AstraZeneca’s CVD-REAL study shows SGLT-2 inhibitors significantly reduced death and hospitalisations for heart failure versus other type-2 diabetes medicines

Landmark real-world evidence from an international study of more than 300,000 patients with type-2 diabetes showed treatment with SGLT-2 inhibitors reduced all-cause mortality by 51% and risk of hospitalisation for heart failure by 39%  

CVD-REAL data are presented at the American College of Cardiology 66th Annual Scientific Session

19 March 2017

AstraZeneca today announced results of the first large real-world evidence study of its kind evaluating the risk of hospitalisation for heart failure and death from any cause in patients with type-2 diabetes (T2D) receiving treatment with a newer class of diabetes medicines, SGLT-2 inhibitors (SGLT-2i).¹

The CVD-REAL study assessed data from more than 300,000 patients across six countries, 87% of whom did not have a history of cardiovascular disease. The data showed that across this broad population of patients with T2D, treatment with SGLT-2i medicines - Farxiga (dapagliflozin), canagliflozin, empagliflozin - reduced the rate of hospitalisation for heart failure by 39% (p<0.001) and death from any cause by 51% (p<0.001), compared to other T2D medicines. For the composite endpoint of hospitalisation for heart failure and death from any cause, the reduction was 46% (p<0.001).¹

Worldwide, diabetes affects around 415 million adults, a number estimated to rise to 642 million by 2040 (1 in 10 adults).² People with T2D have a 2-3 times greater risk of heart failure and are at an increased risk of having a heart attack or stroke, and some 50% of deaths in people with T2D are caused by cardiovascular disease.^3,4,5

Bruce Cooper, MD, Vice President and Head of Global Medical Affairs at AstraZeneca, said: “Diabetes is a growing epidemic worldwide, which is associated with significant comorbidities that contribute to an increased risk of costly hospitalisations and even death.^6,7 Real-world data from this study provide striking evidence that the newer SGLT-2i class of medicines cuts the rate of hospitalisations for heart failure and death by approximately half. CVD-REAL is the first study to observe these effects of SGLT-2i treatment in a much broader and lower risk group of type-2 diabetes patients than previously evaluated in clinical trials.”

The hospitalisations for heart failure analysis was conducted using anonymised patient data from Denmark, Germany, Norway, Sweden, United Kingdom and the United States. Of the data reviewed, 41.8% of patients were on Farxiga (dapagliflozin), 52.7% on canagliflozin and 5.5% on empagliflozin. The analysis of death from any cause was conducted using anonymised patient data from Denmark, Norway, Sweden, United Kingdom and the United States. Of the data reviewed, 51.0% of patients were on Farxiga (dapagliflozin), 42.3% on canagliflozin and 6.7% on empagliflozin.

This is the first of several comparative analyses of CVD-REAL. The collection of real-word evidence is ongoing and future analyses will be conducted using this dataset as well as data from additional countries. All the data for the study were obtained from anonymised real-world sources including medical records, claims databases and national registers. The analysis was validated by the independent academic statistical group at St. Luke’s Mid America Heart Institute, Kansas City, US.

NOTES TO EDITORS

About Dapagliflozin (Farxiga) Clinical Trials Programme
Dapagliflozin (marketed as Farxiga in the US and Forxiga outside the US) is part of a class of medicines called sodium-glucose cotransporter 2 inhibitors (SGLT-2i) used to manage type-2 diabetes, which remove glucose via the kidneys.

Farxiga (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes. Farxiga is not indicated to reduce the risk of CV events, death or hospitalisation for heart failure.

There are three ongoing outcomes trials for dapagliflozin. DECLARE is a robust randomised, double-blind, multicentre, placebo-controlled cardiovascular outcomes trial enrolling more than 17,000 patients around the world, designed to evaluate the cardiovascular outcomes of dapagliflozin compared with placebo in addition to standard of care, in adults with T2D and high risk of cardiovascular disease (either established cardiovascular disease or multiple cardiovascular risk factors). DECLARE is ongoing and expected to provide data in 2019 at the latest. In addition to DECLARE, AstraZeneca has initiated two outcomes trials, the DAPA-HF and DAPA-CKD trials, to help to define the potential role of dapagliflozin in the management of chronic heart failure and chronic kidney disease respectively, in people with and without type-2 diabetes. Dapagliflozin is not indicated to reduce the risk of cardiovascular events, death, heart failure or the progression of chronic kidney disease.

About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a core therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination product approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

About AstraZeneca in Cardiovascular and Metabolic Diseases
Cardiovascular, renal and metabolic diseases are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. By collaborating across therapeutic disciplines within the CVMD therapy area, we are addressing the underlying disorders that drive CVMD risk, with the goal of reducing morbidity, mortality and organ damage through innovative therapies. Recognising the growing unmet needs and challenges faced by the millions of people worldwide living with these interrelated diseases, we are determined to understand how they interact and impact one another – and how they can be treated together to save more patients’ lives.

About AstraZeneca
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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

References

1. The CVD-REAL Study: Lower Rates of Hospitalization for Heart Failure in New Users of SGLT-2 Inhibitors Versus Other Glucose Lowering Drugs — Real-World Data From Four Countries and More Than 360,000 Patients; presented 19 March at ACC 2017
2. International Diabetes Federation. Facts and Figures. Accessed 15 March 2017 http://www.idf.org/WDD15-guide/facts-and-figures.html
3. Nwaneri C, Cooper H, Bowen-Jones D. Mortality in type 2 diabetes mellitus: magnitude of the evidence from a systematic review and meta-analysis. The British Journal of Diabetes & Vascular Disease. 2013;13(4):192-207
4. Morrish NJ, et al. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44 Suppl 2:S14-21.
5. World Heart Federation. Diabetes as a risk factor for cardiovascular disease. Available from: http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/
6. World Health Organization. Media Centre: Diabetes Fact Sheet. Reviewed November 2016. Accessed 9 March 2017. http://www.who.int/mediacentre/factsheets/fs312/en/
7. American Diabetes Association. The Cost of Diabetes. Accessed 9 March 2017 http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html?referrer=https://www.google.com/

CONTACTS