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2017-03-19

AstraZeneca: AZ's CVD-real study shows SGLT-2 inhibitors significantly reduced death and hospitalisations for heart failure versus other type-2 diabetes medicin

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

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).2People
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.6,7Real-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.

- ENDS -

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/cardiovascul...

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?refer...

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