FDA Broadens Ticagrelor Indication to Stroke Prevention


The US Meals and Drug Administration (FDA) has authorised the antiplatelet agent ticagrelor (Brilinta) to cut back the chance for stroke in sufferers with acute ischemic stroke with a Nationwide Institutes of Well being Stroke Scale (NIHSS) rating of ≤5 or high-risk transient ischemic attack (TIA).

The brand new indication for stroke prevention relies on constructive outcomes from the part 3 THALES trial, printed in The New England Journal of Medication final summer season.

THALES was carried out in additional than 11,000 sufferers who had skilled a minor acute ischemic stroke or high-risk TIA and for whom therapy was initiated inside 24 hours of the onset of signs. The sufferers had been randomly assigned to obtain aspirin plus ticagrelor (90 mg twice every day) or aspirin alone for 30 days.

The trial demonstrated that ticagrelor plus aspirin diminished the speed of the first composite endpoint of stroke and demise by 17% (absolute threat discount, 1.1%; hazard ratio, 0.83; 95% CI, 0.71 – 0.96; P = .015), in comparison with aspirin alone.

This was a statistically important and clinically significant discount. The first composite endpoint was pushed by a discount in stroke, the corporate stated in a information launch.

The danger for extreme bleeding occasions was 0.5% amongst sufferers taking aspirin plus ticagrelor and 0.1% for these taking aspirin alone. The outcomes are in keeping with the identified security profile of ticagrelor, the corporate notes.

“One in 4 sufferers who’ve had a stroke will expertise a second one, with the chance notably excessive inside the first 30 days,” Clay Johnston, MD, lead investigator for the THALES trial and dean of the Dell Medical College on the College of Texas in Austin, stated within the firm information launch. “The approval of Brilinta together with aspirin is a vital development to cut back the chance of recurrent stroke and much-awaited excellent news for physicians and sufferers.”

Final spring, the FDA cleared ticagrelor to be used with aspirin to chop the chance for a primary myocardial infarction (MI) or stroke in high-risk sufferers with coronary artery disease however no historical past of MI or stroke.

Ticagrelor can also be indicated to cut back the chance for cardiovascular demise, MI, and stroke in sufferers with acute coronary syndrome or a historical past of MI.

For extra Medscape Neurology information, be a part of us on Facebook and Twitter.