A feasibility study evaluating lisdexamfetamine dimesylate for the treatment of adults with bulimia nervosa.
bulimia nervosa
lisdexamfetamine dimesylate
pharmacological treatment
stimulants
Journal
The International journal of eating disorders
ISSN: 1098-108X
Titre abrégé: Int J Eat Disord
Pays: United States
ID NLM: 8111226
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
revised:
20
01
2021
received:
03
10
2020
accepted:
20
01
2021
pubmed:
4
2
2021
medline:
16
10
2021
entrez:
3
2
2021
Statut:
ppublish
Résumé
This study examined the feasibility, safety, and potential efficacy of lisdexamfetamine (LDX) as a treatment for adults with bulimia nervosa (BN). An open-label 8-week feasibility study was conducted in participants with BN. Enrollment rate, dropout rate, safety outcomes, and eating disorder symptom change were examined. Eighteen of 23 participants completed the study per protocol. There was no participant-initiated dropout due to adverse drug reactions and no severe and unexpected adverse drug reactions. An average increase in heart rate of 12.1 beats/min was observed. There was a mean weight reduction of 2.1 kg and one participant was withdrawn for clinically significant weight loss. In the intent-to-treat sample, there were reductions in objective binge episodes and compensatory behaviors from Baseline to Post/End-of-Treatment (mean difference = -29.83, 95% confidence interval: -43.38 to -16.27; and mean difference = -33.78, 95% confidence interval: -48.74 to -18.82, respectively). Results of this study indicate that a randomized controlled trial would be feasible with close monitoring of certain safety parameters (especially over a longer time period as long-term safety is unknown). However, the results should not be used as evidence for clinicians to prescribe LDX to individuals with BN before its efficacy and safety are properly tested. NCT03397446.
Substances chimiques
Central Nervous System Stimulants
0
Lisdexamfetamine Dimesylate
SJT761GEGS
Banques de données
ClinicalTrials.gov
['NCT03397446']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
872-878Informations de copyright
© 2021 Wiley Periodicals LLC.
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