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A multinational, randomised, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer's disease.
Int J Geriatr Psychiatry. 2004 Jan; 19(1):58-67.IJ

Abstract

OBJECTIVES

To compare directly, in the same patient cohort, the ease of use and tolerability of donepezil and galantamine in the treatment of Alzheimer's disease (AD), and investigate the effects of both treatments on cognition and activities of daily living (ADL).

METHODS

Patients with mild to moderate AD from 14 European centres were randomised to receive open-label donepezil (up to 10 mg once daily) or galantamine (up to 12 mg twice daily) for 12 weeks, according to the approved product labelling. Physicians and caregivers completed questionnaires rating satisfaction with treatment/ease of use in daily practice. Secondary assessments were the ADAS-cog, the MMSE, and the DAD scale to assess ADL. Tolerability was evaluated by reporting adverse events (AEs).

RESULTS

Both physicians and caregivers reported significantly greater overall satisfaction/ease of use for donepezil (n = 64) compared with galantamine (n = 56) at weeks 4, 12, and endpoint (week 12 LOCF; all p-values <0.05). Significantly greater improvements in cognition were also observed for donepezil versus galantamine on the ADAS-cog at Week 12 and endpoint (p-values <0.05). ADL improved significantly in the donepezil group compared with the galantamine group at weeks 4, 12, and endpoint (p-values <0.05). Most AEs were mild to moderate, however, 46% galantamine-treated patients reported gastrointestinal AEs vs 25% donepezil patients.

CONCLUSIONS

Physician and caregiver ease of use/satisfaction scores, and assessments of cognition and ADL, showed significant benefits for donepezil compared with galantamine in this direct comparative trial. Both treatments were well tolerated, with more gastrointestinal AEs reported for galantamine vs donepezil.

Authors+Show Affiliations

Research Institute for the Care of the Elderly, St Martin's Hospital, Bath, UK. r.w.jones@bath.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

14716700

Citation

Jones, Roy W., et al. "A Multinational, Randomised, 12-week Study Comparing the Effects of Donepezil and Galantamine in Patients With Mild to Moderate Alzheimer's Disease." International Journal of Geriatric Psychiatry, vol. 19, no. 1, 2004, pp. 58-67.
Jones RW, Soininen H, Hager K, et al. A multinational, randomised, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer's disease. Int J Geriatr Psychiatry. 2004;19(1):58-67.
Jones, R. W., Soininen, H., Hager, K., Aarsland, D., Passmore, P., Murthy, A., Zhang, R., & Bahra, R. (2004). A multinational, randomised, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer's disease. International Journal of Geriatric Psychiatry, 19(1), 58-67.
Jones RW, et al. A Multinational, Randomised, 12-week Study Comparing the Effects of Donepezil and Galantamine in Patients With Mild to Moderate Alzheimer's Disease. Int J Geriatr Psychiatry. 2004;19(1):58-67. PubMed PMID: 14716700.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multinational, randomised, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer's disease. AU - Jones,Roy W, AU - Soininen,Hilkka, AU - Hager,Klaus, AU - Aarsland,Dag, AU - Passmore,Peter, AU - Murthy,Anita, AU - Zhang,Richard, AU - Bahra,Ranbir, PY - 2004/1/13/pubmed PY - 2004/4/2/medline PY - 2004/1/13/entrez SP - 58 EP - 67 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 19 IS - 1 N2 - OBJECTIVES: To compare directly, in the same patient cohort, the ease of use and tolerability of donepezil and galantamine in the treatment of Alzheimer's disease (AD), and investigate the effects of both treatments on cognition and activities of daily living (ADL). METHODS: Patients with mild to moderate AD from 14 European centres were randomised to receive open-label donepezil (up to 10 mg once daily) or galantamine (up to 12 mg twice daily) for 12 weeks, according to the approved product labelling. Physicians and caregivers completed questionnaires rating satisfaction with treatment/ease of use in daily practice. Secondary assessments were the ADAS-cog, the MMSE, and the DAD scale to assess ADL. Tolerability was evaluated by reporting adverse events (AEs). RESULTS: Both physicians and caregivers reported significantly greater overall satisfaction/ease of use for donepezil (n = 64) compared with galantamine (n = 56) at weeks 4, 12, and endpoint (week 12 LOCF; all p-values <0.05). Significantly greater improvements in cognition were also observed for donepezil versus galantamine on the ADAS-cog at Week 12 and endpoint (p-values <0.05). ADL improved significantly in the donepezil group compared with the galantamine group at weeks 4, 12, and endpoint (p-values <0.05). Most AEs were mild to moderate, however, 46% galantamine-treated patients reported gastrointestinal AEs vs 25% donepezil patients. CONCLUSIONS: Physician and caregiver ease of use/satisfaction scores, and assessments of cognition and ADL, showed significant benefits for donepezil compared with galantamine in this direct comparative trial. Both treatments were well tolerated, with more gastrointestinal AEs reported for galantamine vs donepezil. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/14716700/A_multinational_randomised_12_week_study_comparing_the_effects_of_donepezil_and_galantamine_in_patients_with_mild_to_moderate_Alzheimer's_disease_ L2 - https://doi.org/10.1002/gps.1038 DB - PRIME DP - Unbound Medicine ER -