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The manufacturer of the new heart drug lotrafiban, SmithKline Beecham,
has just halted clinical tests after a surprising number of patients
died while taking it.
The drug is the latest of a new, once promising, class of anti-clotting
heart drugs called IIb/IIIa blockers to fail in final-stage testing.
The drugs work by blocking receptors for the glycoprotein fibrinogen,
which is critical for proper blood clotting.
The study was stopped after investigators learned that 2.7 percent
of patients taking the drug had died, compared with 2 percent in
a comparison group.
The 122 deaths are "totally unexplained," said Eric Topol
of the Cleveland Clinic, who directed the study and reported safety
concerns to SmithKline Beecham after a weekend review.
In addition, 4 percent of the patients getting the drug suffered
major bleeding, compared with 1 percent in the comparison group.
Bleeding was a problem during the tests, but was treatable with
transfusions, Dr. Topol notes.
Currently 9,197 patients are enrolled in the Phase III study, where
they were taking a combination of lotrafiban and aspirin.
Dr. Topol was involved in two previous studies of oral anti-clotting
agents. When data from those trials was released in August 1999,
Topol said, he recommended halting the lotrafiban study. But by
then, he said, the tests were "well under way."
Trials of other drugs in the same class - roxifiban and cromafiban,
made by DuPont and COR Therapeutics are ongoing.
The Washington Post/Associated
Press, December 13, 2000
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