Brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease: A 12-week, active-treatment, extension trial.

Autor:	Behl S; Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Slomkowski M; Clinical Management, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Chen D; Biostatistics, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Chang D; Biostatistics, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Hefting N; Global Clinical Development, H. Lundbeck A/S, Valby, Denmark., Lee D; Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Shah A; Global Medical Safety, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Estilo A; Global Medical Safety, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA., Kalu U; Global Medical Safety, Lundbeck LLC, Deerfield, IL, USA., Hobart M; Global R&D, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.
Jazyk:	angličtina
Zdroj:	Journal of Alzheimer's disease : JAD [J Alzheimers Dis] 2024 Nov; Vol. 102 (2), pp. 520-529. Date of Electronic Publication: 2024 Nov 13.
DOI:	10.3233/JAD-240491
Abstrakt:	Background: A 12-week randomized controlled trial demonstrated that brexpiprazole is efficacious for treating agitation in patients with dementia due to Alzheimer's disease. Objective: To assess the long-term safety and tolerability of brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease. Methods: This 12-week, active-treatment (oral brexpiprazole 2 or 3 mg/day) extension trial ran from October 2018-September 2022 at 66 sites in Europe/US. Patients with agitation in dementia due to Alzheimer's disease in a care facility/community-based setting who completed the randomized trial were eligible (N = 259 enrolled/analyzed for safety; 88.4% completed). Stable Alzheimer's disease medications were permitted. The primary safety endpoint was the frequency and severity of treatment-emergent adverse events (TEAEs). Change in Cohen-Mansfield Agitation Inventory (CMAI) total score was an exploratory efficacy endpoint. Results: Mean (SD) age was 74.3 (7.6) years, 145 patients (56.0%) were female, and 248 (95.8%) were White. TEAEs were reported by 67 patients (25.9%), most commonly headache (3.5%) and fall (2.3%). Most TEAEs were mild or moderate in severity; 5 patients (1.9%) reported a severe TEAE, including 3 severe falls attributed to tripping, misjudging sitting, or dehydration. Twelve patients (4.6%) discontinued due to TEAEs. No patients died. Mean CMAI total score improved by 9.1 points over 12 weeks. Conclusions: Considering the randomized and extension trials together, brexpiprazole 2 or 3 mg was generally well tolerated for up to 24 weeks in elderly patients with agitation associated with dementia due to Alzheimer's disease. Patients showed continued improvement in agitation. Clinicaltrials.gov Identifier: NCT03594123 (registration date: July 11, 2018). Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Saloni Behl, Daniel Lee, and Alvin Estilo were full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. at the time of this work. Mary Slomkowski, Dalei Chen, Denise Chang, Alpesh Shah, and Mary Hobart are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. Nanco Hefting is a full-time employee of H. Lundbeck A/S. Uwa Kalu is a full-time employee of Lundbeck LLC.
Databáze:	MEDLINE
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