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2019-03-18

AstraZeneca: First sub-analyses from the DECLARE-TIMI 58 trial further support the cardiovascular effects of Farxiga in typ...

Farxiga reduced major adverse cardiovascular events by 16% in patients
who had a prior heart attack

Farxiga reduced hospitalisation for heart failure regardless of
ejection fraction status

Positive results from a pre-specified sub-analysis of the Phase III
DECLARE-TIMI 58 trial showed that Farxiga (dapagliflozin) reduced the
relative risk of major adverse cardiovascular events (MACE) by 16%
compared to placebo in patients with type-2 diabetes (T2D) who had a
prior heart attack (myocardial infarction).

In another pre-specified sub-analysis, Farxiga compared to placebo
reduced the relative risk of hospitalisation for heart failure (hHF)
in patients with T2D regardless of their ejection fraction (EF)
status, a measurement of the percentage of blood leaving the heart
with each contraction.

The data were presented today at the American College of Cardiology's
(ACC) 68th Annual Scientific Session, New Orleans, USA and were
published in Circulation.1,2

Elisabeth Björk, Senior Vice President, Head of late Cardiovascular,
Renal and Metabolism, R&D BioPharmaceuticals, said: "These data build
upon the existing evidence of the cardio-renal effects of Farxiga,
with important new evidence on heart failure and MACE. Heart failure
is one of the most common early cardiovascular complications of
type-2 diabetes. Despite advances in healthcare, it remains as
life-threatening and prevalent as the combined incidence of the
top-four most common forms of cancer. Therefore, more needs to be
done for patients."

Dr. Stephen Wiviott of Brigham and Women's Hospital and Harvard
Medical School, a senior investigator with the Thrombolysis in
Myocardial Infarction (TIMI) study group and co-principal
investigator of the trial, said: "Data from these pre-specified
sub-analyses offer important and clinically-relevant insights for
cardiologists and their patients. We now have new evidence from
DECLARE-TIMI 58 that shows Farxiga consistently reduced
hospitalisation for heart failure across a broad range of patients
with type-2 diabetes, regardless of their history of existing CV
disease, including heart attack, or heart failure."

These pre-specified sub-analyses of DECLARE-TIMI 58
(https://www.astrazeneca.com/media-centre/press-releases/2018/farxiga-sig...)
add to the positive primary results of the trial presented in
November 2018, which showed that Farxiga significantly reduced the
risk of the composite of hHF or CV death compared to placebo,
consistently across the trial's entire patient population.
Additionally, there were fewer major adverse cardiovascular events
observed with Farxiga in the broad patient population, however this
did not reach statistical significance.

Farxiga is a selective inhibitor of human sodium-glucose
co-transporter 2 (SGLT2 inhibitor) indicated as monotherapy and as
part of combination therapy to improve glycaemic control in adult
patients with T2D. Farxiga is not indicated to reduce the risk of CV
events, heart failure or death.

- ENDS -

NOTES TO EDITORS

About DECLARE-TIMI 58

DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an
AstraZeneca-sponsored, randomised, double-blinded,
placebo-controlled, multicentre trial designed to evaluate the effect
of Farxiga compared with placebo on CV outcomes in adults with T2D at
risk of CV events, including patients with multiple CV risk factors
or established CV disease. DECLARE included more than 17,000 patients
across 882 sites in 33 countries and was independently run in
collaboration with academic investigators from the TIMI study group
(Boston, USA) and the Hadassah Hebrew University Medical Center
(Jerusalem, Israel).

About DapaCare

DECLARE is part of the extensive DapaCare clinical programme for
Farxiga, which will enrol patients in randomised clinical trials
including a wide range of mechanistic trials and is supported by a
multinational real-world evidence study (CVD-REAL). The DapaCare
clinical programme will generate data across a spectrum of people
with CV risk factors, established CV disease and varying stages of
renal disease, both with and without T2D. DECLARE is paving the way
for three Phase III trials: Dapa-HF, DELIVER and Dapa-CKD. Farxiga is
not indicated to reduce the risk of CV events, CV death, or hHF, or
the treatment of CKD.

About Farxiga

Farxiga (dapagliflozin) is a first-in-class, oral once-daily selective
inhibitor of human sodium-glucose co-transporter 2 (SGLT2) indicated
as both monotherapy and as part of combination therapy to improve
glycaemic control, with the additional benefits of weight loss and
blood pressure reduction, as an adjunct to diet and exercise in
adults with T2D. Farxiga has a robust clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials in over
35,000 patients, as well as more than 1.8 million patient-years'
experience.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and a key growth driver for the
Company. By following the science to understand more clearly the
underlying links between the heart, kidneys 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 CVRM diseases and potentially regenerate organs and
restore function, by continuing to deliver transformative science
that improves treatment practices and cardiovascular 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. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide. For
more information, please visit astrazeneca.com
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

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References

1. Kato ET, Silverman MG, Mosenzon O, et al. Effect of dapagliflozin on heart failure and mortality in type 2 diabetes mellitus. Circulation.

2. Furtado RHM, Bonaca MP, Raz I, et al. Dapagliflozin and cardiovascular outcomes in patients with type 2 diabetes and prior myocardial infarction - a sub-analysis from DECLARE TIMI-58 trial. Circulation.

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