Evaluating the likelihood to be helped or harmed after treatment with viloxazine extended-release in children and adolescents with attention-deficit/hyperactivity disorder.
Journal
International journal of clinical practice
ISSN: 1742-1241
Titre abrégé: Int J Clin Pract
Pays: India
ID NLM: 9712381
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
revised:
16
04
2021
received:
12
02
2021
accepted:
03
05
2021
pubmed:
11
5
2021
medline:
24
7
2021
entrez:
10
5
2021
Statut:
ppublish
Résumé
When clinicians evaluate potential medications for their patients, they must weigh the probability of a treatment's benefits against the possible risks. To this end, the present analyses evaluate the novel nonstimulant viloxazine extended-release (viloxazine ER) using measures of effect size to describe the potential benefits of its treatment in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) as well as the risk of discontinuation because of intolerable adverse events. These post hoc analyses use pooled data from four pivotal Phase 3 trials in paediatric patients treated with viloxazine ER. The Likelihood to be Helped or Harmed (LHH) effect size measure was calculated to describe the probability of patients benefiting from treatment vs discontinuing. The Number Needed to Treat (NNT) was calculated from frequently used thresholds of response. The Number Needed to Harm (NNH) was calculated using discontinuations because of adverse events. LHH values for viloxazine ER ranged from 5 to 13, suggesting that subjects were 5-13 times more likely to benefit from, rather than discontinue, viloxazine ER treatment. Specifically, NNT values for viloxazine ER treatment ranged from 6 to 7. NNH values for viloxazine ER treatment ranged from 31 to 74. By convention, single-digit NNTs (<10) suggest the intervention is potentially useful, while NNH values ≥10 for adverse events suggest it is potentially safe or tolerable. These results indicate that patients with ADHD are likely to benefit from treatment with viloxazine ER, and are unlikely to discontinue, as viloxazine ER treatment was associated with favourable LHH, NNT, and NNH values. Clinicaltrials.gov: NCT03247530, NCT03247543, NCT03247517, NCT03247556.
Identifiants
pubmed: 33971070
doi: 10.1111/ijcp.14330
pmc: PMC8365735
doi:
Substances chimiques
Viloxazine
5I5Y2789ZF
Banques de données
ClinicalTrials.gov
['NCT03247517', 'NCT03247543', 'NCT03247556', 'NCT03247530']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e14330Subventions
Organisme : Supernus Pharmaceuticals, Inc
Informations de copyright
© 2021 Supernus Pharmaceuticals Inc. International Journal of Clinical Practice published by John Wiley & Sons Ltd.
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