[Observational study on safety, tolerability and effectiveness of galantamine in patients with mild to moderately severe Alzheimer's disease].
BACKGROUND
Several controlled clinical trials have demonstrated safety, tolerability, and efficacy of galantamine in patients with Alzheimer's disease (AD). We present an observational and multicenter study carried out in Spain. Its main objective was the assessment of the safety and tolerability of galantamine in the treatment of mild to moderately severe dementia of the Alzheimer type under real clinical conditions.


METHODS
The study had five visits over a 6-month period. Titration of galantamine was performed on a standard basis. All the adverse events (AE) reported were recorded. Serious AE were particularly considered. Effectiveness was also assessed covering cognitive, functional, behavioral and sleep domains.


RESULTS
723 patients were enrolled but 74 were excluded, a sample of 649 (71% women and 29% men) remaining. A total of 56.3% patients completed all visits. Baseline Mini-Mental mean score was 19,4 (SD: 4,7). Up to 400 AEs were collected from 29.3% of the patients. The commonest AEs were: nausea (9.7%), vomiting (7.1%), dizziness (4.6%), and diarrhea (4.5%). Mini-Mental scores were stable over time and favorable and significant differences in behavioral and sleep evaluations were observed.


CONCLUSIONS
Galantamine is a safe and well-tolerated treatment, and provides cognitive, functional, and behavioral benefits in patients with mild to moderately severe AD.
Blesa
R
R
Hospital de la Santa Creu i Sant Pau, Barcelona, and Hospital Clinicao Universitario San Carlos, Madrid, Spain. rblesa@hsp.santpau.es
García Ribas
G
G
Galdós
L
L
Olascoaga
J
J
Amer
G
G
Marey López
J
J
Barquero
M
M
Marsall
C
C
Ezpeleta
D
D
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000503:physiopathology; D001526:Behavioral Symptoms; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D005260:Female; D005702:Galantamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged
D002800:Cholinesterase Inhibitors; D005702:Galantamine