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Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimer’s disease


Farlow, Martin, Veloso, Felix, Moline, Margaret, Yardley, Jane, Brand-Schieber, Elimor, Bibbiani, Francesco, Zou, Heng, Hsu, Timothy, Satlin, Andrew


BMC Neurology, Volume: 11, Pages.: 57-57

Year of Publication



Background: Donepezil 23 mg/d, recently approved in the United States for treatment of moderate to severe Alzheimer’s disease (AD), was developed to address the need for an additional treatment option for patients with advanced AD. This report, based on a pivotal phase 3 study, presents a detailed analysis of the safety and tolerability of increasing donepezil to 23 mg/d compared with continuing 10 mg/d.; Method: Safety analyses comprised examination of the incidence, severity, and timing of treatment-emergent adverse events (AEs) and their relationship to treatment initiation; changes in weight, electrocardiogram, vital signs, and laboratory parameters; and the incidence of premature study discontinuation. The analysis population (n = 1434) included all randomized patients who took at least 1 dose of study drug and had a postbaseline safety assessment. To further examine the effect of transition from a lower to a higher donepezil dose, a pooled analysis of safety data from 2 phase 3 trials of donepezil 5 mg/d and 10 mg/d was also performed.; Results: The safety population comprised 1434 patients: donepezil 23 mg/d (n = 963); donepezil 10 mg/d (n = 471); completion rates were 71.1% and 84.7%, respectively. The most common AEs were nausea, vomiting, and diarrhea (donepezil 23 mg/d: 11.8%, 9.2%, 8.3%; donepezil 10 mg/d: 3.4%, 2.5%, 5.3%, respectively). AEs that contributed most to early discontinuations were vomiting (2.9% of patients in the 23 mg/d group and 0.4% in the 10 mg/d group), nausea (1.9% and 0.4%), diarrhea (1.7% and 0.4%), and dizziness (1.1% and 0.0%). The percentages of patients with AEs in the 23 mg/d group, as well as the timing, type, and severity of these AEs, were similar to those seen in previous donepezil trials with titration from 5 to 10 mg/d. Serious AEs were uncommon (23 mg/d, 8.3%; 10 mg/d, 9.6%).; Discussion: The 23 mg/d dose of donepezil was associated with typical cholinergic AEs, particularly gastrointestinal-related AEs, similar to those observed in studies with a dose increase from 5 to 10 mg/d.; Conclusion: The good safety and predictable tolerability profile for donepezil 23 mg/d supports its favorable risk/benefit ratio in patients with moderate to severe AD.;

Bibtex Citation

@article{Farlow_2011, doi = {10.1186/1471-2377-11-57}, url = {}, year = 2011, month = {may}, publisher = {Springer Nature}, volume = {11}, number = {1}, author = {Martin Farlow and Felix Veloso and Margaret Moline and Jane Yardley and Elimor Brand-Schieber and Francesco Bibbiani and Heng Zou and Timothy Hsu and Andrew Satlin}, title = {Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimer{textquotesingle}s disease}, journal = {{BMC} Neurology} }


administration & dosage, adverse effects, age factors, aged, aged, 80 and over, alzheimer disease, body weight, cholinesterase inhibitors, donezepil, drug therapy, emergency services psychiatric, female, humans, indans, male, medications, pharmacokinetics, piperidines, severity of illness index, sex factors, tolerability, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Other, Physical Health

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

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