The landmark DECLARE-TIMI 58 cardiovascular outcomes trial of Farxiga in patients with type-2 diabetes to be featured at AHA 2018
New data on cardiovascular effects of long-term Brilinta use in patients with a history of heart attack
Data from 20 abstracts further highlight AstraZeneca’s holistic approach to care in cardiovascular, renal and metabolic diseases
AstraZeneca will present 20 abstracts including a late-breaking oral presentation on the full results from the Phase III cardiovascular (CV) outcomes trial (CVOT) DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58, the broadest SGLT2 inhibitor CVOT conducted to date, as well as new research from the Company’s Cardiovascular, Renal & Metabolism (CVRM) therapy area at the American Heart Association (AHA) Scientific Sessions, 10-12 November 2018, in Chicago, Illinois, USA.
New evidence will build on broad clinical research from AstraZeneca that aims to help redefine the management of CVRM diseases and address the need for a more proactive and holistic approach to patient care. Presentations will include findings from some of the largest trials in broad patient populations with Farxiga (dapagliflozin) in type-2 diabetes (T2D), Brilinta (ticagrelor) in patients with a history of heart attack, and in hyperkalaemia.
Danilo Verge, Vice President, Cardiovascular, Renal & Metabolism, Global Medical Affairs, said: “An estimated 20 million people each year die from cardiovascular, renal and metabolic diseases, yet shared risk factors are frequently not diagnosed or addressed holistically. Our data at AHA reflect an integrated approach to managing the needs of patients living with type-2 diabetes and risk of cardiovascular or renal disease, and those with a history of cardiovascular disease at acute and long-term risk of recurrence. We stand firmly behind our mission to provide new solutions earlier in disease management to these patients at risk for multiple complications.”
DECLARE-TIMI 58: a landmark CVOT evaluating CV risk in patients with T2D
Clinical trial results showing the safety and efficacy of Farxiga vs. placebo on primary CV and secondary renal efficacy outcomes in adults with T2D who have multiple CV risk factors or established CV disease, will be presented in a late-breaking oral presentation (Late Breaking Abstract #19485). DECLARE-TIMI 58 evaluated the CV outcomes of Farxiga vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with T2D with multiple CV risk factors or established CV disease.
In September 2018, AstraZeneca announced that Farxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE) and achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death, one of the two primary efficacy endpoints. Additionally, fewer MACE events were observed with Farxiga for the other primary efficacy endpoint, however, this did not reach statistical significance. Clinical trial results presented at AHA Scientific Sessions 2018 will include additional details on the primary CV safety and efficacy, as well as secondary renal efficacy outcomes from DECLARE-TIMI 58.
Three new sub-analyses from the PEGASUS-TIMI 54 trial will also be presented. The trial compared Brilinta (90mg or 60mg twice daily) plus aspirin vs. aspirin alone in 21,162 patients with prior (1 to 3 years) heart attack. The sub-analyses evaluate:
- Whether clinical characteristics predicting bleeding and ischaemic risk identify subgroups of patients who may derive benefit from long-term treatment with Brilinta, with a lower risk of major bleeding (Poster #Sa2100)
- The effects of long-term use of Brilinta in patients who have had a heart attack and who did not receive a coronary stent vs. those who did receive a coronary stent placement (Oral Presentation #102)
- The use of high-sensitivity cardiac troponin to identify patients who are at a higher-risk of major cardiovascular events (Oral Presentation #100)
Data will also be presented on potential risk factors for repeated or persistent hyperkalaemia (Poster # SuMDP65).
Key abstracts at the AHA Scientific Sessions 2018:
|Abstract title||Presentation details|
|The Dapagliflozin Effect on Cardiovascular Events (DECLARE)–TIMI 58 Trial||Late Breaking Abstract #19485Saturday Nov 10, 3:45 PM - 4:00 PMSession: LBS.02. Late Breaking Clinical Trial: Novel Approaches to CV Prevention|
|Long-Term Secondary Prevention with Ticagrelor for Prior Myocardial Infarction in Patients with no Coronary Stenting: A Sub-analysis from PEGASUS TIMI 54||Oral Presentation #102
Sunday November 11, 4:15 PM - 4:25 PM Session: AC.AOS.01, S103bc. Advances in the Prediction and Modification of Cardiovascular Disease Risk
|High-sensitivity Cardiac Troponin at Any Detectable Concentration Identifies Higher Risk of Major Cardiovascular Events in Patients with Stable Ischemic Heart Disease||Oral Presentation #100November 11, 3:45 PM - 3:55 PMSession: AC.AOS.01, S103bc. Advances in the Prediction and Modification of Cardiovascular Disease Risk|
|Method of Assessing Medication Persistence and Clinical Outcomes: A Comparison of Patient Report and Pharmacy Fill Data from the ARTEMIS Trial||Oral Presentation #452November 11, 2:45 PM - 2:50 PMSession: QU.RFO1. ACS Top QCOR Abstracts: Rapid Fire|
|Impact of Coronary Artery Disease Severity on Risk of Cardiovascular Disease in Type 2 Diabetes Patients: A Swedish Nationwide Observational Study||Poster # Su1297, 1297November 11, 10:30 AM - 11:45 AM Session: QU.APS.03. Acute and Chronic Coronary Artery Disease: Quality Care and Outcomes|
|Patient Selection for Long-Term Prevention of Limb Ischemic Events||Oral Presentation (Rapid Fire) #419November 10, 2:15 PM - 3:30 PMSession: VA.RFO1. Understanding Risk and Mechanisms of Critical Limb Ischemia: Lessons from the Long CLImb|
|Patient Selection for Long-Term Secondary Prevention with Ticagrelor: Insights from PEGASUS-TIMI 54||Poster #Sa2100, 2100November 10, 2:15 PM - 3:30 PMSession: AC.APS.09. Pharmacotherapy in ACS and Stable Ischemic Heart Disease|
|Caffeine and Dyspnea With Ticagrelor: A Sub-analysis From PEGASUS TIMI-54 Trial||Poster #2097, Sa2097November 10, 2:15 PM - 3:30 PMSession: AC.APS.09. Pharmacotherapy in ACS and Stable Ischemic Heart Disease|
|The 'Halo Effect" of a P2Y12 Inhibitor Copayment Reduction Intervention on Adherence and Persistence with other Cardiovascular medications: Results from the ARTEMIS Cluster Randomized Trial||Poster #Sa2098, 2098November 10, 2:15 PM - 3:30 PMSession: AC.APS.09. Pharmacotherapy in ACS and Stable Ischemic Heart Disease|
|What Characterizes the Patients who Develop Repeated or Persistent Hyperkalaemia?||Poster # SuMDP65November 11, 11:45 AM - 12:55 PMSession: HF.MDP2. Interesting Topics in Heart Failure and Cardiomyopathy|
– ENDS –
NOTES TO EDITORS
About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)
Cardiovascular, renal and metabolism together form one of AstraZeneca’s main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys 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 CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
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, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
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