PMID- 35316861
OWN - NLM
STAT- MEDLINE
DCOM- 20220824
LR  - 20220824
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 47
IP  - 8
DP  - 2022 Aug
TI  - Comprehensive analysis of everolimus-induced adverse events using the Japanese 
      real-world database.
PG  - 1173-1180
LID - 10.1111/jcpt.13648 [doi]
AB  - WHAT IS KNOWN AND OBJECTIVES: As for adverse events (AEs) caused by everolimus, 
      findings from clinical trials and post-marketing surveillance have reported 
      interstitial lung disease, hyperglycaemia, cardiovascular disease, etc. However, 
      these reports are limited to incidence, and detailed studies on the risk of 
      occurrence, time to onset and post-event clinical outcomes are only related to 
      hyperglycaemia. The purpose of this study was to perform a comprehensive analysis 
      of adverse events during everolimus therapy in patients with renal cell carcinoma 
      (RCC) using the Japanese Adverse Event Report database. METHODS: Data reported 
      between April 2004 and June 2021 in the Japanese Adverse Drug Event Report 
      database were extracted for use. The reported odds ratio, time to onset and 
      post-event course were analysed for the top 30 adverse events reported. RESULTS 
      AND DISCUSSION: Among the top 30 adverse events, 23 adverse event signals were 
      detected and classified into seven categories: lung-related AEs, 
      haematological-related AEs, cancer progression, blood glucose-related AEs, 
      hepatic-related AEs, renal-related AEs and others. The lung-related adverse 
      events category was the most common, and the proportion of fatal outcomes after 
      the occurrence of two adverse events related to infectious pneumonia was more 
      than 10%. WHAT IS NEW AND CONCLUSION: A comprehensive survey of adverse events 
      associated with everolimus administration using the pharmacovigilance database 
      revealed that pulmonary and haematological AEs are frequently reported. The 
      results suggest that attention should be paid to the occurrence of lung disorders 
      because they may lead to fatal outcomes.
CI  - (c) 2022 John Wiley & Sons Ltd.
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, 
      Kyoto, Japan.
FAU - Nakano, Kana
AU  - Nakano K
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 
      Kyoto, Japan.
FAU - Fujiwara, Masaki
AU  - Fujiwara M
AD  - School of Pharmacy, Hyogo University of Health Sciences, Kobe, Hyogo, Japan.
FAU - Uesawa, Yoshihiro
AU  - Uesawa Y
AD  - Department of Medical Molecular Informatics, Meiji Pharmaceutical University, 
      Tokyo, Japan.
FAU - Shimizu, Tadashi
AU  - Shimizu T
AUID- ORCID: 0000-0002-5563-6730
AD  - School of Pharmacy, Hyogo University of Health Sciences, Kobe, Hyogo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220322
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 9HW64Q8G6G (Everolimus)
SB  - IM
MH  - *Carcinoma, Renal Cell/drug therapy
MH  - *Drug-Related Side Effects and Adverse Reactions/drug therapy/epidemiology
MH  - Everolimus/adverse effects
MH  - Humans
MH  - *Hyperglycemia/chemically induced
MH  - Japan
MH  - *Kidney Neoplasms/drug therapy
MH  - *Lung Diseases, Interstitial/drug therapy
OTO - NOTNLM
OT  - Japanese Adverse Drug Event Report database
OT  - everolimus
OT  - post-event outcomes
OT  - renal cell carcinoma
OT  - time to onset
EDAT- 2022/03/23 06:00
MHDA- 2022/08/25 06:00
CRDT- 2022/03/22 20:11
PHST- 2022/02/21 00:00 [revised]
PHST- 2022/02/05 00:00 [received]
PHST- 2022/03/04 00:00 [accepted]
PHST- 2022/03/23 06:00 [pubmed]
PHST- 2022/08/25 06:00 [medline]
PHST- 2022/03/22 20:11 [entrez]
AID - 10.1111/jcpt.13648 [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2022 Aug;47(8):1173-1180. doi: 10.1111/jcpt.13648. Epub 2022 
      Mar 22.