Deaths reported in dementia trial
pharmafile | March 16, 2006 | News story | Research and Development |Â Â Â
Eleven patients have died in a study investigating Eisai/Pfizer's Aricept in the treatment of vascular dementia – but investigators say the results are no cause for alarm.
Aricept (donepezil) is well established as a treatment for mild to moderate Alzheimer's disease in Europe and the US, but is also licensed to treat vascular dementia in India, New Zealand, the Philippines, Romania, South Korea and Thailand.
Early results from the trial show patients taking donepezil saw cognition improve, but not 'global function' or overall clinical effect compared with those who received placebo, suggesting the benefits are limited in these patients.
Levels of adverse effects were similar between the donepezil group and the placebo group, but eleven men taking the drug died, compared to none in the other group.
Following analysis of the data, the investigators concluded that no deaths in the placebo group is an unexpectedly low mortality rate, and is 'an unusual finding in this population, considering the age and pathology' of patients in the study.
Most patients on the trial had a history of stroke and/or heart disease, and the majority were taking other medications, most frequently to treat cardiovascular risk factors.
Eisai says it will communicate with regulators about trials of the drug in vascular dementia, but has told the authorities it believes the latest results have not changed its overall safety profile.






