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Donepezil 23 mg in Asian patients with moderate-to-severe Alzheimer's disease.

Abstract

BACKGROUND

Ethnic diversity between different populations may affect treatment safety and efficacy.

AIMS AND METHODS

A subanalysis to a global trial (study 326) was carried out to ascertain the safety and efficacy of donepezil 23 mg/day compared with donepezil 10 mg/day in Asian patients with moderate-to-severe Alzheimer's disease. Changes in cognition and global functioning were measured by the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), respectively, at week 24.

RESULTS

Cognitive improvement measured by SIB score was greater with donepezil 23 mg than with donepezil 10 mg (+1.36 vs -1.56]; difference, 2.92). There was no difference between the groups in global function measured by the CIBIC-Plus (3.94 and 3.95, respectively). Overall, 119 patients (82.1%) receiving donepezil 23 mg and 56 (71.8%) receiving donepezil 10 mg experienced ≥1 treatment emergent adverse events (TEAEs). In the donepezil 23 mg group, the incidence of TEAEs was higher among patients of lower weight (<55 kg) at baseline than in those of higher weight (64 of 75 patients [85.3%] vs 55 of 70 patients [78.5%]).

CONCLUSIONS

The benefits and risks associated with donepezil 23 mg in Asian patients are comparable to those of the global study population.

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  • Authors+Show Affiliations

    ,

    Department of Neurology, Konkuk University Hospital, Seoul, South Korea.

    ,

    Department of Neurology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.

    ,

    Department of Neurology, Clinical Neuroscience Center & Neurology, Seoul National University Bundang Hospita, Gyeonggi-do, South Korea.

    ,

    Department of Neurology, Dong-A University College of Medicine, Dong-A University Hospital, Busan, South Korea.

    ,

    Department of Pharmacology, National University of Singapore and Memory Aging and Cognition Center, National University Health System, Singapore, Singapore.

    ,

    Department of Neurology, Neuroscience Centre, AIIMS, New Delhi, India.

    ,

    Regional Medical Advisor, Eisai Pharmaceuticals India Pvt. Ltd., Mumbai, India.

    Clinical Development Eisai Co. Ltd., Tokyo, Japan.

    Source

    Acta neurologica Scandinavica 135:2 2017 Feb pg 252-256

    MeSH

    Aged
    Aged, 80 and over
    Alzheimer Disease
    Asian Continental Ancestry Group
    Cholinesterase Inhibitors
    Donepezil
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Indans
    Male
    Middle Aged
    Nausea
    Piperidines
    Severity of Illness Index
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    26923256

    Citation

    Han, S-H, et al. "Donepezil 23 Mg in Asian Patients With Moderate-to-severe Alzheimer's Disease." Acta Neurologica Scandinavica, vol. 135, no. 2, 2017, pp. 252-256.
    Han SH, Lee JH, Kim SY, et al. Donepezil 23 mg in Asian patients with moderate-to-severe Alzheimer's disease. Acta Neurol Scand. 2017;135(2):252-256.
    Han, S. H., Lee, J. H., Kim, S. Y., Park, K. W., Chen, C., Tripathi, M., ... Kubota, N. (2017). Donepezil 23 mg in Asian patients with moderate-to-severe Alzheimer's disease. Acta Neurologica Scandinavica, 135(2), pp. 252-256. doi:10.1111/ane.12571.
    Han SH, et al. Donepezil 23 Mg in Asian Patients With Moderate-to-severe Alzheimer's Disease. Acta Neurol Scand. 2017;135(2):252-256. PubMed PMID: 26923256.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Donepezil 23 mg in Asian patients with moderate-to-severe Alzheimer's disease. AU - Han,S-H, AU - Lee,J-H, AU - Kim,S Y, AU - Park,K W, AU - Chen,C, AU - Tripathi,M, AU - Dash,A, AU - Kubota,N, Y1 - 2016/02/29/ PY - 2016/01/28/accepted PY - 2016/3/1/pubmed PY - 2017/3/3/medline PY - 2016/3/1/entrez KW - Asia KW - alzheimer disease KW - cognition KW - donepezil SP - 252 EP - 256 JF - Acta neurologica Scandinavica JO - Acta Neurol. Scand. VL - 135 IS - 2 N2 - BACKGROUND: Ethnic diversity between different populations may affect treatment safety and efficacy. AIMS AND METHODS: A subanalysis to a global trial (study 326) was carried out to ascertain the safety and efficacy of donepezil 23 mg/day compared with donepezil 10 mg/day in Asian patients with moderate-to-severe Alzheimer's disease. Changes in cognition and global functioning were measured by the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), respectively, at week 24. RESULTS: Cognitive improvement measured by SIB score was greater with donepezil 23 mg than with donepezil 10 mg (+1.36 vs -1.56]; difference, 2.92). There was no difference between the groups in global function measured by the CIBIC-Plus (3.94 and 3.95, respectively). Overall, 119 patients (82.1%) receiving donepezil 23 mg and 56 (71.8%) receiving donepezil 10 mg experienced ≥1 treatment emergent adverse events (TEAEs). In the donepezil 23 mg group, the incidence of TEAEs was higher among patients of lower weight (<55 kg) at baseline than in those of higher weight (64 of 75 patients [85.3%] vs 55 of 70 patients [78.5%]). CONCLUSIONS: The benefits and risks associated with donepezil 23 mg in Asian patients are comparable to those of the global study population. SN - 1600-0404 UR - https://www.unboundmedicine.com/medline/citation/26923256/Donepezil_23_mg_in_Asian_patients_with_moderate_to_severe_Alzheimer's_disease_ L2 - https://doi.org/10.1111/ane.12571 DB - PRIME DP - Unbound Medicine ER -