PMID- 34786743
OWN - NLM
STAT- MEDLINE
DCOM- 20220412
LR  - 20220626
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Linking)
VI  - 88
IP  - 5
DP  - 2022 May
TI  - Adverse events of alpelisib: A postmarketing study of the World Health 
      Organization pharmacovigilance database.
PG  - 2180-2189
LID - 10.1111/bcp.15143 [doi]
AB  - AIMS: To explore and describe the adverse reaction signals in the safety 
      reporting for alpelisib. METHODS: We performed a disproportionality analysis of 
      the World Health Organization's VigiBase pharmacovigilance database from 1 
      January 2019 to 30 June 2021. Disproportionality analysis by information 
      components (ICs) were used to evaluate the potential association between adverse 
      events (AEs) and alpelisib. RESULTS: A total of 33 327 reports were extracted, 
      5695 of them were chosen with alpelisib as the suspected drug. After combining 
      the same ID, 687 cases remained. The 45-64-years group had the most cases 
      (n = 203, 29.55%). There were 129 Preferred Terms with significant signals. 
      Hyperglycaemia (IC025 = 6.74), breast cancer metastatic (IC025 = 5.85) and 
      metastases to liver (IC025 = 4.70) were the AEs with the strongest signal. AEs 
      with the most cases were hyperglycaemia (n = 595), rash (n = 535) and diarrhoea 
      (n = 475). CONCLUSION: We established a comprehensive list of AEs potentially 
      associated with alpelisib. AEs with the most significant signals were 
      hyperglycaemia, breast cancer metastatic, metastases to liver. The AEs with the 
      most cases were hyperglycaemia, rash, diarrhoea, blood glucose increase and 
      nausea.
CI  - (c) 2021 British Pharmacological Society.
FAU - Chen, Xiao
AU  - Chen X
FAU - Wei, Lianhui
AU  - Wei L
FAU - Chi, Lijie
AU  - Chi L
FAU - Guo, Xiaojing
AU  - Guo X
FAU - Chen, Chenxin
AU  - Chen C
AD  - Department of Health Statistics, Faculty of Health Service, Naval Medical 
      University, Shanghai, China.
FAU - Guo, Zhijian
AU  - Guo Z
AD  - Department of Health Statistics, Faculty of Health Service, Naval Medical 
      University, Shanghai, China.
FAU - Liang, Jizhou
AU  - Liang J
AD  - Department of Health Statistics, Faculty of Health Service, Naval Medical 
      University, Shanghai, China.
FAU - Zheng, Yi
AU  - Zheng Y
AD  - Department of Health Statistics, Faculty of Health Service, Naval Medical 
      University, Shanghai, China.
FAU - He, Jia
AU  - He J
AD  - Department of Health Statistics, Faculty of Health Service, Naval Medical 
      University, Shanghai, China.
FAU - Ye, Xiaofei
AU  - Ye X
AD  - Department of Health Statistics, Faculty of Health Service, Naval Medical 
      University, Shanghai, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20211206
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
RN  - 0 (Thiazoles)
RN  - 08W5N2C97Q (Alpelisib)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Breast Neoplasms/drug therapy
MH  - Databases, Factual
MH  - Diarrhea
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - *Exanthema
MH  - Female
MH  - Humans
MH  - *Hyperglycemia/chemically induced/epidemiology
MH  - Pharmacovigilance
MH  - Thiazoles
MH  - World Health Organization
OTO - NOTNLM
OT  - VigiBase
OT  - adverse events
OT  - alpelisib
OT  - disproportionality analysis
EDAT- 2021/11/18 06:00
MHDA- 2022/04/13 06:00
CRDT- 2021/11/17 07:07
PHST- 2021/10/13 00:00 [revised]
PHST- 2021/09/03 00:00 [received]
PHST- 2021/11/01 00:00 [accepted]
PHST- 2021/11/18 06:00 [pubmed]
PHST- 2022/04/13 06:00 [medline]
PHST- 2021/11/17 07:07 [entrez]
AID - 10.1111/bcp.15143 [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2022 May;88(5):2180-2189. doi: 10.1111/bcp.15143. Epub 2021 
      Dec 6.