PMID- 31819582
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220411
IS  - 1178-7015 (Print)
IS  - 1178-7015 (Electronic)
IS  - 1178-7015 (Linking)
VI  - 12
DP  - 2019
TI  - Real-World Safety And Effectiveness Of OnabotulinumtoxinA Treatment Of Crow's 
      Feet Lines And Glabellar Lines: Results Of A Korean Postmarketing Surveillance 
      Study.
PG  - 851-856
LID - 10.2147/CCID.S227493 [doi]
AB  - PURPOSE: OnabotulinumtoxinA is approved in the Republic of Korea for the 
      treatment of moderate-to-severe crow's feet lines (CFL) and glabellar lines (GL), 
      separately or in combination. We assessed safety and effectiveness of 
      onabotulinumtoxinA in real-world clinical practice. PATIENT AND METHODS: This 
      4-year postmarketing surveillance study was conducted in the Republic of Korea in 
      subjects with moderate-to-severe CFL. Subjects aged 18 to 75 years received 
      onabotulinumtoxinA injections for CFL alone or in combination with GL. Safety 
      assessments included adverse events (AEs), serious AEs (SAEs), and unexpected AEs 
      (not noted in Korean prescribing information). Investigators assessed 
      effectiveness via change from baseline in CFL. RESULTS: The full analysis set 
      comprised 695 subjects; 667 were in the safety set and 376 in the effectiveness 
      set. In the safety set, mean +/- SD age was 40.9+/-13.0 years; most subjects (87.3%) 
      were female. More subjects were treated for CFL (69.9%) than CFL and GL 
      simultaneously (30.1%). Eleven subjects experienced 14 AEs; 12 were mild in 
      severity and 11 resolved without sequelae. Two cases of injection site pain in 2 
      subjects each were deemed possibly related to onabotulinumtoxinA. One unexpected 
      SAE (acute renal failure) occurred in 1 subject (0.15%). All unexpected AEs (n=4) 
      were mild and considered unrelated to treatment. Overall change from baseline 
      showed CFL was improved in 375 subjects (99.7%) and unchanged in 1 subject 
      (0.3%). CONCLUSION: OnabotulinumtoxinA was well tolerated and effective for 
      treatment of CFL with or without GL in a real-world Korean population. No new 
      safety concerns were identified.
CI  - (c) 2019 Yi et al.
FAU - Yi, Dong-Jin
AU  - Yi DJ
AUID- ORCID: 0000-0003-1223-5694
AD  - BLS Clinic, Seoul, Republic of Korea.
FAU - Hwang, Seongjin
AU  - Hwang S
AD  - Fulore Clinic, Seoul, Republic of Korea.
FAU - Son, JunHyuk
AU  - Son J
AD  - Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, 
      Republic of Korea.
FAU - Yushmanova, Irina
AU  - Yushmanova I
AUID- ORCID: 0000-0001-9755-1893
AD  - Global Patient Safety and Epidemiology, Allergan plc, Irvine, CA, USA.
FAU - Anson Spenta, Krystal
AU  - Anson Spenta K
AUID- ORCID: 0000-0001-6443-3073
AD  - Global Medical Trial Management, Allergan plc, Irvine, CA, USA.
FAU - St Rose, Suzanne
AU  - St Rose S
AUID- ORCID: 0000-0001-9106-6539
AD  - Global Patient Safety and Epidemiology, Allergan Holdings Ltd, Marlow, 
      Buckinghamshire, UK.
LA  - eng
PT  - Journal Article
DEP - 20191119
PL  - New Zealand
TA  - Clin Cosmet Investig Dermatol
JT  - Clinical, cosmetic and investigational dermatology
JID - 101543449
PMC - PMC6875486
OTO - NOTNLM
OT  - Botox
OT  - aesthetics
OT  - botulinum toxins
OT  - skin aging
OT  - type A
COIS- IY, KAS, and SSt.R are employees of Allergan plc and may own stock/options in the 
      company. JHS has served as a lecturer for Alcon and Novartis and as a consultant 
      for Allergan plc. He also reports personal fees from Allergan, during the conduct 
      of the study and outside the submitted work. D-JY reports personal fees from 
      Allergan plc, during the conduct of the study; personal fees from Medytox, Hugel, 
      lnc., LG Chem, and Aesthetics, outside the submitted work. SH reports personal 
      fees from Allergan, during the conduct of the study; personal fees from Wonik, 
      outside the submitted work. The authors report no other conflicts of interest in 
      this work.
EDAT- 2019/12/11 06:00
MHDA- 2019/12/11 06:01
PMCR- 2019/11/19
CRDT- 2019/12/11 06:00
PHST- 2019/08/16 00:00 [received]
PHST- 2019/10/26 00:00 [accepted]
PHST- 2019/12/11 06:00 [entrez]
PHST- 2019/12/11 06:00 [pubmed]
PHST- 2019/12/11 06:01 [medline]
PHST- 2019/11/19 00:00 [pmc-release]
AID - 227493 [pii]
AID - 10.2147/CCID.S227493 [doi]
PST - epublish
SO  - Clin Cosmet Investig Dermatol. 2019 Nov 19;12:851-856. doi: 10.2147/CCID.S227493. 
      eCollection 2019.