Tags

Type your tag names separated by a space and hit enter

Efficacy and Safety of Sustained Release Donepezil High Dose versus Immediate Release Donepezil Standard Dose in Japanese Patients with Severe Alzheimer's Disease: A Randomized, Double-Blind Trial.
J Alzheimers Dis 2016; 52(1):345-57JA

Abstract

BACKGROUND

Donepezil is an established treatment for mild, moderate, and severe Alzheimer's disease (AD). An international study demonstrated superior efficacy of sustained release (SR) 23 mg/day donepezil over immediate release (IR) 10 mg/day donepezil for cognitive function, but not global function in moderate-to-severe AD.

OBJECTIVE

To demonstrate the superiority of SR 23 mg/day donepezil over IR 10 mg/day donepezil in Japanese patients with severe AD (SAD).

METHODS

In this multicenter, randomized, double-blind, parallel-group study, Japanese outpatients with SAD were randomly assigned to continue IR 10 mg/day or switch to SR 23 mg/day for 24 weeks. Endpoints included the Severe Impairment Battery (SIB), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus), and safety.

RESULTS

Overall, 166 and 185 patients were randomized to receive IR 10 mg/day and SR 23 mg/day, respectively. SR 23 mg/day was not statistically superior to IR 10 mg/day by SIB (least squares mean difference [LSMD]: 0.0; 95% confidence interval [CI]: -1.7, 1.8; p = 0.981) or CIBIC-plus (LSMD: 0.2; 95% CI: 0.0, 0.4; p = 0.080). Common adverse events in the SR 23 mg group were decreased appetite, vomiting, diarrhea, and contusion. Safety findings were consistent with known safety profiles of donepezil.

CONCLUSION

SR 23 mg/day donepezil was not superior to IR 10 mg/day donepezil regarding the efficacy endpoints for Japanese SAD. Considering that a 10 mg/day dose is approved for SAD in Japan, the present findings suggest that IR 10 mg/day donepezil is the optimal dosage for Japanese patients with SAD.

Authors+Show Affiliations

Tokyo Dementia Care Research and Training Center, Tokyo, Japan.Nippon Medical School Tama-Nagayama Hospital, Nippon Medical School, Tokyo, Japan.Eisai Co., Ltd., Tokyo, Japan.Eisai Co., Ltd., Tokyo, Japan.Eisai Co., Ltd., Tokyo, Japan.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26967222

Citation

Homma, Akira, et al. "Efficacy and Safety of Sustained Release Donepezil High Dose Versus Immediate Release Donepezil Standard Dose in Japanese Patients With Severe Alzheimer's Disease: a Randomized, Double-Blind Trial." Journal of Alzheimer's Disease : JAD, vol. 52, no. 1, 2016, pp. 345-57.
Homma A, Atarashi H, Kubota N, et al. Efficacy and Safety of Sustained Release Donepezil High Dose versus Immediate Release Donepezil Standard Dose in Japanese Patients with Severe Alzheimer's Disease: A Randomized, Double-Blind Trial. J Alzheimers Dis. 2016;52(1):345-57.
Homma, A., Atarashi, H., Kubota, N., Nakai, K., & Takase, T. (2016). Efficacy and Safety of Sustained Release Donepezil High Dose versus Immediate Release Donepezil Standard Dose in Japanese Patients with Severe Alzheimer's Disease: A Randomized, Double-Blind Trial. Journal of Alzheimer's Disease : JAD, 52(1), pp. 345-57. doi:10.3233/JAD-151149.
Homma A, et al. Efficacy and Safety of Sustained Release Donepezil High Dose Versus Immediate Release Donepezil Standard Dose in Japanese Patients With Severe Alzheimer's Disease: a Randomized, Double-Blind Trial. J Alzheimers Dis. 2016 03 11;52(1):345-57. PubMed PMID: 26967222.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Sustained Release Donepezil High Dose versus Immediate Release Donepezil Standard Dose in Japanese Patients with Severe Alzheimer's Disease: A Randomized, Double-Blind Trial. AU - Homma,Akira, AU - Atarashi,Hirotsugu, AU - Kubota,Naoki, AU - Nakai,Kenya, AU - Takase,Takao, PY - 2016/3/12/entrez PY - 2016/3/12/pubmed PY - 2017/1/28/medline KW - Alzheimer’s disease KW - Japan KW - cholinesterase inhibitors KW - donepezil KW - double-blind study SP - 345 EP - 57 JF - Journal of Alzheimer's disease : JAD JO - J. Alzheimers Dis. VL - 52 IS - 1 N2 - BACKGROUND: Donepezil is an established treatment for mild, moderate, and severe Alzheimer's disease (AD). An international study demonstrated superior efficacy of sustained release (SR) 23 mg/day donepezil over immediate release (IR) 10 mg/day donepezil for cognitive function, but not global function in moderate-to-severe AD. OBJECTIVE: To demonstrate the superiority of SR 23 mg/day donepezil over IR 10 mg/day donepezil in Japanese patients with severe AD (SAD). METHODS: In this multicenter, randomized, double-blind, parallel-group study, Japanese outpatients with SAD were randomly assigned to continue IR 10 mg/day or switch to SR 23 mg/day for 24 weeks. Endpoints included the Severe Impairment Battery (SIB), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus), and safety. RESULTS: Overall, 166 and 185 patients were randomized to receive IR 10 mg/day and SR 23 mg/day, respectively. SR 23 mg/day was not statistically superior to IR 10 mg/day by SIB (least squares mean difference [LSMD]: 0.0; 95% confidence interval [CI]: -1.7, 1.8; p = 0.981) or CIBIC-plus (LSMD: 0.2; 95% CI: 0.0, 0.4; p = 0.080). Common adverse events in the SR 23 mg group were decreased appetite, vomiting, diarrhea, and contusion. Safety findings were consistent with known safety profiles of donepezil. CONCLUSION: SR 23 mg/day donepezil was not superior to IR 10 mg/day donepezil regarding the efficacy endpoints for Japanese SAD. Considering that a 10 mg/day dose is approved for SAD in Japan, the present findings suggest that IR 10 mg/day donepezil is the optimal dosage for Japanese patients with SAD. SN - 1875-8908 UR - https://www.unboundmedicine.com/medline/citation/26967222/Efficacy_and_Safety_of_Sustained_Release_Donepezil_High_Dose_versus_Immediate_Release_Donepezil_Standard_Dose_in_Japanese_Patients_with_Severe_Alzheimer's_Disease:_A_Randomized_Double_Blind_Trial_ L2 - https://content.iospress.com/openurl?genre=article&id=doi:10.3233/JAD-151149 DB - PRIME DP - Unbound Medicine ER -