Objective: Donepezil, a selective reversible acetylcholinesterase inhibitor, is approved for the symptomatic treatment of mild to moderately severe Alzheimer’s disease (AD) in over 50 countries. Due to the progressive nature of the disease as well as the high rate of co-morbidity, treatment data from different patient groups should be evaluated to obtain greater insight into the expected response. The treatment response in 3 subgroups was compared after 2 different observation periods: 3 months versus 6 months following initiation of donepezil therapy.
Design: 2029 Alzheimer patients were enrolled in a multicentre, post-marketing surveillance (PMS) study in Germany.
Materials and Methods: 421 patients with concomitant cerebrovascular disease (CVD+), 122 patients with additional parkinsonian symptoms (PS+) and 1188 patients without either of these co-factors (CVD-/PS-) were evaluated in the efficacy analysis. The influence of donepezil on dementia symptoms was categorized using the 7-item Clinical Global Impression scale (CGI). Safety data were also evaluated.
Results: 71.9% of CVD-/PS- patients showed a global improvement after 3 months of donepezil therapy, and 76.7% showed an improvement after 6 months. In the CVD+ group, 69.3% of patients were judged “improved” after 3 months, and 74.9% after 6 months. 70.5% of PS+ patients were judged “improved” after 3 months and 78.2% after 6 months. Interestingly, more patients showed an improvement categorized as “markedly to very much improved” between 3 and 6 months than from baseline to 3 months, especially in the PS+ group. Donepezil was very well tolerated. AEs were reported in only 236 of 2029 patients (11.6%). Extrapyramidal symptoms in the PS+ patients were not exacerbated by donepezil therapy.
Conclusion: Approximately 3 out of 4 patients showed a global improvement after receiving donepezil therapy, irrespective of cerebrovascular and parkinsonian co-factors. In addition to the main treatment effect observed after 3 months, a trend towards further improvement was observed between 3 and 6 months, suggesting an increase of therapeutic effect within the individual patient during this time. Based on these data, an observation period of at least 6 months of donepezil therapy is recommended before judging treatment response.
Back to PB Tuesday Poster Sessions
Back to The Eleventh International Congress