Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimer’s disease
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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.
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Cholinesterase inhibitors can contribute to nausea, vomiting, diarrhea, and weight loss, and several studies have documented increased GI adverse events with these agents.
“Cholinesterase inhibitors can contribute to nausea, vomiting, diarrhea, and weight loss, and several studies have specifically documented increased GI adverse events with these agents (Darreh-Shori et al., 2010; Farlow et al., 2011).”
From Autonomic nervous system and gastrointestinal manifestations with an emphasis on gastric dysfunction (2026) · cites this paper as Farlow et al., 2011
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- Authors
- Farlow, M., Veloso, F., Moline, M., Yardley, J., Brand-Schieber, E., Bibbiani, F., Zou, H., Hsu, T., & Satlin, A.
- Affiliations
- Indiana University School of Medicine (US)
- Eisai (United States) (US)
- Eisai (United Kingdom) (GB)
- Corresponding author
- Farlow, Martin
- Venue
- BMC Neurology
- Published
- 2011-05-25
- Volume
- 11
- Issue
- 1
- Pages
- 57-57
- ISSN
- 1471-2377 (ISSN-L)
- PMC
- PMC3126705
- OpenAlex
- W2033774309
- Cited by
- 95
- References
- 13
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 5 · 2023: 4 · 2022: 5 · 2021: 8 · 2020: 2 · 2019: 4 · 2018: 14 · 2017: 4 · 2016: 8 · 2015: 8 · 2014: 6 · 2013: 10 · 2012: 7
- FWCI
- 5.86
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Neurology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Pfizer
- Eisai
- Topics
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Keywords
- Alzheimer's disease, dose titration, safety, tolerability, adverse events, nausea, vomiting, diarrhea, dizziness, cholinesterase inhibitors, treatment-emergent adverse events, serious adverse events, electrocardiographic changes, vital signs, laboratory parameters, weight change
- MeSH terms
- Donepezil, Age Factors, Aged, Aged, 80 and over, Alzheimer Disease, Body Weight, Cholinesterase Inhibitors, Dose-Response Relationship, Drug, Emergency Services, Psychiatric, Female, Humans, Indans, Male, Piperidines, Severity of Illness Index, Sex Factors, Treatment Outcome
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