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2018-03-11

AstraZeneca: New data from landmark CVD-REAL study of patients with type-2 diabetes confirms CV benefits associated with SG...

Real-world evidence study of more than 400,000 patients with type-2
diabetes, 74% of whom did not have a history of established
cardiovascular disease, supports the association of CV benefits with
use of

Latest analysis includes heart attack and stroke endpoints, longer
follow-up period and six additional countries across Asia Pacific,
the Middle East and North America

AstraZeneca today announced results from a new analysis of its
landmark CVD-REAL study, the first large real-world evidence study of
its kind evaluating the risk of all-cause death (ACD),
hospitalisation for heart failure (hHF), heart attack (myocardial
infarction or MI) and stroke in patients with type-2 diabetes (T2D)
receiving treatment with SGLT-2 inhibitors (SGLT-2i), including
Farxiga (dapagliflozin) versus other glucose-lowering medicines. The
results were presented as a late breaker at the American College of
Cardiology's 67th Annual Scientific Session and published in the
Journal of the American College of Cardiology.1

The new analysis (CVD-REAL 2) assessed data from more than 400,000
patients across six countries (Australia, Canada, Israel, Japan,
Singapore and South Korea), 74% of whom did not have a history of
established cardiovascular (CV) disease. Results showed that across
this broad population of patients with T2D, treatment with an SGLT-2i
(Farxiga, empagliflozin, ipragliflozin, canagliflozin, tofogliflozin
or luseogliflozin) was associated with a 49% lower risk of ACD, 36%
of hHF, 19% of MI and 32% of stroke (p?0.001 for all) compared to
other T2D medicines. There was also a 40% lower risk of the composite
endpoint of hHF or ACD (p<0.001).1

Worldwide, diabetes affects around 425 million adults today, rising to
an estimated 629 million (1 in 10 adults) by 2045, with most of these
patients residing in Asia Pacific, the Middle East and North
America.2 People with T2D have a two-to-five times greater risk of
heart failure (HF) along with an increased risk of a heart attack or
stroke.3 Additionally, in patients with T2D, HF increases their risk
of CV death and all-cause mortality by 60-80%.4,5

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases (CVMD), Global Medicines Development, AstraZeneca, said:
"The significance and consistency of these latest results from the
ongoing CVD-REAL study are encouraging for the clinical community.
With the majority of patients in this latest analysis being treated
with Farxiga, these results suggest there is a strong association of
CV benefits with the use of Farxiga across diverse patient ethnic and
racial demographics."

The DECLARE trial (anticipated to read out in the second half of 2018)
will answer the important CV efficacy and safety questions about
Farxiga. DECLARE is the broadest and most representative CV outcomes
trial in the SGLT-2i class, and the only one with the
clinically-relevant composite of hHF/CV death as a co-primary
endpoint.6,7,8

- ENDS -

NOTES TO EDITORS

About Farxiga (dapagliflozin)

Farxiga is a first-in-class selective inhibitor of human
sodium-glucose co-transporter 2 (SGLT-2) indicated as both
monotherapy and as part of combination therapy to improve glycaemic
control, with the added benefits of blood pressure reductions and
weight loss in adult patients with T2D. Dapagliflozin is indicated as
an adjunct to diet and exercise to improve glycaemic control in
adults with T2D. Dapagliflozin is not indicated to reduce the risk of
CV events, death or hHF.

About CVD-REAL

The CVD-REAL 2 results are consistent with the primary results from
CVD-REAL
(http://circ.ahajournals.org/content/early/2017/05/16/CIRCULATIONAHA.117....).1,9
Of the patients in CVD-REAL 2, some 75% were on Farxiga, 9% on
empagliflozin, 8% on ipragliflozin (only available in South Korea and
Japan), 4% on canagliflozin, 3% on tofogliflozin and 1% on
luseogliflozin (both only available in Japan). The CVD-REAL study is
ongoing and future analyses will be conducted. The data for the study
were obtained from anonymised real-world sources including medical
records, claims databases and national registries, and were not
independently adjudicated or verified against source documents. The
meta-analyses were validated by the independent academic statistical
group at St. Luke's Mid America Heart Institute, Kansas City, US.
While CVD-REAL was a large study with a robust propensity-matching
technique, given its observational nature the possibility of
residual, unmeasured confounding factors cannot be definitively
excluded.1

About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVMD)

Cardiovascular, renal and metabolic diseases together form one of
AstraZeneca's main therapy areas and platforms for future growth. By
following the science to understand more clearly the underlying links
between the heart, kidney and pancreas, AstraZeneca is investing in a
portfolio of medicines to protect organs and improve outcomes by
slowing disease progression, reducing risks and tackling
co-morbidities. Our ambition is to modify or halt the natural course
of CVMDs and even regenerate organs and restore function, by
continuing to deliver transformative science that improves treatment
practices and CVMD health for millions of patients worldwide.

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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism
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.

Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance; Fixed Income; M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology; Other +1 240 477 3771
Christer Gruvris Brilinta; Diabetes +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
US toll free +1 866 381 7277

References

1. Kosiborod, M. Lower Risk of Cardiovascular Events and Death Associated with Initiation of SGLT-2 Inhibitors versus Other Glucose Lowering Drugs - Real World Data Across Three Major World Regions with More Than 400,000 Patients: The CVD-REAL 2 Study. Presented at the American College of Cardiology 67th Annual Scientific Session, 2018.

2. International Diabetes Federation. IDF Diabetes Atlas, 8th ed. Brussels, Belgium: International Diabetes Federation; 2017. Available at http://www.diabetesatlas.org/resources/2017-atlas.html. Accessed 21 February 2018.

3. Kannel WB, et al. Role of Diabetes in Congestive Heart Failure: The Framingham Study. American Journal of Cardiology. 1974;34:29.

4. MacDonald MR, et al. Diabetes, left ventricular systolic dysfunction, and chronic heart failure. European Heart Journal. 2008; 29:1224-1240.

5. Cubbon RM, et al. Diabetes mellitus is associated with adverse prognosis in chronic heart failure of ischaemic and non-ischaemic aetiology. Diabetes and Vascular Disease Research. 2013;10(4)330-6.

6. Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT01730534. Accessed 10 March 2018.

7. Zinman B. et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine. 2015;373:2117-28. DOI: 10.1056/NEJMoa1504720.

8. Neal B. et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. New England Journal of Medicine. 2017. DOI: 10.1056/NEJMoa1611925.

9. Kosiborod M, et al. Lower risk of heart failure and death in patients initiated on SGLT-2 inhibitors versus other glucose-lowering drugs: The CVD-REAL Study. Circulation. 2017. doi.org/10.1161/CIRCULATIONAHA.117.029190.

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