AstraZeneca to present Phase III CVOT DECLARE-TIMI 58 results at AHA Scientific Sessions

Reviewed by Alina Shrourou, B.Sc. (Editor)Nov 1 2018

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 (CVMD) therapy area at the American Heart Association (AHA) Scientific Sessions, November 10-12, 2018, in Chicago, Illinois, USA.

New evidence will build on broad clinical research from AstraZeneca that aims to help redefine the management of CVMD 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 hyperkalemia.

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 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. 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. FARXIGA is not indicated to reduce the risk of CV events, hHF or renal outcomes.

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 ischemic 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 CV events (Oral Presentation #100)

Data will also be presented on potential risk factors for repeated or persistent hyperkalemia (Poster # SuMDP65).