Clinical trial results for AstraZeneca’s heart drug Brilinta (ticagrelor) showed the drug helped reduce heart attacks and strokes but showed an increase in bleeding.
The results of a 21,000-patient clinical trial presented at the American College of Cardiology annual meeting showed Brilinta (ticagrelor) cuts heart attacks but caused more bleeding, Reuters reports.
The trial results were published online in the New England Journal of Medicine. An editorial accompanying publication was cautious about long-term use of Brilinta. The editorial said that for every group of 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 make a case for adding Brilinta to aspirin for long-term treatment of patients who had had a heart attack, according to Reuters.
Trial results showed efficacy was virtually the same with either 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 both dose levels, 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 in the trial discontinued the study drug.
According to the New England Journal of Medicine editorial, the trial data would “prompt speculation as to whether dual platelet inhibition with high-potency agents is approaching the point of diminishing returns.” Reuters noted that doctors may be selective in prescribing Brilinta, perhaps choosing the older drug Plavix (clopidogrel), which is now available in generic form.