PMID- 31415382
OWN - NLM
STAT- MEDLINE
DCOM- 20190827
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 98
IP  - 33
DP  - 2019 Aug
TI  - Pattern of adverse events induced by aflibercept and ranibizumab: A nationwide 
      spontaneous adverse event reporting database, 2007-2016.
PG  - e16785
LID - 10.1097/MD.0000000000016785 [doi]
LID - e16785
AB  - Data regarding the safety of anti-vascular endothelial growth factor (anti-VEGF) 
      treatment is limited.To compare the adverse events (AEs) induced by aflibercept 
      and ranibizumab using a spontaneous reporting system and determine the signals.We 
      used data from the Korea Institute of Drug Safety & Risk Management-Korea Adverse 
      Event Reporting System Database (KIDS-KD), collected between 2007 and 2016. 
      Differences in patient demographics, report type, reporter, causality, and 
      serious-AEs between aflibercept and ranibizumab were compared. Metrics including 
      proportional reporting ratio (PRR), reporting odds ratio (ROR), and information 
      component (IC), were used to compare signals with the AEs on the drug labels in 
      the United States of America and Korea. Logistic regression analysis was 
      performed to identify AEs that are more likely to occur with drug use.A total of 
      32 aflibercept and 103 ranibizumab cases of AEs were identified. The proportion 
      of AEs that were reported voluntarily was higher with aflibercept (50.5%) use 
      than ranibizumab (4.9%), whereas the AEs reported by post-marketing surveillance 
      were higher with ranibizumab (46.6%) use than aflibercept (31.3%). The percentage 
      of AEs in patients >60 years old, reports by consumers, and the ratio of SAEs to 
      AEs associated with aflibercept (84. %, 9.4%, and 75.0%, respectively) were 
      higher than those of ranibizumab (77.7%, 1.9%, and 19.4%, respectively). The 
      number of newly detected AEs after aflibercept and ranibizumab treatment was 3 
      and 8, respectively. Among these, conjunctivitis and medicine ineffective were 
      not included on the aflibercept and ranibizumab labels, respectively. 
      Endophthalmitis (OR 6.96, 95% CI 2.74-17.73) was more likely to be reported in 
      patients with aflibercept than in patients without aflibercept, whereas medicine 
      ineffective (OR 18.49, 95% CI 2.39-143.29) and retinal disorder (OR 7.03, 95% CI 
      1.60-30.96) were more likely to be reported in patients with ranibizumab than in 
      patients without ranibizumab.New signals have been identified for aflibercept and 
      ranibizumab. Further research is necessary to evaluate the causality of AEs that 
      were detected as signals in this study.
FAU - Ha, Dongmun
AU  - Ha D
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, 
      Gyeonggi-do, South Korea.
FAU - Choi, So-Ra
AU  - Choi SR
FAU - Kwon, Yongmin
AU  - Kwon Y
FAU - Park, Han-Heui
AU  - Park HH
FAU - Shin, Ju-Young
AU  - Shin JY
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - 15C2VL427D (aflibercept)
RN  - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
RN  - ZL1R02VT79 (Ranibizumab)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Angiogenesis Inhibitors/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ranibizumab/*adverse effects
MH  - Receptors, Vascular Endothelial Growth Factor
MH  - Recombinant Fusion Proteins/*adverse effects
MH  - Republic of Korea/epidemiology
MH  - Vascular Endothelial Growth Factor A/*antagonists & inhibitors
MH  - Young Adult
PMC - PMC6831246
EDAT- 2019/08/16 06:00
MHDA- 2019/08/28 06:00
PMCR- 2019/08/16
CRDT- 2019/08/16 06:00
PHST- 2019/08/16 06:00 [entrez]
PHST- 2019/08/16 06:00 [pubmed]
PHST- 2019/08/28 06:00 [medline]
PHST- 2019/08/16 00:00 [pmc-release]
AID - 00005792-201908160-00036 [pii]
AID - MD-D-19-02038 [pii]
AID - 10.1097/MD.0000000000016785 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2019 Aug;98(33):e16785. doi: 10.1097/MD.0000000000016785.