A cohort study of effectiveness of acetylcholinesterase inhibitors in Alzheimer's disease.
OBJECTIVE
To characterise the population of Alzheimer's disease patients treated with acetylcholinesterase inhibitors, to analyse effectiveness and drug safety in the clinical practice, and to identify variables that may predict the response to therapy.


METHODS
From September 2000 to December 2001, a total of 5,462 patients diagnosed with mild to moderate Alzheimer's disease were enrolled at the time of their first prescription of the study drugs and followed up for an average of 10.5 months. Responders were defined as patients with a mini-mental state examination (MMSE) score improvement of 2 or more points from baseline after 9 months of therapy.


RESULTS
At 9 months, 2,853 patients (52.2%) completed the study. The mean change from baseline in MMSE scores was an improvement of 0.5 points (+/-3.0). The proportion of responders to the therapy was 15.7% at 9 months. A greater probability of response at 9 months was observed among patients without concomitant diseases at baseline [odds ratio (OR)=2.1, 95% confidence interval (CI) 1.5-2.9] and among those with a response at 3 months (OR=20.6, 95% CI 17.2-24.6). During the study period, 285 patients (5.2%) discontinued the treatment because of an adverse drug reaction.


CONCLUSIONS
Effectiveness of acetylcholinesterase inhibitors on cognitive symptoms of patients with mild to moderate Alzheimer's disease is modest. At 9 months, improvement was evident only in a subgroup of patients without concomitant diseases and who had demonstrated a response at 3 months.
Raschetti
Roberto
R
National Center for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.
Maggini
Marina
M
Sorrentino
Giacoma Carla
GC
Martini
Nello
N
Caffari
Bruno
B
Vanacore
Nicola
N
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D003072:Cognition Disorders / Q000188:drug therapy*; D015331:Cohort Studies; D000077265:Donepezil; D005260:Female; D005500:Follow-Up Studies; D005702:Galantamine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D008875:Middle Aged; D048448:Phenylcarbamates / Q000008:administration & dosage / Q000627:therapeutic use*; D010880:Piperidines / Q000008:administration & dosage / Q000627:therapeutic use*; D000068836:Rivastigmine; D013997:Time Factors; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D007189:Indans; D048448:Phenylcarbamates; D010880:Piperidines; D005702:Galantamine; D000077265:Donepezil; D000068836:Rivastigmine