122 deaths ``totally unexplained,''
Heart Drug Trials Halted
By TINA MOORE
Associated Press Writer
PHILADELPHIA (AP) -- Pharmaceutical giant SmithKline Beecham has halted clinical tests of a drug designed to fight strokes and heart attacks after a surprising number of patients died while taking it.
The 122 deaths are ``totally unexplained,'' said Dr. Eric Topol of the Cleveland Clinic, who led an independent investigation into Lotrafiban and reported safety concerns to SmithKline Beecham after a weekend review.
All 9,197 patients involved in the Phase III study of Lotrafiban were being notified to stop taking the drug.
``Getting this sort of recommendation, we felt the only responsible course was to close the trial,'' Rick Koenig, a SmithKline Beecham spokesman, said Tuesday.
Lotrafiban is part of a drug class intended to prevent blood clots that lead to heart attacks and strokes.
The patients were taking a combination of Lotrafiban and aspirin, Topol said. By comparison, only 92 people who were taking a placebo died in the double-blind study that has been ongoing for nearly two years.
The 122 patients, all of whom had heart or neurological conditions, did not die of heart attacks or strokes, Topol said. Bleeding was a problem during the tests, but was treatable with transfusions.
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