The Food and Drug Administration has approved Brilinta (ticagrelor; AstraZeneca) to reduce the risk of a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease (CAD).

The approval was based on data from the multinational, double-blind, placebo-controlled phase 3 THEMIS trial that compared the effects of ticagrelor plus aspirin to placebo plus aspirin in 19,220 patients aged ≥50 years with CAD and type 2 diabetes (T2D) and no prior history of MI or stroke. The primary end point was the composite of first occurrence of cardiovascular (CV) death, MI, or stroke. The primary safety outcome was major bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria.

Results showed that ticagrelor was superior to placebo in reducing the incidence of CV death, MI, or stroke at a median follow-up of 39.9 months (7.7% vs 8.5%, respectively; hazard ratio [HR] 0.90; 95% CI, 0.81-0.99; P=.04). As for safety, treatment with ticagrelor was associated with a higher incidence of TIMI major bleeding (2.2% vs 1.0% for placebo; HR 2.32; 95% CI, 1.82-2.94; P <.001), and intracranial hemorrhage (0.7% vs 0.5% for placebo; HR 1.71; 95% CI, 1.18-2.48; P =.005). However, there was no significant difference between groups with regard to fatal bleeding (0.2% in the ticagrelor group vs 0.1% in the placebo group; HR 1.90; [95% CI, 0.87-4.15]; P =.11)

Commenting on the approval, Deepak L. Bhatt, MD, MPH, THEMIS trial Co-Chair, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, and Professor of Medicine at Harvard Medical School, Boston, US said: “The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients.”

Earlier this year, AstraZeneca announced positive findings from the phase 3 THALES trial, which investigated ticagrelor plus aspirin in patients with minor acute ischemic stroke or high-risk transient ischemic attack in the 24 hours prior to treatment initiation. Results showed that treatment with ticagrelor led to a statistically significant and clinically meaningful reduction in the risk of the primary composite end point of stroke and death, compared with aspirin alone.

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Brilinta, a P2Y12 platelet inhibitor, is also indicated to reduce the risk of CV death, MI, and stroke in patients with acute coronary syndrome (ACS) or a history of MI. It is also indicated to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS.

For more information visit astrazeneca-us.com.