PHILADELPHIA––AstraZeneca’s longtime clot-buster Brilinta has seen some of its shine wear off as other drugs––not the least of which SGLT2 star Farxiga––have charted a new course. But the British drugmaker still has hopes for its old stalwart, and aspirin-beating bleeding data in acute coronary syndrome (ACS) could help.
Solo Brilinta beat out a Brilinta-aspirin combo on the safety side, reducing clinically relevant bleeding while matching up on efficacy. The results came after 12 months in acute coronary syndrome patients who underwent a percutaneous coronary intervention with at least one stent.
Those data were presented Saturday at the American Heart Association Scientific Sessions, as part of a subgroup analysis from Brilinta’s phase 3 Twilight trial. On top of beating out dual-platelet therapy in reduced bleeding, solo Brilinta stood up to the Brilinta-aspirin combo in adverse CV events, including all-cause death, heart attacks and stroke.
The subanalysis included 64% of the Twilight trial population. Following a three-month open-label period treating patients with Brilinta and aspirin, 4,614 patients free of ischemic events and bleeding were continued on either solo Brilinta or the Brilinta-aspirin combo.
Patients treated with solo Brilinta posted a 53% relative risk reduction in types 2, 3 and 5 bleeding after one year, according to the Bleeding Academic Research Consortium (BARC) ratings. Specifically in types 3 and 5, Brilinta alone posted a 64% relative risk reduction over the dual therapy.
Naeem Khan, AstraZeneca’s medical VP of cardiovascular and metabolic disease, said the newest data challenged a more than 20-year-old standard of dual-platelet therapy in treating ACS.
“This is a paradigm shift in thinking about dual therapy,” Khan said.
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The subanalysis helps builds Brilinta’s case for ACS patients after the completion of its Twilight trial studying Brilinta as an add-on to aspirin in treating the syndrome.
Back in February, Brilinta added to aspirin slashed the combined risk of heart attack, stroke and cardiovascular death in patients with Type 2 diabetes with coronary artery disease (CAD) who hadn’t suffered a prior heart attack or stroke. The combination topped aspirin alone in the 19,000-plus patient trial, a phase 3 study dubbed Themis.
