AstraZeneca to present scientific advances in cardiovascular and metabolic diseases at 2017 ADA Scientific Sessions

Updated safety data on risk-benefit profile of Farxiga (dapagliflozin), three new analyses from the landmark CVD-REAL study, including Farxiga vs DPP-4 inhibitors, and a late-breaking oral presentation reveal further CV evidence across a broad population of patients with type-2 diabetes

Data from DURATION-7 and DURATION-8 evaluating efficacy and safety of Bydureon (exenatide extended-release) in combination with basal insulin and Farxiga, respectively

More than 50 abstracts demonstrate commitment to Cardiovascular and Metabolic Diseases

8 June 2017

AstraZeneca and its global biologics research and development arm, MedImmune, will present the latest research from the Company’s Cardiovascular and Metabolic Diseases (CVMD) therapy area, including for Farxiga (dapagliflozin) and Bydureon (exenatide extended-release), with more than 50 abstracts at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego, USA, 9-13 June 2017.

Ludovic Helfgott, Vice President, CVMD, said: “Science points to the need to move beyond lowering blood sugar to treat patients with type-2 diabetes holistically and earlier in their disease progression. Through investment in rigorous clinical and real-world evidence studies in large and diverse patient populations, we are committed to advancing scientific understanding of the connections between these highly-prevalent cardiovascular and metabolic diseases and helping to enhance clinical practice to improve the lives of patients.”

Highlights include a comprehensive updated safety analysis of dapagliflozin and three additional analyses from the landmark CVD-REAL real-world evidence study, including CV data for dapagliflozin, evaluating the risk of hospitalisation for kidney disease and heart failure (HF), as well as all-cause mortality, compared to DPP-4 inhibitors, a commonly-used treatment for type-2 diabetes (T2D). Additionally, a late-breaking oral presentation will explore the rates of HF and death in patients with T2D, both with and without cardiovascular disease, receiving treatment with SGLT-2 inhibitors (SGLT-2i) versus other T2D medicines.

Also presented will be the baseline characteristics and trial design of DECLARE, the largest cardiovascular outcomes trial in the SGLT-2i class. Both CVD-REAL and DECLARE are part of the extensive DapaCare programme for dapagliflozin, which involves patients with and without T2D to generate data across established CV disease, CV risk factors and varying stages of renal disease, providing healthcare providers with evidence needed to improve patient care.

AstraZeneca will also present analyses from DURATION-8, evaluating the investigational use of exenatide extended-release in combination with dapagliflozin, as well as primary data from DURATION-7, examining exenatide extended-release in combination with basal insulin.

Notable data being presented by AstraZeneca include:

Real-World Evidence on Evaluating CV Outcomes Treatment with SGLT2 inhibitors

• Evaluation of SGLT2i on Risk of Mortality and Heart Failure Compared to Other Glucose Lowering Drugs: A Three-country Analysis (Poster 1205-P, Sunday June 11, 12:00 p.m. PDT)^[1]
• Hospitalisation for Heart Failure and Death in New Users of SGLT2 Inhibitors in patients With and Without Cardiovascular Disease – CVD-REAL Study (Oral 377-OR, Tuesday June 13, 10:45 a.m. PDT)^[2]
• Evaluation of dapagliflozin on Risk of Hospitalization for Kidney Disease, Heart Failure and All-Cause Death Compared to DPP-4i: CVD-REAL Nordic (Late-Breaker 165-LB, Sunday June 11, 12:00 p.m. PDT)^[3]

Comprehensive New Safety Analysis of Dapagliflozin

• Safety Update on dapagliflozin (DAPA) Across the Phase 2b/3 Clinical Trial Program (Poster 1263-P, Sunday June 11, 12:00 p.m. PDT)^[4]

DECLARE Trial Design and Baseline Characteristics

• DECLARE-TIMI 58: Design and Baseline Characteristics (Poster 1245-P, Sunday June 11, 12:00 p.m. PDT)^[5]

Data Assessing GLP-1 receptor agonists with Other Antidiabetic Agents

• Efficacy and Safety of exenatide QW Versus Placebo Added to Insulin Glargine in Uncontrolled Basal-Insulin Treated type-2 Diabetes: DURATION-7 Trial (Oral 132-OR, Saturday June 10, 4:45 p.m. PDT)^[6]
• DURATION-8 Randomized Controlled Trial 1-Year Results: Efficacy and Safety of Once-Weekly Exenatide (ExQW) Plus Once-Daily Dapagliflozin (DAPA) Versus ExQW or DAPA Alone (Late-Breaker Poster 141-LB, Sunday June 11, 12:00 p.m. PDT)
• Effects of exenatide Once Weekly Plus dapagliflozin, exenatide Once Weekly, or dapagliflozin Added to metformin Monotherapy on Cardiovascular Risk Markers in Patients with type-2 diabetes in the DURATION-8 trial (Poster 1152-P, Sunday June 11, 12:00 p.m. PDT)^[7]
• DURATION-8: Mechanisms of Glycemic Control for exenatide Plus dapagliflozin Versus Each Drug Alone (Poster 1074-P, Sunday June 11, 12:00 p.m. PDT)^[8]
• Exenatide Once Weekly (QW) Plus dapagliflozin, exenatide QW, or dapagliflozin Added to metformin Monotherapy in Subgroups of Patients with type-2 Diabetes in the DURATION-8 Study (Poster 1115-P, Sunday June 11, 12:00 p.m. PDT)^[9]

The full list of AstraZeneca scientific presentations can be accessed on the ADA website here.

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.

CONTACTS

References

[1] 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

[2] Cavender M. et al. “Hospitalization 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

[3] Norhammar A. et al. “Dapagliflozin is associated with lower risk of hospitalization 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

[4] 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

[5] Raz I. et al. “DECLARE-TIMI 58: Design and Baseline Characteristics.” American Diabetes Association Scientific Sessions 2017. Abstract #1245-P

[6] Frias J. et al. “Efficacy and safety of exenatide QW versus placebo added to insulin glargine in uncontrolled basal-insulin treated type 2 diabetes: DURATION-7 trial.” American Diabetes Association Scientific Sessions 2017. Abstract #132-OR

[7] Jabbour S. et al. “Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly, or dapagliflozin added to metformin monotherapy on cardiovascular risk markers in patients with type 2 diabetes in the DURATION-8 study.” American Diabetes Association Scientific Session 2017. Abstract #1152-P

[8] Ferrannini E. et al. “DURATION-8: Mechanisms of glycemic control for exenatide plus dapagliflozin versus each drug alone.” American Diabetes Association Scientific Sessions 2017. Abstract #1074-P

[9] Frias J. et al. “Exenatide once weekly (QW) plus dapagliflozin, exenatide QW, or dapagliflozin added to metformin monotherapy in subgroups of patients with type 2 diabetes in the DURATION-8 study.” American Diabetes Association Scientific Sessions 2017. Abstract #1115-P