Merck & Co. said its decision last week to halt one study on the anticlotting pill vorapaxar and narrow the scope of another was prompted by bleeding risks to patients with a history of strokes.
The drug was linked by a board of safety experts to an increased risk of intracranial hemorrhage in patients who had previously suffered strokes, Whitehouse Station, New Jersey- based Merck said today in a statement.
Researchers said Jan. 13 that they would stop a study of 13,000 patients who began taking vorapaxar at the onset of a heart attack or chest pain. A second study, of 26,500 patients who previously had heart disease, was stopped for the 25 percent with a history of stroke.
The safety board recommended completing the trial for the more than 20,000 patients who hadn’t previously suffered strokes, said Dr. Eugene Braunwald, chairman of the larger study, in the statement.
“On the basis of their recommendation, we and Merck remain committed to completing this important scientific investigation with a potential for a reduction in death and ischemic events in these patients,” Braunwald said.
Thursday, January 20, 2011
Merck's Blood-Thinner Posed Bleeding Risks to Patients with Stroke History - Bloomberg
via bloomberg.com
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