Therapy Areas: Oncology
First Sub-Analyses from the DECLARE-TIMI 58 Trial Further Support the Cardiovascular Effects of Farxiga in Type 2 Diabetes
20 March 2019 - - 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 by 16% compared to placebo (15.2% vs 17.8%; HR 0.84, [95% CI 0.72-0.99]) in patients with type 2 diabetes who had a prior heart attack (myocardial infarction), British-Swedish drugmaker AstraZeneca said.

In another pre-specified sub-analysis, Farxiga compared to placebo reduced the relative risk of hospitalisation for heart failure in patients with T2D regardless of their ejection fraction status, a measurement of the percentage of blood leaving the heart with each contraction.

Farxiga reduced hospitalization for heart failure by 36% in patients with HF reduced ejection fraction (HFrEF) (13.5% vs 19.0%; HR 0.64, [95% CI, 0.43-0.95]) and by 24% in patients without HFrEF (2.1% vs 2.7%; HR 0.76, [95% CI 0.62-0.92]).

The data were presented TODAY at the American College of Cardiology's 68th Annual Scientific Session, New Orleans, USA and were published in Circulation.

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 indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga is not indicated to reduce the risk of CV events, HF, or death.

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 enroll patients in randomized 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.

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.

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 and Metabolism and Respiratory.

AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
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