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

ABSTRACT:

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

SUBMITTER: Farlow M 

PROVIDER: S-EPMC3126705 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature