First sub-analyses from the DECLARE-TIMI 58 trial further support the cardiovascular effects of Farxiga in type-2 diabetes
Farxiga reduced major adverse cardiovascular events by 16% in patients who had a prior heart attack
Farxiga reduced hospitalisation for heart failure regardless of ejection fraction status
Positive results from a pre-specified sub-analysis of the Phase III DECLARE-TIMI 58 trial showed that Farxiga (dapagliflozin) reduced the relative risk of major adverse cardiovascular events (MACE) by 16% compared to placebo in patients with type-2 diabetes (T2D) who had a prior heart attack (myocardial infarction).
In another pre-specified sub-analysis, Farxiga compared to placebo reduced the relative risk of hospitalisation for heart failure (hHF) in patients with T2D regardless of their ejection fraction (EF) status, a measurement of the percentage of blood leaving the heart with each contraction.
The data were presented today at the American College of Cardiology’s (ACC) 68th Annual Scientific Session, New Orleans, USA and were published in Circulation.1,2
Elisabeth Björk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, said: “These data build upon the existing evidence of the cardio-renal effects of Farxiga, with important new evidence on heart failure and MACE. Heart failure is one of the most common early cardiovascular complications of type-2 diabetes. Despite advances in healthcare, it remains as life-threatening and prevalent as the combined incidence of the top-four most common forms of cancer. Therefore, more needs to be done for patients.”
Dr. Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, a senior investigator with the Thrombolysis in Myocardial Infarction (TIMI) study group and co-principal investigator of the trial, said: “Data from these pre-specified sub-analyses offer important and clinically-relevant insights for cardiologists and their patients. We now have new evidence from DECLARE-TIMI 58 that shows Farxiga consistently reduced hospitalisation for heart failure across a broad range of patients with type-2 diabetes, regardless of their history of existing CV disease, including heart attack, or heart failure.”
These pre-specified sub-analyses of DECLARE-TIMI 58 add to the positive primary results of the trial presented in November 2018, which showed that Farxiga significantly reduced the risk of the composite of hHF or CV death compared to placebo, consistently across the trial’s entire patient population. Additionally, there were fewer major adverse cardiovascular events observed with Farxiga in the broad patient population, however this did not reach statistical significance.
Farxiga is a selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2 inhibitor) indicated as monotherapy and as part of combination therapy to improve glycaemic control in adult patients with T2D. Farxiga is not indicated to reduce the risk of CV events, heart failure or death.
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NOTES TO EDITORS
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an AstraZeneca-sponsored, randomised, double-blinded, placebo-controlled, multicentre trial designed to evaluate the effect of Farxiga compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease. DECLARE included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).
DECLARE is part of the extensive DapaCare clinical programme for Farxiga, which will enrol patients in randomised clinical trials including a wide range of mechanistic trials and is supported by a multinational real-world evidence study (CVD-REAL). The DapaCare clinical programme will generate data across a spectrum of people with CV risk factors, established CV disease and varying stages of renal disease, both with and without T2D. DECLARE is paving the way for three Phase III trials: Dapa-HF, DELIVER and Dapa-CKD. Farxiga is not indicated to reduce the risk of CV events, CV death, or hHF, or the treatment of CKD.
Farxiga (dapagliflozin) is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with T2D. Farxiga has a robust clinical trial programme of more than 35 completed and ongoing Phase IIb/III trials in over 35,000 patients, as well as more than 1.8 million patient-years’ experience.
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. For more information, please visit astrazeneca.com and follow us on Twitter @AstraZeneca.
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1. Kato ET, Silverman MG, Mosenzon O, et al. Effect of dapagliflozin on heart failure and mortality in type 2 diabetes mellitus. Circulation.
2. Furtado RHM, Bonaca MP, Raz I, et al. Dapagliflozin and cardiovascular outcomes in patients with type 2 diabetes and prior myocardial infarction - a sub-analysis from DECLARE TIMI-58 trial. Circulation.