AstraZeneca Brinlinta approved by FDA for high-risk coronary artery disease patients

Pharmaceuticals,63 (AP) announced that the U.SFood and Drug Administration (FDA) has approved the anticoagulant brilinta (tecagrad) for use in patients with high-risk coronary artery disease (CAD) to reduce the risk of a first heart attack or strokeCAD is the most common type of heart diseaseThis approval is based on positive results in the Cardiovascular Prognosis Phase III THEMIS studyThe trial showed that in patients with both cad and type 2 diabetes (T2D) with a high risk of having a first heart attack or stroke, 36 months after treatment, Brilinta (60mg) combined aspirin significantly decreased significantly in the major compound endpoints of major adverse cardiovascular events (MACE) compared to aspirinThe main compound endpoints are driven by a decrease in heart attacks and strokesIt is worth mentioning that this approval is the first regulatory approval of Brinlinta combined aspirin dual antiplatelet therapy in a group of patients with a high cardiovascular risk but no history of heart attack or strokeExpand the population of Brinlinta to high-risk coronary heart disease patients with no history of heart attack or stroke"CAD is a potentially life-threatening disease that causes serious morbidity in many people," said Deepak LBhatt, co-chair of the THEMIS trial and executive director of the Cardiovascular Intervention Program at the Bregan and Women'sHospitaland professor of medicine at Harvard Medical SchoolThe addition of Brinlinta to aspirin provides a new treatment option for reducing the likelihood of heart attacks and strokes, a significant improvement in our ability to treat these high-risk patients"The THEMIS trial is a large-scale, multi-country trial involving more than 19,000 patients with CAD and type 2 diabetes," said DrGabriel Steg, a professor at the University of Paris, co-chair of theTHEMIS trialAbout one-third of CAD patients have type 2 diabetes, making them more likely to have a heart attack or stroke than those without diabetes Today's approval offers new hope for patients at risk of a first-time heart attack or stroke Ruud Dobber, executive vice president of AstraZeneca Biopharmaceuticals, said: "Today's approval of Brilinta is important news for the CAD patient community, who will now have a new treatment option that reduces the risk of a first heart attack or stroke This new indication is further evidence of the overwhelming science that supports Brinlinta's treatment of high-risk CAD patients with cardiovascular events "
THEMIS (Tikagra's Intervention On The Effects of Health Prognosis for
Diabetics) was launched in early 2014 as a randomized, double-blind study sponsored by AstraZeneca in several countries in more than 19,000 patients with out-of-the-heart attacks (myocardial infarction, MI) or stroke, coronary heart disease (CAD) and type 2 diabetes (T2D) The purpose of the study was to test the hypothesis that tikagrad-aspirin can reduce major adverse cardiovascular events (MACE, cardiovascular death, myocardial infarction, or stroke) compared to aspirin CAD is defined as epidermal coronary artery interventional therapy (PCI), bypass surgery, or coronary artery stenosis of at least 50% The study was conducted in 42 countries in Europe, Asia, Africa, North And South America THEMIS-PCI is a clinically significant pre-designated subgroup analysis of patients who have previously received epidermal coronary artery interventiontherapy (PCI) (11,154 cases, or 58% of the total number of patients) 　　The results showed that the study reached its main endpoint: the relative risk of major adverse cardiovascular events (MACE) was statistically significantly significantly reduced by 10% compared to aspirin (absolute risk reduction: 0.8%; 7.7% vs 8.5% ;) In addition, in the THEMIS-PCI subgroup analysis, the relative risk of Tikagray combined aspirin reduced MACE by 15% compared to aspirin In this study, the safety results of Ticagray were consistent with the known safety profile of the drug An increased risk of bleeding events was observed in both THE THEMIS and THEMIS-PCI subgroups 　　Coronary heart disease (CAD) is the most common type of heart disease Ischemic heart disease is the leading cause of men's loss of healthy life expectancy due to disability, and is the second leading cause of loss of healthy life expectancy due to disability women Patients with CAD and T2D at the same time had diseases with atherosclerosis burden significantly higher than those without T2D 　　The results from the THEIMS trial and the THEMIS-PCI subgroup analysis were published in the New England Journal of Medicine and The Lancet, respectively At present, regulatory reviews in the European Union, Japan and China are under way to expand Brinlinta's indications based on the results of the THEIMS trial 　　More recently, AstraZeneca also published high levels of cardiovascular prognosis Phase III THALES trials, which showed that aspirin combined with Brinlinta (90 mg) reduced the compound risk of stroke and death within 30 days of acute ischemic stroke or transient ischemic seizures than aspirin alone 　　To date, Brinlinta has been approved in more than 110 countries worldwide for the prevention of atherosclerosis thrombosis events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for high-risk patients who have experienced a myocardial infarction, secondary prevention of CV events 　　Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation In patients with acute coronary syndrome (ACS) or a history of myocardial infarction, Brilinta combined aspirin has been shown to significantly reduce the risk of major adverse cardiovascular events (myocardial infarction, stroke, or cardiovascular death) 　　Brilinta Combined Aspirin program sits in adult patients with ASC, or in patients with a history of myocardial infarction and high risk of atherosclerosis thrombosis events, to prevent atherosclerosis thrombosis events 　　Original source: Brilintaapproved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease