FDA approves ticagrelor-aspirin DAPT to reduce MI, stroke in CAD
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Ticagrelor has been approved by the FDA to reduce risk for first MI or stroke in high-risk patients with CAD.
This decision marks the first regulatory approval for dual antiplatelet therapy with aspirin plus ticagrelor in patients with high CV risk without a history of MI or stroke, according to a press release from AstraZeneca.
The FDA approval of ticagrelor (Brilinta) was based on findings from the phase 3 THEMIS trial, according the release. As Healio previously reported, ticagrelor added to low-dose aspirin reduced the incidence of ischemic events in patients with stable CAD and diabetes without a history of MI or stroke compared with aspirin alone. During a median follow-up of 39.9 months, the primary efficacy outcome — a composite of CV death, MI or stroke — occurred in 7.7% of patients assigned 60 mg ticagrelor vs. 8.5% assigned placebo (HR = 0.9; 95% CI, 0.81-0.99).
“Around one-third of patients with coronary artery disease have type 2 diabetes, putting them at higher risk of heart attack or stroke than patients without diabetes,” P. Gabriel Steg, MD, director of the coronary care unit in the cardiology department at Hôpital Bichat, Paris, professor of cardiology at the Université Paris – Diderot and co-chair of the THEMIS trial, said in the release. “Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke.”
“Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people,” Cardiology Today Editorial Board Member Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center, professor of medicine at Harvard Medical School and co-chair of the THEMIS trial, said in the release. “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.”
“This new indication is a further testament to the overwhelming science supporting Brilinta in the management of patients with coronary artery disease at high risk for cardiovascular events,” Ruud Dobber, executive vice president of the biopharmaceuticals business unit at AstraZeneca, said in the release.
Disclosures: The THEMIS trial was funded by AstraZeneca. Steg reports he has research contracts with AstraZeneca, Amarin, Bayer, Sanofi and Servier, and other ties with Amarin, Amgen, AstraZeneca, Bayer/Janssen, Boehringer Ingelheim, Bristol-Myers Squibb, Idorsia, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi and Servier. Bhatt reports he has financial ties with numerous drug and device companies, including receiving research funding from AstraZeneca. Dobber is an employee of AstraZeneca.
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