The Effectiveness and Tolerability of the High Dose Donepezil at 23 mg Tablet per Day for Alzheimer’s Disease: A Meta-analysis of Randomized Controlled Trials

Abstract

Objective. To assess the effectiveness and tolerability of the 23 mg tablet donepezil in patients with Alzheimer’s disease (AD) using meta-analysis of randomized controlled trials.

Methods. Major healthcare databases were searched from May to September 2016. Evaluation of relevant trials, assessment of risk of bias, collection and analyses of data were performed.

Results. A total of 1,774 adult participants with AD were pooled from the two trials included. Pooled data showed that after 24 weeks of treatment, no significant difference was noted between Donepezil 23 mg/day and Donepezil 10 mg/day in terms of cognitive function (1.06 SIB points [-0.13, 2.26]; 1704 participants) and in terms of global clinical assessment (-0.02 CIBIC+ points [-0.13, 0.09]; 1705 participants). The participants who took the higher dose were at higher risk to experience “any adverse event” than those who received the lower dose (1.17 RR [1.09, 1.26]; 1785 participants).

Conclusion. Current evidences do not support the routine use of Donepezil 23 mg tablet for the improvement of cognitive function and global clinical status of patients with AD. The higher dose is also marked with an increased incidence of adverse events compared to the lower dose.