Safety and Tolerability of Donepezil 23 mg in Alzheimer's Disease
Author Information
Author(s): Martin Farlow, Felix Veloso, Margaret Moline, Jane Yardley, Elimor Brand-Schieber, Francesco Bibbiani, Heng Zou, Timothy Hsu, Andrew Satlin
Primary Institution: Indiana University School of Medicine
Hypothesis
Does increasing the dose of donepezil from 10 mg/d to 23 mg/d improve safety and tolerability in patients with moderate to severe Alzheimer's disease?
Conclusion
The 23 mg/d dose of donepezil has a good safety and tolerability profile, supporting its use in patients with moderate to severe Alzheimer's disease.
Supporting Evidence
- The study included 1434 patients who took at least one dose of the study drug.
- Patients taking donepezil 23 mg/d experienced a higher rate of gastrointestinal adverse events compared to those on 10 mg/d.
- Serious adverse events were uncommon in both treatment groups.
- Completion rates were 71.1% for the 23 mg/d group and 84.7% for the 10 mg/d group.
Takeaway
This study looked at how safe and tolerable a higher dose of donepezil is for people with Alzheimer's. It found that the higher dose is generally safe and well-tolerated.
Methodology
The study was a randomized, double-blind, parallel-group trial comparing donepezil 23 mg/d to 10 mg/d over 24 weeks.
Limitations
The study had limited representation of Hispanic and black populations and a duration of only 24 weeks.
Participant Demographics
{"age_mean":73.9,"gender_distribution":{"male":37.0,"female":63.0},"race_distribution":{"white":73.5,"asian_pacific":16.7,"hispanic":7.0,"black":2.3,"other":0.5}}
Digital Object Identifier (DOI)
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