
PHST- 2024/02/29 00:00 [revised]
PHST- 2024/03/01 00:00 [accepted]
PHST- 2024/03/18 06:43 [medline]
PHST- 2024/03/18 06:42 [pubmed]
PHST- 2024/03/18 04:44 [entrez]
PHST- 2024/03/08 00:00 [pmc-release]
AID - S2405-8440(24)03560-6 [pii]
AID - e27529 [pii]
AID - 10.1016/j.heliyon.2024.e27529 [doi]
PST - epublish
SO  - Heliyon. 2024 Mar 8;10(6):e27529. doi: 10.1016/j.heliyon.2024.e27529. eCollection 
      2024 Mar 30.