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2017-06-12

AstraZeneca: AstraZeneca presents new data underpinning safety profile and Real-World CV outcomes of Farxiga at ADA 2017

Comprehensive updated analysis provides valuable evidence on the
safety profile of Farxiga, including no imbalance in lower-limb
amputations

New analyses from CVD-REAL examine reductions in CV events for SGLT-2
inhibitors, including Farxiga in patients with and without CV disease
versus DPP-4 inhibitors

AstraZeneca presented new data at the American Diabetes Association's
(ADA) 77th Scientific Sessions underpinning the safety profile of
Farxiga (dapagliflozin) with an analysis of data pooled from
dapagliflozin clinical trials1, as well as three new cardiovascular
(CV) outcomes analyses from the ongoing CVD-REAL study, the first
large real-world evidence study of its kind evaluating treatment with
SGLT-2 inhibitors (SGLT-2i), including dapagliflozin.2-4

In an updated safety analysis, data pooled from 30 Phase IIb/III
clinical trials for dapagliflozin showed no new safety signals and
the incidence of adverse events was generally similar to that in the
control groups. Importantly, there was no imbalance in lower-limb
amputations, with eight (0.1%) patients and seven (0.2%) patients
identified in the dapagliflozin and control groups, respectively.[i]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

Following the primary publication of the CVD-REAL study in May 2017,
three new analyses presented at ADA add to the ongoing evaluation of
earlier treatment with SGLT-2is and in broader patient populations
with type-2 diabetes (T2D). The analyses evaluated effects in
additional real-world patient populations, including CV endpoints
specific to dapagliflozin:

·
A two-country analysis of more than 30,000 patients with T2D showed a
significant reduction in the rates of hospitalisation for kidney
disease by 62% (p<0.001), hospitalisation for heart failure (HF) by
37% (p<0.001) and death from any cause by 27% (p=0.003) for patients
using dapagliflozin versus DPP-4 inhibitors (DPP-4is)[ii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

·
A three-country analysis of nearly 100,000 patients with T2D showed a
significant reduction in rates of CV death by 47% (p<0.001) and
hospitalisation for HF by 30% (p<0.001), for patients new to SGLT-2is
versus other T2D medicines[iii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

·
A late-breaking oral presentation analysing data from more than
300,000 patients across five countries will explore the rates of HF
and death in patients with T2D, both with and without CV disease,
receiving treatment with SGLT-2is versus other T2D medicines (Oral
377-OR, Tuesday June 13, 10:45am PDT)[iv]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases, Global Medicines Development, said: "SGLT-2 inhibitors are
being prescribed with greater frequency for patients with type-2
diabetes, so it is vital that we have a clear understanding of the
safety profile of these medicines and examine their effectiveness in
a real-world setting. The data we are presenting at ADA underpins the
safety of Farxiga and highlights the potential for earlier use of the
SGLT-2 inhibitor class, and in broader patient populations than
originally understood."

The CVD-REAL study is ongoing and future analyses will be conducted
using this dataset as well as data from additional countries. 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 analysis was validated by the independent academic
statistical group at St. Luke's Mid America Heart Institute, Kansas
City, USA. 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.

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 hospitalisation
for heart failure. The dapagliflozin cardiovascular outcomes trial,
DECLARE, is ongoing and expected to provide data in 2019 at the
latest.

- ENDS -

NOTES TO EDITORS

About the DapaCare Clinical Programme

AstraZeneca is taking a holistic, patient-centric approach to disease
management by addressing the underlying morbidity, mortality and
organ damage associated with cardiovascular (CV), metabolic and renal
diseases. Due to the interconnectivity of these diseases, AstraZeneca
has developed the DapaCare clinical programme to explore the CV and
renal profile of dapagliflozin in people with and without type-2
diabetes. The clinical programme will enrol nearly 30,000 patients in
randomised clinical trials and is supported by a multinational
real-world evidence study. DapaCare will generate data across a
spectrum of people with established CV disease, CV risk factors and
varying stages of renal disease, both with and without type-2
diabetes, providing healthcare providers with evidence needed to
improve patient outcomes. DapaCare underscores our commitment to
following the science by pursuing a holistic patient approach to
address the multiple risk factors associated with CV, metabolic and
renal diseases.

About AstraZeneca in Cardiovascular & Metabolic Diseases (CVMD)

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.

Media Relations
Esra Erkal-Paler UK/Global +44 7771 740311
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
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Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
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US toll free +1 866 381 7277

----------------------------------------------------------------------

[i]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Jabbour, S. et al. "Safety Update on Dapagliflozin (DAPA) Across the
Phase 2b/3 Clinical Trial Program." American Diabetes Association
Scientific Sessions 2017. Abstract #1263-P

[ii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Norhammar A. et al. "Dapagliflozin is associated with lower risk of
hospitalisation for kidney disease, heart failure and all-cause death
compared to DPP-4i: CVD-REAL Nordic." American Diabetes Association
Scientific Sessions 2017. Abstract #165-LB

[iii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Birkeland K. et al. "SGLT-2i is associated with lower risk of
mortality and heart failure compared to other glucose lowering drugs:
A three-country analysis." American Diabetes Association Scientific
Sessions 2017. Abstract #1205-P

[iv]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Cavender M. et al. "Hospitalisation for heart failure and death in
new users of SGLT-2 inhibitors in patients with and without
cardiovascular disease - CVD-REAL study." American Diabetes
Association Scientific Sessions 2017. Abstract #377-OR

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