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Business Wire 24-Sep-2018 7:00 AM
FARXIGA met the primary composite endpoint of a statistically-significant reduction in hospitalization for heart failure or CV death in a broad patient population
Results confirmed the well-established safety profile of FARXIGA
AstraZeneca today announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for FARXIGA® (dapagliflozin), the broadest SGLT-2 inhibitor CVOT conducted to date. The trial 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 type 2 diabetes (T2D) who have multiple CV risk factors or established CV disease.
In the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, FARXIGA met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE). FARXIGA achieved a statistically-significant reduction in the composite endpoint of hospitalization 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. FARXIGA is not indicated to reduce the risk of CV events or hHF.
Data from DECLARE-TIMI 58 confirmed the well-established safety profile of FARXIGA.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development at AstraZeneca said: "FARXIGA has achieved a statistically-significant and clinically-important reduction in hospitalization for heart failure or CV death in a broad range of patients with type 2 diabetes and cardiovascular risk. The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalizations that result in a considerable societal and economic burden." 1-7
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, commented: "The DECLARE-TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type 2 diabetes by reducing the composite of hospitalization for heart failure or CV death, with a safety profile supportive of broad use."
Detailed trial results will be presented on November 10 at the American Heart Association Scientific Sessions 2018 in Chicago, IL.
INDICATION AND LIMITATIONS OF USE FOR FARXIGA (dapagliflozin) tablets 5 mg and 10 mg
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION FOR FARXIGA
Contraindications
Warnings and Precautions
Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common adverse reactions (=5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs. 6.9% vs. 1.5%), nasopharyngitis (6.6% vs. 6.3% vs. 6.2%), and urinary tract infections (5.7% vs. 4.3% vs. 3.7%).
Use in Specific Populations
Please read US Full Prescribing Information and Medication Guide for FARXIGA
Notes to Editors:
About DECLARE-TIMI 58:DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI-58 is an AstraZeneca-sponsored, randomized, double-blinded, placebo-controlled, multicenter 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).8
DECLARE is part of the extensive DapaCare clinical program for FARXIGA, which will enroll patients in randomized clinical trials, including a wide range of mechanistic studies, and is supported by a multinational real-world evidence study (CVD-REAL). The DapaCare clinical program 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.
About AstraZeneca in Cardiovascular, Renal & Metabolism (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 CVMD diseases and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
About AstraZenecaAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism 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. For more information, please visit http://www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
References
US-22108
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