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A long-term comparison of galantamine and donepezil in the treatment of Alzheimer's disease

Lilienfeld, Sean; Kershaw, Paul; Coles, Hilary; Howe, Ian; Truyen, Luc; Bullock, Roger; Zhu, Young; Wilcock, Gordon

Authors

Sean Lilienfeld

Paul Kershaw

Hilary Coles

Ian Howe

Luc Truyen

Roger Bullock

Young Zhu

Gordon Wilcock



Abstract

Objective: To compare the long-term efficacy and safety of galantamine 24 mg/day and donepezil 10 mg/day in patients with Alzheimer's disease. Patients and Study Design: This was a rater-blinded, randomised, parallel-group multicentre study (18 outpatient clinics) in the UK. 182 patients (69 male, 113 female) with Alzheimer's disease were randomised to galantamine (n = 94) or donepezil (n = 88) for 52 weeks. Main outcome measures: The effects of galantamine and donepezil on function using the Bristol Activities of Daily Living Scale (BrADL); cognition using the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11); behaviour using the Neuropsychiatric Inventory (NPI); caregiver burden using the Screen for Caregiver Burden; and safety were assessed. Results: BrADL total scores showed no significant difference between treatment groups in mean change from baseline to week 52. In the total population, in terms of cognition, galantamine patients' scores on the MMSE at week 52 did not differ significantly from baseline (-0.52 ± 0.39, p < 0.5 vs baseline), whereas donepezil patients' scores deteriorated significantly from baseline (-1.58 ± 0.42, p < 0.0005 vs baseline). The between-group difference in MMSE change, which showed a trend for superiority of galantamine, did not reach statistical significance (p ≤ 0.1). In the ADAS-cog/11 analysis, between-group differences for the total population were not significant, whereas galantamine-treated patients with MMSE scores of 12-18 demonstrated an increase (worsening) in the ADAS-cog/11 score of 1.61 ± 0.80 versus baseline, compared with an increase of 4.08 ± 0.84 for patients treated with donepezil, with a significant between-group difference in favour of galantamine (p ≤ 0.05). More caregivers of patients receiving galantamine reported reductions in burden compared with donepezil. Changes from baseline in NPI were similar for both treatments. Both treatments were well tolerated; most adverse events were transient and of mild-to-moderate intensity, and were consistent with the findings of previous clinical trials. Conclusions: Significant advantages were found in the treatment response to galantamine (versus donepezil) on cognition as measured by response rates on the MMSE and ADAS-cog/11.

Citation

Kershaw, P., Lilienfeld, S., Coles, H., Howe, I., Truyen, L., Bullock, R., …Wilcock, G. (2003). A long-term comparison of galantamine and donepezil in the treatment of Alzheimer's disease. Drugs and Aging, 20(10), 777-789. https://doi.org/10.2165/00002512-200320100-00006

Journal Article Type Article
Publication Date Aug 26, 2003
Journal Drugs and Aging
Print ISSN 1170-229X
Publisher Springer (part of Springer Nature)
Peer Reviewed Peer Reviewed
Volume 20
Issue 10
Pages 777-789
DOI https://doi.org/10.2165/00002512-200320100-00006
Keywords galantamine, donepezil, Alzheimer's
Public URL https://uwe-repository.worktribe.com/output/1068394
Publisher URL http://dx.doi.org/10.2165/00002512-200320100-00006




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