PMID- 38137075
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231225
IS  - 2076-3425 (Print)
IS  - 2076-3425 (Electronic)
IS  - 2076-3425 (Linking)
VI  - 13
IP  - 12
DP  - 2023 Nov 24
TI  - Efficacy and Safety of SPN-812 (Extended-Release Viloxazine) in Children and 
      Adolescents with Attention-Deficit/Hyperactivity Disorder: A Systematic Review 
      and Meta-Analysis.
LID - 10.3390/brainsci13121627 [doi]
LID - 1627
AB  - BACKGROUND: SPN-812 has been approved for attention-deficit/hyperactivity 
      disorder (ADHD) treatment in children and adolescents. OBJECTIVE: We aimed to 
      analyze the efficacy and safety of different doses of SPN-812 for ADHD pediatric 
      patients of different ages, verify its clinical efficacy, and evaluate its 
      safety. METHODS: Up until 30 August 2023, randomized controlled trials (RCTs) 
      were searched in EMBASE, MEDLINE, the Cochrane Library, and clinicaltrials.gov to 
      evaluate different doses of SPN-812 and a placebo. RESULTS: We pooled 1619 
      patients from five RCTs with a duration of 6-8 weeks. Patients (6-17 years old) 
      in SPN-812 (100, 200, and 400 mg/d) groups were superior to the control group in 
      all efficacy outcomes with lower attention-deficit/hyperactivity disorder rating 
      scale-5 (ADHD-RS-5), Conners 3-parent short form composite T score (Conners 
      3-PS), Weiss functional impairment rating scale-parent (WFIRS-P), and increased 
      clinical global impression-improvement (CGI-I) score (both p < 0.05). At the same 
      time, only SPN-812 300 mg/d did not show a significantly high risk of the adverse 
      events (AEs) such as somnolence and decreased appetite (p = 0.09). There was no 
      significant difference between placebo and SPN-812 groups (100, 200, and 400 
      mg/d) in serious adverse events (SAEs) such as syncope. The subgroup analyses 
      showed that, both in children and adolescents subgroups, SPN-812 showed better 
      efficacy than the placebo. The two age subgroups showed a significantly higher 
      risk of AEs and an insignificant risk of SAEs than the placebo. CONCLUSION: At 
      present, SPN-812 (100, 200, and 400 mg/d) is superior to the corresponding 
      control in efficacy measures. However, the safety problem cannot be ignored.
FAU - Tan, Xin
AU  - Tan X
AD  - Department of Neurology, The Affiliated Suzhou Hospital of Nanjing Medical 
      University, Suzhou Municipal Hospital, Suzhou 215000, China.
FAU - Xu, Yuejuan
AU  - Xu Y
AD  - Department of Respiratory Medicine, Children's Hospital of Wujiang District, 
      Children's Hospital of Soochow University, Suzhou 215025, China.
FAU - Wang, Shixin
AU  - Wang S
AD  - Department of Neurosurgery& Brain and Nerve Research Laboratory, The First 
      Affiliated Hospital of Soochow University, Suzhou 215006, China.
FAU - Li, Jiaxuan
AU  - Li J
AD  - Department of Neurosurgery& Brain and Nerve Research Laboratory, The First 
      Affiliated Hospital of Soochow University, Suzhou 215006, China.
FAU - Hu, Chunxia
AU  - Hu C
AD  - Department of Respiratory Medicine, Children's Hospital of Wujiang District, 
      Children's Hospital of Soochow University, Suzhou 215025, China.
FAU - Chen, Zhouqing
AU  - Chen Z
AUID- ORCID: 0000-0001-7517-7036
AD  - Department of Neurosurgery& Brain and Nerve Research Laboratory, The First 
      Affiliated Hospital of Soochow University, Suzhou 215006, China.
FAU - Cheng, Qingzhang
AU  - Cheng Q
AD  - Department of Neurology, The Affiliated Suzhou Hospital of Nanjing Medical 
      University, Suzhou Municipal Hospital, Suzhou 215000, China.
FAU - Wang, Zhong
AU  - Wang Z
AUID- ORCID: 0000-0002-7342-0845
AD  - Department of Neurosurgery& Brain and Nerve Research Laboratory, The First 
      Affiliated Hospital of Soochow University, Suzhou 215006, China.
AD  - Department of Neurosurgery, The First Affiliated Hospital of Soochow University, 
      Suzhou 215006, China.
LA  - eng
GR  - GSKY20210207/Nanjing Medical University/
GR  - GSWS2019002/Suzhou Health Talents Training Project/
PT  - Journal Article
PT  - Review
DEP - 20231124
PL  - Switzerland
TA  - Brain Sci
JT  - Brain sciences
JID - 101598646
PMC - PMC10742293
OTO - NOTNLM
OT  - SPN-812
OT  - attention-deficit/hyperactivity disorder
OT  - pediatric patients
OT  - systematic review
OT  - viloxazine
COIS- The authors state that they do not have any competing interests.
EDAT- 2023/12/23 12:43
MHDA- 2023/12/23 12:44
PMCR- 2023/11/24
CRDT- 2023/12/23 01:07
PHST- 2023/10/28 00:00 [received]
PHST- 2023/11/19 00:00 [revised]
PHST- 2023/11/22 00:00 [accepted]
PHST- 2023/12/23 12:44 [medline]
PHST- 2023/12/23 12:43 [pubmed]
PHST- 2023/12/23 01:07 [entrez]
PHST- 2023/11/24 00:00 [pmc-release]
AID - brainsci13121627 [pii]
AID - brainsci-13-01627 [pii]
AID - 10.3390/brainsci13121627 [doi]
PST - epublish
SO  - Brain Sci. 2023 Nov 24;13(12):1627. doi: 10.3390/brainsci13121627.