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


METHODS
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.


METHODS
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 < or = 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 < or = 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.
Wilcock
Gordon
G
Department of Care of the Elderly, University of Bristol, Frenchay Hospital, Bristol, UK.
Howe
Ian
I
Coles
Hilary
H
Lilienfeld
Sean
S
Truyen
Luc
L
Zhu
Young
Y
Bullock
Roger
R
Kershaw
Paul
P
D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D003071:Cognition / Q000187:drug effects; D000077265:Donepezil; D004334:Drug Administration Schedule; D005260:Female; D005702:Galantamine / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D007189:Indans / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008609:Mental Status Schedule; D010880:Piperidines / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013995:Time; D016896:Treatment Outcome
D007189:Indans; D010880:Piperidines; D005702:Galantamine; D000077265:Donepezil