The original Pradaxa study the company used to gain FDA approval suggested a small increased risk of heart attack with the use of the drug compared to warfarin. Researchers since then have been trying to figure out whether there's really an increased risk. The study found the drug cut the risk of strokes by 35%.
According to an analysis by two Cleveland Clinic researchers published online in the Archives of Internal Medicine, Pradaxa boosted the risk of a heart attack and a condition known as acute coronary syndrome by 33%. The analysis involved more than 30,000 patients and compared those on Pradaxa to others in control groups, who received another blood-thinner like warfarin or enoxaparin, or a placebo.
The study's lead researcher Ken Uchino, a Cleveland Clinic neurologist, said the actual increase in the number of heart attacks and acute coronary syndrome events was very small and is outweighed by the benefit of the drug's ability to reduce the number of strokes. These events occurred in 1.19% of the Pradaxa patients, and in 0.79% of the control-group patients. Dr. Uchino and other researchers called for more study of the drug's potential to increase heart-attack risk.
Tuesday, January 10, 2012
Study Finds Risk In New Stroke Drug Pradaxa - WSJ.com