Eisai: Aricept study for vascular dementia results in more deaths from drug than placebo

By E. Janene Geiss

Philadelphia, March 16 - Eisai Co., Ltd. announced Thursday preliminary results from the latest Aricept (donepezil) study on the treatment of people with vascular dementia showing that those who received donepezil improved on measures of cognition, but not global function (overall clinical effect), compared with those who received a placebo.

While there was no statistically significant difference in the overall occurrence of adverse events, there were more deaths observed in the donepezil group than in the placebo group, according to a company news release.

Consistent with Eisai's standard practice, these safety results were reported to regulatory authorities and investigators currently participating in donepezil clinical trials, officials said.

In the United States, Japan and in the European Union, donepezil is approved only for the treatment of mild to moderate Alzheimer's disease and not for vascular dementia. But it is approved for vascular dementia in India, New Zealand, Philippines, Romania, South Korea and Thailand, officials said.

The trial was a multi-center, randomized, double-blind study conducted in nine countries. The study was designed to enroll only people with vascular dementia and with no prior diagnosis of Alzheimer's disease.

Patients were randomized to 5 mg of donepezil or a placebo in a 2 to 1 ratio.

The drug was administered once daily for 24 weeks. As in two previous vascular dementia studies, the majority of participants in this trial had a history of stroke and/or heart disease and most were taking other medications, most frequently to treat cardiovascular risk factors.

Participants treated with donepezil showed statistically significant improvement on the primary measure of cognitive function as compared to those who received a placebo, officials said.

No statistically significant benefit was observed on the other primary measure, the CIBIC-plus, which evaluates global function. Some of the secondary measures for cognitive function showed statistically significant benefit, while others did not, officials said.

These results were generally consistent with the two previously published studies of donepezil in vascular dementia, officials said.

A review of the safety data for this most recent study found a difference in the percent of study participants who died in the donepezil group and the placebo group. There were 11 deaths reported in the donepezil group of 648 study participants and none in the group of 326 people given a placebo, officials said.

Eisai said it will continue to engage in discussions with regulatory authorities regarding the donepezil vascular dementia program.

Eisai said it has reported to regulatory authorities worldwide that it is the company's position that the results of this study do not change the overall safety profile of donepezil and that its benefit-risk profile continues to be favorable for its approved indications.

Based in Tokyo, Eisai is research-based human health care company that discovers, develops and markets products in more than 30 countries.

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