Farxiga Phase III DAPA-CKD trial paradigm-shifting data to be presented at ESC 2020

Farxiga shows significant benefit across all primary and secondary endpoints in patients with chronic kidney disease with and without type-2 diabetes

Additional data from AstraZeneca’s broad portfolio reinforce the potential of its medicines to treat cardiovascular and renal diseases

AstraZeneca will present the highly anticipated detailed results from the ground-breaking Phase III DAPA-CKD trial of Farxiga in chronic kidney disease (CKD) at ESC Congress 2020 – The Digital Experience.

These results are among 20 abstracts being presented by AstraZeneca at ESC between 29 August to 1 September 2020 showcasing the breadth of its cardiovascular (CV), renal and metabolic portfolio.

In July 2020, the Company announced that the DAPA-CKD trial met all primary and secondary endpoints in patients with CKD. High-level results showed a statistically significant and clinically meaningful effect with Farxiga on the trial’s primary endpoint of a composite of worsening of renal function or risk of death in CKD patients with and without type-2 diabetes (T2D).1 The results also make Farxiga the first medicine to significantly reduce the risk of death from any cause in this patient population compared to placebo.1

DAPA-CKD is yet another landmark trial from AstraZeneca’s global DapaCare clinical programme, which is dedicated to exploring the potential of Farxiga to protect against CV and renal disease.2

The programme first shared results from the DECLARE-TIMI 58 trial, the largest CV outcomes trial conducted for an SGLT2 inhibitor to date, showing that Farxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death versus placebo.3 The Phase III DAPA-HF trial results followed DECLARE, showing that Farxiga was the first SGLT2 inhibitor to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) with and without T2D.2

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The remarkable DAPA-CKD results which will be shared at this year’s ESC Congress bring us closer to transforming the management of chronic kidney disease, a condition associated with significant patient morbidity. These data, along with the wealth of new insights being presented across our wider portfolio, show our relentless dedication to advancing science across cardiovascular, metabolic and renal diseases.”

Key highlights at ESC Congress 2020 include:

•       A pre-specified analysis of the DECLARE-TIMI 58 trial evaluating the relationship between baseline systolic blood pressure and the efficacy and safety of Farxiga on hHF and renal events in patients with T2D.4

•       New sub-analyses from DAPA-HF reviewing the effect of Farxiga across the spectrum of baseline risk in heart failure (HF) and its impact on reducing the risk of hyperkalaemia in patients with HFrEF.5,6

•       Real-world evidence [from the UK] investigating the relationship between serum potassium variability or the duration of HF and the risk of hyperkalaemia and adverse clinical outcomes (all-cause mortality and major adverse CV events).7,8

•       New sub-analyses from the THEMIS trial including an oral presentation on peripheral artery disease (PAD) outcomes, on estimating the cost-effectiveness of Brilinta in patients who had a history of percutaneous coronary intervention (PCI), plus real-world evidence for THEMIS-like patients with T2D and coronary artery disease without prior myocardial infarction or stroke.9-11

•       Early science research on an epigenetic circuit linking oxidative stress and DNA hydroxymethylation in patients with HF.11

AstraZeneca abstracts at ESC Congress 2020 – The Digital Experience:

Lead author

Abstract title

Presentation details

Farxiga

 

Heerspink, H

DAPA-CKD: Dapagliflozin in Patients with Chronic Kidney Disease

Hot Line

Sunday, 30 August

17:00 – 17:30 CEST

Furtado, R

Efficacy and Safety of Dapagliflozin according to Baseline Blood Pressure - Observations From DECLARE-TIMI 58 Trial

Blockbusters

Saturday, 29 August

8:30 – 8:36 CEST

 

Scholtes, R

Natriuretic Effect of 2 Weeks of Dapagliflozin Treatment in Patients with Type 2 Diabetes and Preserved Kidney Function: Results of the DAPASALT Trial

Rapid Fire Abstracts

Monday, 31 August

Available on demand

 

Kristensen, SL

Dapagliflozin Reduces the Risk of Hyperkalaemia in Patients with Heart Failure and Reduced Ejection Fraction: A Secondary Analysis DAPA-HF

Rapid Fire Abstracts

Saturday, 29 August

Available on demand

 

Dewan, P

The Effect of Dapagliflozin in Patients with HFrEF and COPD: A Post-hoc Analysis of DAPA-HF

ePoster

Friday, 28 August

Available on demand

Docherty, KF

The Effect of Dapagliflozin Across the Spectrum of Baseline Risk: A Post-hoc Analysis of DAPA-HF

ePoster

Friday, 28 August

Available on demand

Lokelma

 

McEwan, P

The Relationship Between Duration of Heart Failure, Serum Potassium Concentration and Adverse Clinical Outcomes

Advances in Science

Sunday, 30 August

11:56 – 12:06 CEST

 

McEwan, P

Estimating the Burden of Hyperkalaemia in the UK in High-risk Patient Populations

ePoster

Friday, 28 August

Available on demand

McEwan, P

Assessing the Relationship Between Serum Potassium Variability and the Risk of Hyperkalaemia and Adverse Clinical Outcomes

ePoster

Friday, 28 August

Available on demand

 

