Assessment of centanafadine in adults with ADHD: a matching adjusted indirect comparison versus methylphenidate hydrochloride extended release (Concerta).
Autor: | Schein J; Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA., Cloutier M; Analysis Group, Inc, Montréal, QC, Canada., Gauthier-Loiselle M; Analysis Group, Inc, Montréal, QC, Canada., Catillon M; Analysis Group, Inc, New York, NY, USA., Xu C; Analysis Group, Inc, New York, NY, USA., Qu A; Analysis Group, Inc, New York, NY, USA., Childress A; Psychiatry and Behavioral Medicine, Center for Psychiatry and Behavioral Medicine, Las Vegas, NV, USA. |
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Jazyk: | angličtina |
Zdroj: | Current medical research and opinion [Curr Med Res Opin] 2024 Aug; Vol. 40 (8), pp. 1397-1406. Date of Electronic Publication: 2024 Jul 10. |
DOI: | 10.1080/03007995.2024.2373883 |
Abstrakt: | Objective: To compare safety and efficacy of centanafadine versus methylphenidate hydrochloride extended release (ER; Concerta) in adults with ADHD. Methods: Without head-to-head trials, anchored matching-adjusted indirect comparisons (MAIC) of adverse event rates reported across trials and mean change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score between centanafadine and methylphenidate hydrochloride ER were conducted. Pooled patient-level data from two centanafadine trials (NCT03605680/NCT03605836) and aggregate data from one published methylphenidate hydrochloride ER trial (NCT00937040) were used. Characteristics of individual patients from the centanafadine trials were matched to aggregate baseline characteristics from the methylphenidate hydrochloride ER trial using propensity score weighting. A sensitivity analysis assessed the robustness of the results to the capping of extreme weights (i.e. >99 th percentile). Results: Compared with methylphenidate hydrochloride ER, centanafadine was associated with significantly lower risk of dry mouth (risk difference [RD] in percentage points: -11.95), initial insomnia (-11.10), decreased appetite (-8.05), anxiety (-5.39), palpitations (-5.25), and feeling jittery (-4.73) though a significantly smaller reduction in AISRS score (4.16-point). In the sensitivity analysis, the safety results were consistent with the primary analysis but there was no significant difference in efficacy between centanafadine and methylphenidate hydrochloride ER. Conclusion: In this MAIC, centanafadine had better safety and possibly lower efficacy than methylphenidate hydrochloride ER. While safety results were robust across analyses, there was no efficacy difference between centanafadine and methylphenidate hydrochloride ER in the sensitivity analysis. Considering its favorable safety profile, centanafadine may be preferred among patients for whom treatment-related adverse events are a concern. |
Databáze: | MEDLINE |
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