PMID- 32457692
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1664-2295 (Print)
IS  - 1664-2295 (Electronic)
IS  - 1664-2295 (Linking)
VI  - 11
DP  - 2020
TI  - Effectiveness and Safety of a Clonidine Adhesive Patch for Children With Tic 
      Disorders: Study in a Real-World Practice.
PG  - 361
LID - 10.3389/fneur.2020.00361 [doi]
LID - 361
AB  - Background: Real-world evidence includes data from retrospective/prospective 
      observational studies and observational registries, and provides insights beyond 
      those addressed by randomized controlled trials. This study aimed to evaluate the 
      effectiveness and safety of a clonidine adhesive patch (CAP) for children with 
      tic disorder (TD) in a real-world setting (RWS). Methods: This was an open-label, 
      non-interventional, post-marketing, observational study in a RWS. Children 
      diagnosed with TDs were enrolled from a pediatric neurology clinic in China, and 
      the change in tic symptom severity following 6 weeks pharmacologic treatments was 
      investigated using Yale Global Tic Severity Scale (YGTSS) during visits at weeks 
      0, 4, 8, and 12. Results: Of 150 patients, 76% (114/150) were male (age range, 
      3.03-14.24 years; mean, 8.11 +/- 2.48 years). Patients were divided into three 
      groups: tiapride (n = 94), CAP (n = 14), and CAP + tiapride (n = 42). The mean 
      YGTSS improved 11.02, 15.14, 11.13 points from baseline to posttreatment for 
      tiapride, CAP, and CAP + tiapride, respectively, but variance analysis showed 
      there was no significant difference in YGTSS related to different pharmacologic 
      intervention during subsequent visits at weeks 4, 8, and 12. Repeated measure 
      analysis showed there was no significant difference between different medication 
      types for reducing the YGTSS score (F = 0.553, P = 0.576). No serious adverse 
      events (AEs) occurred, and there was no significant difference in the prevalence 
      of AEs between the three groups. Conclusion: The CAP is effective and safe for TD 
      management in a RWS, because of the limitation of sample size and the period of 
      follow up, observational studies with longer-term outcomes, and larger sample 
      size are needed.
CI  - Copyright (c) 2020 Yang, Kang, Yu, Zhao and Zhang.
FAU - Yang, Chunsong
AU  - Yang C
AD  - Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second 
      Hospital, Sichuan University, Key Laboratory of Birth Defects and Related 
      Diseases of Women and Children (Sichuan University), Ministry of Education, 
      Chengdu, China.
AD  - Department of Health Policy and Management, West China School of Public Health, 
      and West China Fourth Hospital, Sichuan University, Chengdu, China.
FAU - Kang, BingYao
AU  - Kang B
AD  - Department of Pediatric Clinic, West China Second Hospital, Sichuan University, 
      Chengdu, China.
FAU - Yu, Dan
AU  - Yu D
AD  - Department of Children's Genetic Endocrinology and Metabolism, West China Second 
      Hospital, Sichuan University, Key Laboratory of Birth Defects and Related 
      Diseases of Women and Children (Sichuan University), Ministry of Education, 
      Chengdu, China.
FAU - Zhao, Li
AU  - Zhao L
AD  - Department of Health Policy and Management, West China School of Public Health, 
      and West China Fourth Hospital, Sichuan University, Chengdu, China.
FAU - Zhang, Lingli
AU  - Zhang L
AD  - Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second 
      Hospital, Sichuan University, Key Laboratory of Birth Defects and Related 
      Diseases of Women and Children (Sichuan University), Ministry of Education, 
      Chengdu, China.
LA  - eng
PT  - Journal Article
DEP - 20200508
PL  - Switzerland
TA  - Front Neurol
JT  - Frontiers in neurology
JID - 101546899
PMC - PMC7225288
OTO - NOTNLM
OT  - clonidine adhesive patch
OT  - effectiveness
OT  - real-world study
OT  - safety
OT  - tic disorders
EDAT- 2020/05/28 06:00
MHDA- 2020/05/28 06:01
PMCR- 2020/05/08
CRDT- 2020/05/28 06:00
PHST- 2019/11/07 00:00 [received]
PHST- 2020/04/14 00:00 [accepted]
PHST- 2020/05/28 06:00 [entrez]
PHST- 2020/05/28 06:00 [pubmed]
PHST- 2020/05/28 06:01 [medline]
PHST- 2020/05/08 00:00 [pmc-release]
AID - 10.3389/fneur.2020.00361 [doi]
PST - epublish
SO  - Front Neurol. 2020 May 8;11:361. doi: 10.3389/fneur.2020.00361. eCollection 2020.