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Adverse Events With Sustained-Release Donepezil in Alzheimer Disease: Relation to Body Mass Index

Authors
Lee, ChunsooLee, KyungsangYu, HyewonRyu, Seung-HoMoon, Seok WooHan, ChangsuLee, Jun-YoungLee, Young MinKim, Shin-GyeomKim, Ki WoongLee, Dong WooKim, Seong YoonLee, Sang-YeolBae, Jae NamJung, Young-EunKim, Jeong LanKim, Byung-SooShin, Il-SeonKim, Young HoonKim, Bong JoKang, Hyo ShinMyung, WoojaeCarroll, Bernard J.Kim, Doh Kwan
Issue Date
8월-2017
Publisher
LIPPINCOTT WILLIAMS & WILKINS
Keywords
adverse effects; Alzheimer disease; body mass index; clinical trial; donepezil
Citation
JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, v.37, no.4, pp.401 - 404
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
Volume
37
Number
4
Start Page
401
End Page
404
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/82752
DOI
10.1097/JCP.0000000000000726
ISSN
0271-0749
Abstract
Purpose/Background Sustained-release, high-dose (23 mg/d) donepezil has been approved for treatment of moderate to severe Alzheimer disease (AD). Based on a previous clinical trial, body weight of less than 55 kg is a risk factor for adverse events with donepezil 23 mg/d treatment in global population. Methods/Procedures To clarify whether this finding is consistent across ethnic groups that vary in absolute body mass, we recruited Korean patients aged 45 to 90 years with moderate to severe AD who had been receiving standard donepezil immediate release 10 mg/d for at least 3 months. After screening, we analyzed a final cohort of 166 patients who received donepezil 23 mg/d for 24 weeks to compare the occurrence of treatment-emergent adverse events (TEAEs) between patients with high versus low body mass index (BMI) based on the World Health Organization overweight criteria for Asian populations (23 kg/m(2)). Findings/Results Treatment-emergent adverse events were reported by 79.45% of patients in the lower BMI group and 58.06% of patients in the higher BMI group (odds ratio, 2.79; 95% confidence interval, 1.39-5.63; (2) = 7.58, P = 0.006). In a multivariable survival analysis, the group with lower BMI showed a higher occurrence of TEAEs (hazard ratio, 1.83; 95% confidence interval, 1.25-2.68; P = 0.002). Implications/Conclusions In Korean patients with moderate to severe AD receiving high-dose donepezil over 24 weeks, TEAEs were significantly more common in those with lower BMI (not clinically overweight), especially nausea. This finding may inform clinical practice for Asian patients.
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