AstraZeneca, a global, science-led biopharmaceutical company, announced two new randomised, placebo-controlled phase IIIb outcome trials with Forxiga (dapagliflozin), an SGLT-2 inhibitor currently indicated for the treatment of type-2 diabetes. These two large outcome trials will help to define the potential role of dapagliflozin in the management of chronic kidney disease and chronic heart failure respectively, in people with and without type-2 diabetes.
This marks the first time a major outcome trial will be conducted to evaluate the effect of an SGLT-2 inhibitor in chronic kidney disease, for which there are currently few treatment options and a significant unmet medical need.
AstraZeneca also announced the initiation of a series of new mechanistic trials designed to understand the underlying science behind the potential cardiovascular and renal protective signals seen with the SGLT-2 inhibitor class.
These new trials reinforce AstraZeneca’s commitment to Cardiovascular and Metabolic disease (CVMD) as one of its main therapy areas and to dapagliflozin, for which the body of evidence continues to grow with more than 80 completed and ongoing clinical trials and more than a million patients treated to date.
Elisabeth Björk, vice president, head of cardiovascular and metabolic diseases, Global Medicines Development, said “Our transformative clinical research aims to address the multiple risk factors associated with cardiovascular morbidity and mortality, including diabetes, chronic heart failure and chronic kidney disease. By following the science, we are seeking to improve outcomes for millions of patients with cardiovascular disease around the world.”
Professor John McMurray, Professor of Cardiology at the Institute of Cardiovascular and Medical Sciences, University of Glasgow, and a member of the Executive Committee for both the chronic heart failure and chronic kidney disease trials, said, “This partnership between AstraZeneca and the wider clinical community is of great importance in allowing us to investigate the potential benefits of dapagliflozin in chronic heart failure and chronic kidney disease, and potentially to transform the way we view and manage these two conditions which place such a burden on our patients and health care systems.”
There are currently an estimated 200 million people worldwide currently living with chronic kidney disease, and 38 million people living with chronic heart failure.
Dapagliflozin (marketed as Farxiga in the US and Forxiga outside the US) is part of a class of medicines called sodium-glucose cotransporter 2 (SGLT-2) inhibitors used to manage type-2 diabetes, which remove glucose via the kidneys.