Safety Concerns Halt Alzheimer's Drug Trials Reminyl

[Guest guest]

Safety Concerns Halt Alzheimer's Drug Trials Reminyl had shown promise

for treatment of mild cognitive impairment in patients with

Alzheimer's and other dementias. But clinical trial results showed

what was delicately termed " an imbalance of mortality. " That means

there were more deaths among patients taking the drug than among those

who weren't. Reminyl is currently approved in 69 countries worldwide

for treatment of mild to moderate Alzheimer's disease.

 

 

 

http://www.consumeraffairs.com/news04/2005/reminyl.html

 

Safety Concerns Halt Alzheimer's Drug Trials

 

 

January 25, 2005

 

 

Clinical trials have sounded alarm bells for another promising new

drug, this one to treat Alzheimer's patients. After consulting with

Food and Drug Administration regulators, Johnson & Johnson said the

safety of its drug Reminyl is now under review.

 

 

Reminyl is currently approved in 69 countries worldwide for treatment

of mild to moderate Alzheimer's disease. No regulatory applications

have been submitted for the potential use of the drug for the

treatment of mild cognitive impairment anywhere in the world, and the

company said none are planned.

 

Johnson & Johnson said the review was initiated as a result of a

preliminary safety assessment of an imbalance of mortality in two mild

cognitive impairment clinical trials submitted to health authorities

worldwide by Johnson & Johnson Pharmaceutical Research & Development,

L.L.C., in August 2004.

 

The clinical trial results also were presented last year at two

international scientific forums: the International Congress of

Alzheimer's Disease (ICAD) and the Alzheimer's Association Research

Roundtable Mild Cognitive Impairment Meeting.

 

Approximately 2,000 patients from 16 countries were enrolled in the

GAL-INT-11 and GAL-INT-18 studies, which were designed to evaluate a

potential decrease in the rate of progression from mild cognitive

impairment to dementia in subjects treated with the drug.

 

In the two-year trials, the company says 15 patients taking Reminyl

died, compared with five who were taking a placebo. Not all causes of

death were the same, but apparently enough were attributed to heart

attacks or strokes to cause concern and trigger a review.

 

It was a series of clinical trials that caused new concerns about the

safety of COX-2 inhibitors prescribed to treat arthritis. Merck

voluntarily withdrew Vioxx while Pfizer has suspended advertising for

Celebrex and Bextra. In those cases, clinical trials pointed to an

increase risk of heart attack or stroke for people taking the drugs.

 

Johnson & Johnson said mortality rates were low in both the Reminyl

and placebo groups in the two-year study compared to expected rates in

this population or in patients with Alzheimer's disease. The clinical

trials, it said, showed a higher relative mortality rate in patients

with mild cognitive impairment treated with Reminyl than in patients

treated with placebo.

 

The company said it is currently analyzing additional data from these

studies, including information retrieved from subjects who had dropped

out of the trials, and is discussing the results with regulatory

authorities.