FDA Broadens Ticagrelor Indication to Stroke Prevention
The US Food and Drug Administration (FDA) has accredited the antiplatelet agent ticagrelor (Brilinta) to lower the ache for stroke in sufferers with acute ischemic stroke with a National Institutes of Neatly being Stroke Scale (NIHSS) ranking of ≤5 or excessive-ache transient ischemic assault (TIA).
The unusual indication for stroke prevention is in step with fling results from the segment 3 THALES trial, printed in The Fresh England Journal of Remedy closing summer season.
THALES became once performed in extra than 11,000 sufferers who had experienced a minor acute ischemic stroke or excessive-ache TIA and for whom treatment became once initiated within 24 hours of the onset of signs. The sufferers were randomly assigned to catch aspirin plus ticagrelor (90 mg twice day-to-day) or aspirin on my own for 30 days.
The trial demonstrated that ticagrelor plus aspirin diminished the charge of the predominant composite endpoint of stroke and loss of life by 17% (absolute ache discount, 1.1%; hazard ratio, 0.83; 95% CI, 0.71 – 0.96; P = .015), when compared to aspirin on my own.
This became once a statistically critical and clinically critical discount. The first composite endpoint became once driven by a discount in stroke, the company acknowledged in a news delivery.
The ache for extreme bleeding events became once 0.5% amongst sufferers taking aspirin plus ticagrelor and 0.1% for those taking aspirin on my own. The outcomes are in response to the known security profile of ticagrelor, the company notes.
“One in four sufferers who own had a stroke will expertise a second one, with the ache in particular excessive contained in the predominant 30 days,” Clay Johnston, MD, lead investigator for the THALES trial and dean of the Dell Medical College on the University of Texas in Austin, acknowledged in the company news delivery. “The approval of Brilinta in mixture with aspirin is a critical advancement to lower the ache of recurrent stroke and primary extra and tons-awaited excellent news for physicians and sufferers.”
Ideal spring, the FDA cleared ticagrelor to be used with aspirin to lower the ache for a predominant myocardial infarction (MI) or stroke in excessive-ache sufferers with coronary artery disease but no historical past of MI or stroke.
Ticagrelor is moreover indicated to lower the ache for cardiovascular loss of life, MI, and stroke in sufferers with acute coronary syndrome or a historical past of MI.
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