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Patients With Vascular Dementia Tolerate Donepezil With Few Cardiovascular Complications: Presented at ISC

By Cameron Johnston
Special to DG News

PHOENIX, AZ -- February 18, 2003 -- Patients with presumed vascular dementia tolerated donepezil with few adverse events and few cardiovascular complications, according to trial results.

Dr. Sandra Black, principal investigator of the study, presented the results here at the 28^th International Stroke Conference on Saturday, February 15^th. She pointed out that it is believed that some patients with vascular dementia also exhibit a cholinergic deficit and could potentially benefit from the use of acetylcholinesterase inhibitors (donepezil). Dr. Black is a professor of medicine in neurology at the University of Toronto and chair of the department of neurology at Sunnybrook and Women's College Health Sciences Centre, in Toronto, Canada.

The study was a sub-analysis of two separate randomly controlled trials, and included 893 subjects who were assigned to three groups. The patients were assigned to take, over a period of 24 weeks, either placebo, donepezil 5 mg, or donepezil 10 mg.

The subjects all met the NINDS-AIRENS definition of vascular dementia.

They had well-established vascular disease, as well as other risk factors that could complicate vascular function, Dr. Black said. Eighty two percent had a history of prior stroke, 20% were diabetic, 40% had lipid abnormalities, and 99% had abnormal computed tomography or magnetic resonance imaging scans.

Mental status and functional abilities were recorded on the ADAS-Cog, CIBIC-Plus and the CRDS instruments.

Both donepezil groups fared better than the placebo group on the CIBIC-Plus at week 24. Patients in the placebo group showed only a 32% change from baseline, those in the 5 mg/day group showing a 46% change, and those in the 10 mg/day group a 36% change from baseline.

On the Clinical Dementia Rating Scale, the difference in change over baseline was statistically significant in the 10 mg/day group, but not in the 5 mg/day group.

On the ADAS-Cog, those receiving 10 mg/day did significantly better than placebo from week-four through to the end of the 24-week study

As for safety aspects of the trial, leg cramps and nausea were the most commonly reported adverse events. Syncope was more common in patients receiving donepezil 10 mg/day, but still this occurred in fewer than 10% of the subjects. There was no difference in the rate of bradycardia or total cardiovascular events - in fact, more patients in the placebo group developed a transient ischaemic attack (TIA) or had problems with hypertension, it was reported.

"This study shows that donepezil patients, overall, had a significant improvement in cognitive function, as seen on the ADAS-Cog, and in global function as seen on the CIBIC and the CDR," Dr. Black commented.

"These results demonstrate that despite the high level of cerebro- and cardiovascular risk factors, and the many concomitant medications taken by these VaD patients, donepezil was well-tolerated and appears to be safe in this population," she added.

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