Heart drug tests halted after patient deaths

Wednesday, December 13th 2000, 12:00 am

By: News On 6

PHILADELPHIA (AP) _ Pharmaceutical giant SmithKline Beecham has stopped testing a drug designed to prevent strokes and heart attacks after a surprising number of patients died while taking it.

The drug is the latest of a new, once promising, class of heart drugs called IIb/IIIa blockers to fail in final-stage testing.

The study was stopped after investigators learned that 2.7 percent of patients taking the drug, called lotrafiban, had died, compared with 2 percent in a comparison group.

Dr. Eric Topol of the Cleveland Clinic, who directed the study, said the difference was ``totally unexplained.''

Four percent of the patients getting the drug suffered major bleeding, compared with 1 percent in the comparison group.

The two-year study involved 9,197 patients at risk of heart attacks or strokes. Overall, 122 getting the drug plus aspirin died, compared with 92 of those getting aspirin plus dummy pills.

The company said the decision to end the tests was made after an independent board of medical experts reported safety concerns to SmithKline Beecham following a weekend review.

All patients involved in the tests were being notified to stop taking the drug.

``Getting this sort of recommendation, we felt the only responsible course was to close the trial,'' said Rick Koenig, a SmithKline Beecham spokesman.

Lotrafiban is intended to prevent blood clots that lead to heart attacks and strokes. The final-stage tests were being done to determine the drug's effectiveness and monitor any side effects.

Drugs similar to lotrafiban that have already been discontinued from development include Searle's orbofiban and xemilofiban and Roche's sibrafiban.

Still in testing are roxifiban and cromafiban. Delaware-based DuPont and COR Therapeutics in San Francisco, developers of those two drugs, did not immediately return telephone calls Tuesday.

SmithKline Beecham, with U.S. headquarters in Philadelphia, markets more than 400 products, including the anti-depressant Paxil and the smoking cessation patch and gum known as Nicorette.