- Long-term use of Brilinta (ticagrelor) is effective in patients with heart and stroke risks, but associated with increased risk of bleeding, according to a new study published in the New England Journal of Medicine.
- In clinical studies, Brilinta decreased the risk of heart attack and stroke by 16%.
- "There will be more bleeding, but I think the benefit for patients in terms of reducing their risk of dying or having another heart attack or stroke outweighs that," said Marc Sabatine, a trial researcher from Brigham and Women's Hospital.
The data clearly suggest a link between increased risk of bleeding and use of Brilinta; however, there are differences in terms of risk, depending on which dosage of Brilinta is used. Based on clinical study data, in 10,000 patients taking Brilinta, a total of 42 heart attacks could be prevented in at-risk patients; however, 31 patients would be affected by a major bleeding episode.
Standard secondary prevention of heart attack and stroke in at-risk patients has been aspirin, however, adding Brilinta to aspirin provides significant risk-reduction benefits. With respect to dosing, a 60 mg dose of Brilinta (plus aspirin) decreased risk of heart/attack stroke from 9.04% to 7.77%. But when the Brilinta dose was increased to 90 mg, bleeding risk increased more than two-fold, from 1.06% to 2.3%.
Clearly, dosing must be considered as a major safety issue when treating patients with Brilinta. Nonetheless, this study suggests that the drug may be considered clinically beneficial for many patients, including patients who might traditionally have been treated with aspirin alone or clopidogrel.