Trial sub-analyses support CV effects of Farxiga in T2D

AstraZeneca and Daiichi Sankyo announce positive top-line results for pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan

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 at the American College of Cardiology’s (ACC) 68th Annual Scientific Session, New Orleans, U.S., 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 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.

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.”

Joris Silon, Senior Vice President, Cardiovascular, Renal and Metabolism BioPharmaceuticals, AstraZeneca, added: “Our data at ACC reinforce the overall strength of the Farxiga clinical research programme through these first pre-specified sub-analyses evaluating key outcomes in patients with prior-MI and with heart failure in the DECLARE-TIMI 58 trial.

“The size and scope of DECLARE-TIMI 58 uniquely allows us to dig deeper into specific patient populations of high medical interest, demonstrating the ability of Farxiga to address cardio-renal complications associated with type-2 diabetes. We believe this is a distinctive approach to research that offers highly relevant insights to help change clinical practice.”

Farxiga is not indicated to reduce the risk of CV events, heart failure or death.