Evaluating the likelihood to be helped or harmed after treatment with viloxazine extended-release in children and adolescents with attention-deficit/hyperactivity disorder.

Autor:	Nasser A; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Kosheleff AR; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Hull JT; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Liranso T; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Qin P; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Busse GD; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Fava M; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., Maletic V; Department of Psychiatry/Behavioral Science, University of South Carolina School of Medicine, Greenville, SC, USA., Rubin J; Supernus Pharmaceuticals, Inc., Rockville, MD, USA., Lopez F; Children's Developmental Center, Winter Park, FL, USA.
Jazyk:	angličtina
Zdroj:	International journal of clinical practice [Int J Clin Pract] 2021 Aug; Vol. 75 (8), pp. e14330. Date of Electronic Publication: 2021 May 26.
DOI:	10.1111/ijcp.14330
Abstrakt:	Aims: 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. Methods: 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. Results: 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. Conclusions: 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. (© 2021 Supernus Pharmaceuticals Inc. International Journal of Clinical Practice published by John Wiley & Sons Ltd.)
Databáze:	MEDLINE
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