While clinical trial results for AstraZeneca’s heart drug Brilinta (ticagrelor) are positive, the trail showed bleeding risks with the blood-thinning drug.
A 21,000-patient clinical trial showed Brilinta (ticagrelor) cuts heart attacks and strokes, but caused more bleeding, Reuters reports.
Results of the PEGASUS trial were presented recently at the American College of Cardiology annual meeting. An editorial in the New England Journal of Medicine accompanying publication of the trial results was cautious about long-term use of Brilinta. The editorial said that for each 10,000 patients taking Brilinta, the drug would prevent 42 cardiovascular events annually but cause 31 major bleeds. The current standard care for patients more than one year on from a heart attack is aspirin alone to prevent clotting, but AstraZeneca wanted to prove its case for adding Brilinta for long-term treatment, according to Reuters.
The efficacy end point was virtually the same with low-dose ticagrelor (60 mg twice daily) or high-dose ticagrelor (90 mg twice daily), according to Medscape. But patients had a 2.3-fold and 2.6-fold higher risk of clinically significant bleeding and a 3.0-fold and 3.7-fold higher risk of transfusion with low-dose and high-dose ticagrelor, respectively, compared with patients in the trial on a placebo. The drug was also associated with about a threefold greater risk of dyspnea (shortness of breath). Roughly 30 percent of patients discontinued the study drug.
The New England Journal of Medicine editorial said the data would “prompt speculation as to whether dual platelet inhibition with high-potency agents is approaching the point of diminishing returns.” Doctors may be selective about prescribing Brilinta, Reuters said, perhaps prescribing the older drug Plavix (clopidogrel), which is now available as a cheap generic.