AstraZeneca trial findings contribute to diabetes Standards of Care

Janssen presents initial results for BCMA CAR-T therapy

The American Diabetes Association (ADA) has issued critical updates to the Standards of Medical Care in Diabetes (Standards of Care) based on recently published research, including data from the landmark DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT).

Specifically, three sections were updated to incorporate data related to hospitalisations for heart failure (hHF) and progression of chronic kidney disease (CKD) from AstraZeneca’s DECLARE-TIMI 58 trial. The updates were issued in annotations as the Living Standards of Care.

DECLARE-TIMI 58 is the largest and longest SGLT-2 inhibitor CVOT studied across a broad range of type 2 diabetes (T2D) patients and the first to include the composite of hHF or CV death as a primary endpoint. The trial included nearly 60% of patients with multiple CV risk factors, making it the largest primary prevention population of the SGLT-2i CVOTs.

Heart failure is the number one cardiac complication in type 2 diabetes, and patients with type 2 diabetes have a two-to-five times greater risk of heart failure along with an increased risk of other cardiovascular complications like heart attack or stroke. Diabetes is the leading cause of chronic kidney disease, and approximately one out of four adults with diabetes has kidney disease.

The update to the 2019 ADA Standards of Medical Care in Diabetes follows the publication of the American College of Cardiology (ACC) and American Heart Association (AHA) Primary Prevention Guideline, and the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) Comprehensive Type 2 Diabetes Management Algorithm, both of which incorporate data from DECLARE-TIMI 58 and reinforce the role of SGLT-2 inhibitors in reducing renal and cardiovascular risk, including heart failure.

The ADA, ACC/AHA, and AACE/ACE treatment guidelines include unapproved uses of FARXIGA (dapagliflozin). FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not indicated to reduce the risk of CV events including HF, renal outcomes or death.

Rod Wooten, Senior Vice President, US Cardiovascular and Metabolic Diseases, AstraZeneca said: “We are pleased the American Diabetes Association worked quickly to incorporate new data into clinical practice guidance to help empower healthcare professionals to provide evidence-based care and help improve these outcomes for the millions of Americans living with diabetes.”

Full results from the DECLARE-TIMI 58 trial were presented at the American Heart Association Scientific Sessions in November 2018.