Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease.
Int J Geriatr Psychiatry. 2007 Aug; 22(8):806-12.IJ

Abstract

OBJECTIVE

This 132-week, open-label extension study assessed the long-term efficacy and safety of donepezil in 579 patients with mild to moderate Alzheimer's disease (AD) who had previously participated in a 24-week double-blind study of 5 or 10 mg/day donepezil vs placebo.

METHOD

Patients enrolled in the present study had a 6-week single-blind placebo washout period followed by treatment with donepezil 5 mg/day for 6 weeks with an optional increase in dosage to 10 mg/day between weeks 6 and 32.

RESULTS

After 6 weeks of open-label treatment with donepezil 5 mg/day, mean Alzheimer's Disease Assessment Scale -- cognitive subscale scores (ADAS-cog) improved by approximately two points, while after 12 weeks of open-label treatment (with a majority of patients receiving 10 mg/day), the mean ADAS-cog score was 1 point better than the score at the end of the placebo washout period. Scores then declined gradually over the remainder of the study. Mean changes in Clinical Dementia Rating-Sum of Boxes scores showed slight improvement over the first 12 weeks of open-label treatment and then slowly declined for the remainder of the study period. Donepezil was well tolerated over the entire 162-week study period. Overall, 85% of patients experienced at least one adverse event (AE). The most common included diarrhoea (12%), nausea (11%), infection (11%) and accidental injury (10%). Some patients discontinued the study due to AEs (15%).

CONCLUSIONS

These results support the conclusion that donepezil is safe and effective for the long-term treatment of patients with mild to moderate AD.

Authors+Show Affiliations

University of Manchster, Manchester, UK. alistair.burns@manchester.ac.ukNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17199235

Citation

Burns, A, et al. "Efficacy and Safety of Donepezil Over 3 Years: an Open-label, Multicentre Study in Patients With Alzheimer's Disease." International Journal of Geriatric Psychiatry, vol. 22, no. 8, 2007, pp. 806-12.
Burns A, Gauthier S, Perdomo C. Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease. Int J Geriatr Psychiatry. 2007;22(8):806-12.
Burns, A., Gauthier, S., & Perdomo, C. (2007). Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease. International Journal of Geriatric Psychiatry, 22(8), 806-12.
Burns A, Gauthier S, Perdomo C. Efficacy and Safety of Donepezil Over 3 Years: an Open-label, Multicentre Study in Patients With Alzheimer's Disease. Int J Geriatr Psychiatry. 2007;22(8):806-12. PubMed PMID: 17199235.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease. AU - Burns,A, AU - Gauthier,S, AU - Perdomo,C, PY - 2007/1/3/pubmed PY - 2007/12/13/medline PY - 2007/1/3/entrez SP - 806 EP - 12 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 22 IS - 8 N2 - OBJECTIVE: This 132-week, open-label extension study assessed the long-term efficacy and safety of donepezil in 579 patients with mild to moderate Alzheimer's disease (AD) who had previously participated in a 24-week double-blind study of 5 or 10 mg/day donepezil vs placebo. METHOD: Patients enrolled in the present study had a 6-week single-blind placebo washout period followed by treatment with donepezil 5 mg/day for 6 weeks with an optional increase in dosage to 10 mg/day between weeks 6 and 32. RESULTS: After 6 weeks of open-label treatment with donepezil 5 mg/day, mean Alzheimer's Disease Assessment Scale -- cognitive subscale scores (ADAS-cog) improved by approximately two points, while after 12 weeks of open-label treatment (with a majority of patients receiving 10 mg/day), the mean ADAS-cog score was 1 point better than the score at the end of the placebo washout period. Scores then declined gradually over the remainder of the study. Mean changes in Clinical Dementia Rating-Sum of Boxes scores showed slight improvement over the first 12 weeks of open-label treatment and then slowly declined for the remainder of the study period. Donepezil was well tolerated over the entire 162-week study period. Overall, 85% of patients experienced at least one adverse event (AE). The most common included diarrhoea (12%), nausea (11%), infection (11%) and accidental injury (10%). Some patients discontinued the study due to AEs (15%). CONCLUSIONS: These results support the conclusion that donepezil is safe and effective for the long-term treatment of patients with mild to moderate AD. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/17199235/Efficacy_and_safety_of_donepezil_over_3_years:_an_open_label_multicentre_study_in_patients_with_Alzheimer's_disease_ L2 - https://doi.org/10.1002/gps.1746 DB - PRIME DP - Unbound Medicine ER -