Brilinta hits endpoint in late-stage stroke trial

AstraZeneca has revealed results from its Brilinta (ticagrelor) trial, demonstrating that the drug showed a statistically significant and clinically meaningful reduction in the risk of stroke and death, compared to aspirin alone.

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In the Phase III THALES trial, 90mg of the treatment used twice daily and taken with aspirin for 30 days also achieved safety profiles consistent with the known profile of Brilinta, with an increased bleeding rate in the treatment arm.

The study was conducted in over 11,000 patients who had a minor acute ischaemic stroke or high-risk transient ischaemic attack, and patients were randomised within 24 hours of onset of acute ischaemic stroke or high-risk transient ischaemic attack symptoms and followed-up for 30 days of treatment.

Detailed results have not yet been shared, but Dr Clay Johnston, lead investigator for the THALES trial said: “The risk of having a subsequent stroke is highest in the first few days and weeks after a minor acute ischaemic stroke or high-risk transient ischaemic attack. While an expected increase in bleeding was observed, the findings from THALES showed that Brilinta, in combination with aspirin, reduced the risk of potentially devastating events in this crucial time.”

As it stands, the treatment is approved in more than 110 countries for the treatment of acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular (CV) events among high-risk patients who have experienced a heart attack.

Stroke is the second leading cause of death worldwide, with 6.2 million stroke-related deaths in 2017, from which 2.7 million were due to ischaemic stroke.

28th January 2020

http://www.pharmatimes.com/

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