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11 Aricept Deaths in Clinical Trial
Excess Deaths in Vascular Dementia Patients Taking Alzheimer's Drug
By Daniel J. DeNoon
WebMD Health NewsReviewed by Louise Chang, MDMarch 17, 2006 - There were 11 deaths in vascular dementia patients taking the Alzheimer's drug Aricept in a clinical study -- and no deaths in patients taking inactive placebo pills.

The report comes from Aricept maker Eisai Co. Ltd., Tokyo, which sells Aricept in partnership with U.S.-based Pfizer. In the U.S., Aricept is approved for the treatment of mild-to-moderate Alzheimer's disease.

In the trial, there were 11 deaths among 648 vascular dementia patients taking Aricept and zero deaths among 326 patients given placebo in the 24-week study. That's a striking difference. But it may very well be due to a surprisingly low death rate in the placebo group -- and not to any previously unknown risk from Aricept.

No Need for Warning
The FDA is looking at the data but currently finds no reason to issue a warning, says FDA spokeswoman Susan Cruzan.

"FDA is examining the results of the study. We have done a quick review of it and at this point we don't have a major cause of concern," Cruzan tells WebMD. "The drug remains a safe option for patients who are receiving it."

Eisai spokeswoman Judee Shuler notes that the study is the third clinical trial of Aricept in vascular dementia patients. When all three studies are considered together, the death rate among those taking Aricept was 1.7% vs. a 1.1% death rate in placebo recipients. That difference is not statistically significant, meaning it's likely due to chance.

"It is Eisai's position that the results of this study do not change the overall safety profile of Aricept," Shuler tells WebMD. "The safety profile of Aricept continues to be favorable for its approved indication [for mild-to-moderate Alzheimer's disease]."

What Doctors Say
WebMD asked two leading dementia experts what they thought about the Aricept news:

Sid Gilman, MD, director of the Michigan Alzheimer's Disease Research Center and distinguished professor of neurology at the University of Michigan, Ann Arbor.
Howard S. Kirshner, MD, professor and vice chairman of neurology at Vanderbilt University in Nashville, Tenn.

http://www.webmd.com/alzheimers/news...clinical-trial


cardiac death classification in clinical trials. Of. 109 deaths in an ICD trial. 24 were initially. classified as sudden cardiac (presumably due to ...
http://www3.interscience.wiley.com/j...97395/abstract

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Annals of Oncology 1:175-181, 1990
© 1990 European Society for Medical Oncology

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research-article


Responses and toxic deaths in Phase I clinical trials*
G. Decoster1,, G. Stein2 and E. E. Holdener1
1Department of Clinical Research, Division of Oncology, F. Hoffmann-LaRoche Ltd CH-4002 Basle, Switzerland
2Statistics for Research, SFR Ltd CH-4051 Basle, Switzerland

Correspondence to: Genevieve Decoster, M.D. Department of Clinical Research-Oncology F. Hoffmann-LaRoche Ltd Grenzacherstrasse 124 CH-4002 Basle, Switzerland


This review analysis consists of the antitumor activity and toxic deaths reported in single agent Phase I clinical trials using cytotoxic compounds published from 1972 to 1987. A total of 6639 patients with a variety of solid tumors and hematological malignancies were accrued in 211 trials studying 87 compounds. The median number of patients per trial was 28 (range: 7–111) and the median of the median ages reported in the individual trial was 56 (range of individual age: 2 to 93 years). Ten percent of the trials enrolled pediatric patients (< 18 years), but the exact numbers of children were not always given or separated from the adult patients.

http://annonc.oxfordjournals.org/cgi...stract/1/3/175

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an entire page of facts about childrens death in clinical trials

http://tinyurl.com/5n375b