Brilinta

 

Bonaca, MP

THEMIS-PAD Ticagrelor in Patients with and without Peripheral Artery Disease

Late-Breaking Science

Tuesday, 01 September

8:30 – 8:40 CEST

Willemsen, LM

The Effect of One Year Postoperative Ticagrelor in Addition to Aspirin on Saphenous Vein Graft Patency in Patients Undergoing CABG – A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial

Late-Breaking Science

Monday, 31 August

9:41 – 9:50 CEST

 

Steg, PG

Cost-effectiveness of Ticagrelor in Patients with Type 2 Diabetes and Coronary Artery Disease with a History of PCI: An Economic Evaluation of THEMIS-PCI Using a Swedish Healthcare Perspective

Best ePosters

Monday, 31 August

Available on demand

 

Blin, P

Real World Risk of Major Outcomes for Type 2 Diabetes with Stable Coronary Artery Disease Without Prior MI or Stroke and THEMIS-Like Patients Using the SNDS French Nationwide Claims Database

Best ePosters

Sunday, 30 August

Available on demand

 

Vilahur, G

Administration of a Soluble ADPase, AZD3366, on Top of Ticagrelor Confers Additional Cardioprotective Benefits to that of Ticagrelor Alone

Best ePosters

Tuesday, 01 September

Available on demand

 

Parodi, G

Orodispersible Ticagrelor Use in Acute Coronary Syndrome Patients: The Ticagrelor Administered as Standard Tablet or orodispersiblE foRmulation (TASTER) Study

Best ePosters

Tuesday, 01 September

Available on demand

 

Blin, P

Prevalence of Type 2 Diabetes with Stable Coronary Artery Disease but Without Prior Myocardial Infarction or Stroke and THEMIS-Like Patients from the SNDS French Nationwide Claims Database

ePoster

Friday, 28 August

Available on demand

 

Early CVRM and General Disease

Zhang, R

Lifetime Risk of Cardiovascular-Renal Disease in Type 2 Diabetes: A Population-Based Study in 473399 Individuals

Blockbusters

Sunday, 30 August

8:40 – 8:50 CEST

Elbeck, Z

An Epigenetic Circuit Linking Oxidative Stress and DNA Hydroxymethylation in Heart Failure

Advances in Science

Saturday, 29 August

Available on Demand

 

Jonsson Boezelman, MKB

VENTHEART Is Required for Cardiomyocyte Specification and Function

Best ePosters

Saturday, 29 August

Available on demand

Svedlund, S

Resting Coronary Blood Flow Velocity Profile Predicts Coronary Flow Reserve in HFpEF

ePoster

Friday, 28 August

Available on demand


All ESC Congress 2020 abstracts are available via the
Scientific Programme & Planner.

AstraZeneca in CVRM

Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is 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 comorbidities. The Company’s 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.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) 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 & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

 

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

 

References

1.     AstraZeneca. Farxiga met all primary and secondary endpoints in groundbreaking Phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease; 2020/07/28 [cited 2020 Aug 25]. Available from: URL: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-met-all-primary-and-secondary-endpoints-in-groundbreaking-phase-iii-dapa-ckd-trial-for-the-treatment-of-patients-with-chronic-kidney-disease.html.

2.     AstraZeneca. Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure; 2019/09/01 [cited 2020 Aug 25]. Available from: URL: https://www.astrazeneca.com/media-centre/press-releases/2019/detailed-results-from-phase-iii-dapa-hf-trial-showed-farxiga-significantly-reduced-both-the-incidence-of-cardiovascular-death-and-the-worsening-of-heart-failure-01092019.html.

3.     Wiviott SD et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2019; 380(4):347–57.

4.     Furtado R et al. Efficacy and safety of dapagliflozin according to baseline blood pressure - Observations from DECLARE-TIMI 58 Trial. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

5.     Docherty KF et al. The effect of dapagliflozin across the spectrum of baseline risk: a post-hoc analysis of DAPA-HF. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

6.     Kristensen S et al. Dapagliflozin reduces the risk of hyperkalaemia in patients with heart failure and reduced ejection fraction: a secondary analysis DAPA-HF. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

7.     McEwan P et al. The relationship between duration of heart failure, serum potassium concentration and adverse clinical outcomes. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

8.     McEwan P et al. Assessing the relationship between serum potassium variability and the risk of hyperkalaemia and adverse clinical outcomes. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

9.     Bonaca M et al. THEMIS-PAD Ticagrelor in Patients with and without Peripheral Artery Disease. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

10.  Steg PG et al. Cost-effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease with a history of PCI: an economic evaluation of THEMIS-PCI using a Swedish healthcare perspective. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

11.  Blin P et al. Prevalence of type 2 diabetes with stable coronary artery disease but without prior myocardial infarction or stroke and THEMIS-like patients from the SNDS French nationwide claims database. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

12.  Elbeck Z et al. An epigenetic circuit linking oxidative stress and DNA hydroxymethylation in heart failure. Presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 1.

 

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  • Hjärta Kärl