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Long-term safety and tolerability of donepezil 23 mg in patients with moderate to severe Alzheimer’s disease


Tariot, Pierre, Salloway, Steven, Yardley, Jane, Mackell, Joan, Moline, Margaret


BMC Research Notes, Volume: 5, Pages.: 283-283

Year of Publication



Background: Donepezil (23 mg/day) is approved by the US Food and Drug Administration for the treatment of patients with moderate to severe Alzheimer’s disease (AD). Approval was based on results from a 24-week, randomized, double-blind study of patients who were stable on donepezil 10 mg/day and randomized 2:1 to either increase their donepezil dose to 23 mg/day or continue taking 10 mg/day. The objective of this study was to assess the long-term safety and tolerability of donepezil 23 mg/day in patients with moderate to severe AD.; Methods: Patients who completed the double-blind study and were eligible could enroll into a 12-month extension study of open-label donepezil 23 mg/day. Clinic visits took place at open-label baseline and at months 3, 6, 9, and 12. Safety analyses comprised examination of the incidence, severity, and timing of treatment-emergent adverse events (AEs); changes in weight, electrocardiogram, vital signs, and laboratory parameters; and discontinuation due to AEs.; Results: 915 double-blind study completers were enrolled in the open-label extension study and 902 comprised the safety population. Mean treatment duration in this study was 10.3 ± 3.5 months. In total, 674 patients (74.7%) reported at least one AE; in 320 of these patients (47.5%) at least one AE was considered to be possibly or probably study drug related. The majority of patients reporting AEs (81.9%) had AEs of mild or moderate severity. There were 268 patients (29.7%) who discontinued early, of which 123 (13.6%) were due to AEs.Patients increasing donepezil dose from 10 mg/day in the double-blind study to 23 mg/day in the extension study had slightly higher rates of AEs and SAEs than patients who were already receiving 23 mg (78.0% and 16.9% vs 72.8% and 14.0%, respectively). The incidence of new AEs declined rapidly after the first 2 weeks and remained low throughout the duration of the study.; Conclusion: This study shows that long-term treatment with donepezil 23 mg/day is associated with no new safety signals. The elevated incidence of AEs in patients increasing the dose of donepezil from 10 mg/day to 23 mg/day was limited to the initial weeks of the study.;

Bibtex Citation

@article{Tariot_2012, doi = {10.1186/1756-0500-5-283}, url = {}, year = 2012, publisher = {Springer Nature}, volume = {5}, number = {1}, pages = {283}, author = {Pierre Tariot and Steven Salloway and Jane Yardley and Joan Mackell and Margaret Moline}, title = {Long-term safety and tolerability of donepezil 23{hspace{0.167em}}mg in patients with moderate to severe Alzheimer's disease}, journal = {{BMC} Research Notes} }


administration & dosage, adverse, adverse effects, aged, aged, 80 and over, alzheimer disease, ambulatory care, biomarkers pharmacological, cognition, donepezil, doseresponse relationship drug, drug administration schedule, drug effects, drug therapy, evenrs, female, followup studies, humans, indans, male, metabolism, middle aged, neuropsychological tests, nootropic agents, physiopathology, piperidines, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime