Increased mortality in Aricept VaD trial cohort

Japanese firm Eisai says that preliminary results from trials of its drug Aricept (donepezil), in the treatment of vascular dementia, show that there was a statistically-significant increase in mortality in those patients taking the drug versus placebo. In total, 11 deaths were reported in the 648 study subjects who received the drug, in comparison with no reported mortality in the 319-patient strong placebo cohort.

The study was a Phase III randomized, multicenter, double-blind assessment of the compound's safety and efficacy in the treatment of patients with VaD in the absence of prior AD diagnosis. Subjects were given 5mg of the drug, or placebo, once-daily for 24 weeks.

Aricept is approved for the treatment of mild-to-moderate Alzheimer's disease, but not VaD, in the USA, Japan and the European Union. The drug is also approved for AD in Indian, New Zealand, the Philippines, Romania, South Korea and Thailand, in addition to the treatment of VaD. The company said it had reported the safety findings to regulatory authorities worldwide, but that the results had not effected the product's favorable risk-benefit profile.