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2017-09-14

AstraZeneca: Bydureon EXSCEL trial demonstrates favourable CV safety profile and fewer CV events in patients with type-2 di...

Largest and most inclusive patient population of any GLP-1 CV outcomes
trial with 14,500 patients at 687 trial sites across 35 countries

Full trial results presented at the annual meeting of the European
Association for the Study of Diabetes (EASD) and simultaneously
published in the New England Journal of Medicine

AstraZeneca today announced full results from the EXSCEL (EXenatide
Study of Cardiovascular Event Lowering) trial that showed
cardiovascular (CV) safety with Bydureon (exenatide extended-release)
in patients with type-2 diabetes (T2D) at a wide range of CV risk.

Exenatide once-weekly did not increase the incidence of major adverse
cardiovascular events (MACE), a composite endpoint of CV death,
non-fatal heart attack (myocardial infarction) or non-fatal stroke,
compared to placebo (Hazard Ratio [HR]: 0.91; 95% Confidence Interval
[CI]: 0.83-1.00; p<0.001 for non-inferiority).

There were also fewer CV events observed in the exenatide arm of the
trial (839 [11.4%] versus 905 [12.2%]), although the primary efficacy
objective of a superior reduction in MACE narrowly missed statistical
significance (p=0.061). The direction of the cardiovascular outcomes
results in EXSCEL was consistent with those seen in recently
completed outcomes trials within the GLP-1 receptor agonist class.1
Additionally, in a prespecified secondary analysis, patients on
exenatide had a 14% lower incidence of death from all causes (HR:
0.86; 95% CI: 0.77-0.97).

The full results of EXSCEL, including important secondary endpoints,
sensitivity analyses and regional data, were presented at the 53rd
annual meeting of EASD and simultaneously published today online in
the New England Journal of Medicine
(http://www.nejm.org/doi/full/10.1056/NEJMoa1612917).

Investigator Rury Holman, Professor of Diabetic Medicine and Diabetes
Trials Unit Director, University of Oxford, UK, said: "People with
type-2 diabetes have up to a two-times increased risk for all-cause
mortality and four-times increased risk for cardiovascular death
compared to the general population, making it imperative that their
type-2 medication does not further increase their risk for
cardiovascular disease and related complications.2,3,4The EXSCEL
study results demonstrated that exenatide could be used safely in
patients with type-2 diabetes with a wide range of cardiovascular
risk and suggested a potential benefit with respect to all-cause
mortality."

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases, Global Medicines Development, said: "The results from the
EXSCEL trial provide important evidence supporting the use of
once-weekly Bydureon in a broad population of patients with type-2
diabetes at a wide range of cardiovascular risk. This comprehensive
trial is representative of our commitment to address multiple risk
factors or co-morbidities associated with cardiovascular and
metabolic diseases and helps to inform clinical practice for the
benefit of millions of patients with type-2 diabetes."

Multiple sensitivity analyses for MACE, recalculating the outcome
under alternative assumptions to determine the potential impact of
different variables, were consistent with primary analyses.1No safety
issues were identified during the EXSCEL trial and data were
consistent with the known safety profile of exenatide.1Specifically,
there was no imbalance in retinopathy, a microvascular complication
that commonly occurs from type-2 diabetes and can lead to serious
visual disability and blindness.

The EXSCEL trial enrolled the largest and most inclusive patient
population of any CV outcomes trial of the glucagon-like peptide-1
(GLP-1) receptor agonist class conducted to date, having included
more than 14,500 patients at 687 trial sites across 35 countries,
incorporating usual care and wide-ranging eligibility
criteria.1,5,6,7

AstraZeneca is working with regulatory authorities to incorporate
these data into the Bydureon label.

- ENDS -

NOTES TO EDITORS

About EXSCEL

EXSCEL is a Phase IIIb/IV, double-blind, placebo-controlled, global CV
outcomes trial conducted in 35 countries and enrolled 14,500 patients
with type-2 diabetes with or without additional CV risk factors or
prior CV events. Overall, 73% of included patients had experienced at
least one prior CV event, whereas 27% had not. Participants were
randomised to receive exenatide once-weekly 2mg or matching placebo
by subcutaneous injections. EXSCEL was run jointly by two academic
research organisations - the Duke Clinical Research Institute
(Durham, NC, US) and the University of Oxford Diabetes Trials Unit
(Oxford, UK).

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 main 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 products
to help more patients achieve treatment success earlier in their
disease.

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 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. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in
Type-2 Diabetes. N Engl J Med. Available at
www.nejm.org/doi/full/10.1056//NEJMoa16129. Accessed September 2017.

1. 2. Tancredi M, et al. Excess mortality among persons with type 2 diabetes. N Engl J Med. 2015;373:1720-32.
2. 3. National Centers for Disease Control and Prevention. National diabetes statistics report, 2014. Available at https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report.... Accessed August 9, 2017.
3. 4. Sarwar N, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010;375:2215-22.
4. 5. Marso SP, et al. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013;166(5):823-830.e5.
5. 6. Marso SP, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016; 375:1834-1844.
6. 7. Pfeffer MA, et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015; 373:2247-2257.

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