AstraZeneca today announced results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29% risk reduction in CV death (p=0.0041) from treatment with Brilinta (ticagrelor) 60mg twice daily, versus placebo, in patients taking low-dose aspirin but still at high risk of an atherothrombotic event, a major cause of acute coronary syndrome and CV death.
Patients received Brilinta within two years of having a heart attack (myocardial infarction, MI) or within one year of stopping anti-platelet treatment with an adenosine diphosphate (ADP) inhibitor. The latest results highlight a potential protective CV benefit associated with longer-term treatment, versus the standard 12-month post-event treatment period, with Brilinta 60mg, and are due to be presented in full at the ESC Congress in Barcelona, Spain.
The favourable benefit-risk ratio for extended dual anti-platelet treatment with Brilinta 60mg was suggested earlier in the PEGASUS trial that provided the data supporting the European Medicines Agency’s approval of Brilinta in the post-MI indication.
Mikael Dellborg, Professor of Cardiology at the University of Gothenburg and member of the Steering Committee of the PEGASUS-TIMI 54 trial, said: "The conclusion for both clinicians and patients at high-risk of CV death post-MI is clear: Treatment with Brilinta 60mg, either as continuation therapy after the initial 12 month post-event period, or with as limited interruption as possible, is associated with a clear and favourable benefit-risk ratio for this population of patients. This new insight is potentially practice-changing, as while more than seven million people worldwide suffer a heart attack each year, we know that fewer than half receive adequate long-term treatment to reduce their risk of further CV events."
The sub-analysis of PEGASUS-TIMI 54 data also showed a risk reduction of 20% in all causes of death, and 20% in the composite of CV death, MI or stroke. As expected, major bleeding rates were consistent with the known safety profile of Brilinta.
Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases (CVMD), Global Medicines Development, AstraZeneca, said: "The Phase III PEGASUS-TIMI 54 trial continues to provide valuable data and insights with the potential to benefit both healthcare professionals and their patients. The results reinforce the importance of our continued investment in the science, helping to understand better the unique CV and mortality benefits that our medicines, such as Brilinta, can provide for the millions of patients living with cardiovascular disease, the leading cause of death globally(1)."
About Brilinta (ticagrelor)
Brilinta is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilinta works by inhibiting platelet activation and has been shown to reduce the rate of atherothrombotic CV events, such as heart attack or CV death, in patients with acute coronary syndromes (ACS).
Brilinta, co-administered with aspirin, also known as acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with ACS, or for patients with a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVMD)
Cardiovascular, renal and metabolic diseases together form one of AstraZeneca’s main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMDs and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVMD health for millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
1. World Health Organization. Cardiovascular diseases (CVDs) Fact Sheet. Accessed 17 August 2017 http://www.who.int/mediacentre/factsheets/fs317/en