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Donepezil Benefits Alzheimer's Patients With Comorbidities

Donepezil appears to be effective and well tolerated in the treatment of mild-to-moderate Alzheimer's disease, according to the findings of an open-label multicentre trial.

In previous trial, donepezil was found to be effective and well tolerated, and it has been shown to provide significant benefits in cognition, global function and activities of daily living in patients with mild-to-moderate Alzheimer's disease. However, its efficacy in patients with comorbid illness and/or concomitant medication use is less clear.

Merce Boada-Rovira, MD, with Fundacio ACE, Barcelona, Spain, and colleagues conducted a 12-week trial of 1,113 patients with probable mild-to-moderate Alzheimer's disease enrolled at 246 study centres in 18 countries worldwide. About three fourths of the patients were taking at least one concomitant medication and two thirds had at least one comorbid medical condition on study entry. The patients' mean baseline MMSE score was 18.74.

Patients received donepezil 5 mg/day for 28 days, after which the dosage was increased to 10 mg/day depending upon the clinician's judgment. A trained clinician assessed cognition with the Mini-Mental State Examination (MMSE) at baseline, week 4 and week 12 (or last visit).

Changes in patient activity and social interaction were evaluated with a caregiver diary, in which caregivers recorded their impression of change in patient behaviour using a 5-point scale.

A total of 88.9% of patients completed the study and 5% of patients discontinued because of adverse events. Donepezil significantly improved cognition compared with baseline at weeks 4 and 12 (P < .0001). Mean change from baseline MMSE score was 1.73.

According to the researchers, donepezil was also associated with significant improvements in patient social interaction, engagement and interest, and initiation of pleasurable activities (all P < .0001). In addition, donepezil was generally well tolerated.

"The results of this open-label study received placebo in a previous 12-week, double- conducted in a large population of unselected patients are consistent with those of controlled trials and extend the knowledge of the risk benefit ratio of donepezil when used in a 'real-world' setting," Dr. Boada-Rovira and colleagues conclude.

Drugs Aging 2004;21:1:43-53. "Efficacy and safety of donepezil in patients with Alzheimer's disease : results of a global, multinational, clinical experience study"

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