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 (https://www.escardio.org/Congresses-&-Events/ESC-Congress/Registration?gclid=Cj0KCQjwg8n5BRCdARIsALxKb97GEox27we5ETg_eOe3xo5FrBYZCaD9Y0pHPCLGc46dlHI369d1UFMaAgJKEALw_wcB).

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  (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)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 (https://www.astrazeneca.com/media-centre/press-releases/2018/farxiga-significantly-reduced-hospitalisation-for-heart-failure-or-cv-death-in-a-broad-patient-population-with-type-2-diabetes-in-the-landmark-declare-timi-58-trial.html) 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 (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) 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."

• 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, DAPA-CKD: Hot LineSunday, 30
H Dapagliflozin in August17:00 - 17:30 CEST
Patients with
Chronic Kidney
Disease
Furtado, R Efficacy and BlockbustersSaturday, 29
Safety of August8:30 - 8:36 CEST
Dapagliflozin
according to
Baseline Blood
Pressure -
Observations From
DECLARE-TIMI 58
Trial
Scholtes, R Natriuretic Effect Rapid Fire AbstractsMonday,
of 2 Weeks of 31 AugustAvailable on demand
Dapagliflozin
Treatment in
Patients with Type
2 Diabetes and
Preserved Kidney
Function: Results
of the DAPASALT
Trial
Kristensen, Dapagliflozin Rapid Fire AbstractsSaturday,
SL Reduces the Risk 29 AugustAvailable on demand
of Hyperkalaemia
in Patients with
Heart Failure and
Reduced Ejection
Fraction: A
Secondary Analysis
DAPA-HF
Dewan, P The Effect of ePosterFriday, 28
Dapagliflozin in AugustAvailable on demand
Patients with
HFrEF and COPD: A
Post-hoc Analysis
of DAPA-HF
Docherty, The Effect of ePosterFriday, 28
KF Dapagliflozin AugustAvailable on demand
Across the
Spectrum of
Baseline Risk: A
Post-hoc Analysis
of DAPA-HF
Lokelma
McEwan, P The Relationship Advances in ScienceSunday, 30
Between Duration August11:56 - 12:06 CEST
of Heart Failure,
Serum Potassium
Concentration and
Adverse Clinical
Outcomes
McEwan, P Estimating the ePosterFriday, 28
Burden of AugustAvailable on demand
Hyperkalaemia in
the UK in High
-risk Patient
Populations
McEwan, P Assessing the ePosterFriday, 28
Relationship AugustAvailable on demand
Between Serum
Potassium
Variability and
the Risk of
Hyperkalaemia and
Adverse Clinical
Outcomes
Brilinta
Bonaca, MP THEMIS-PAD Late-Breaking ScienceTuesday,
Ticagrelor in 01 September8:30 - 8:40 CEST
Patients with and
without Peripheral
Artery Disease
Willemsen, The Effect of One Late-Breaking ScienceMonday,
LM Year Postoperative 31 August9:41 - 9:50 CEST
Ticagrelor in
Addition to
Aspirin on
Saphenous Vein
Graft Patency in
Patients
Undergoing CABG -
A Randomized,
Multi-Center,
Double-Blind,
Placebo-Controlled
Trial
Steg, PG Cost-effectiveness Best ePostersMonday, 31
of Ticagrelor in AugustAvailable on demand
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
Blin, P Real World Risk of Best ePostersSunday, 30
Major Outcomes for AugustAvailable on demand
Type 2 Diabetes
with Stable
Coronary Artery
Disease Without
Prior MI or Stroke
and THEMIS-Like
Patients Using the
SNDS French
Nationwide Claims
Database
Vilahur, G Administration of Best ePostersTuesday, 01
a Soluble ADPase, SeptemberAvailable on demand
AZD3366, on Top of
Ticagrelor Confers
Additional
Cardioprotective
Benefits to that
of Ticagrelor
Alone
Parodi, G Orodispersible Best ePostersTuesday, 01
Ticagrelor Use in SeptemberAvailable on demand
Acute Coronary
Syndrome Patients:
The Ticagrelor
Administered as
Standard Tablet or
orodispersiblE
foRmulation
(TASTER) Study
Blin, P Prevalence of Type ePosterFriday, 28
2 Diabetes with AugustAvailable on demand
Stable Coronary
Artery Disease but
Without Prior
Myocardial
Infarction or
Stroke and THEMIS
-Like Patients
from the SNDS
French Nationwide
Claims Database
Early CVRM
and General
Disease
Zhang, R Lifetime Risk of BlockbustersSunday, 30
Cardiovascular August8:40 - 8:50 CEST
-Renal Disease in
Type 2 Diabetes: A
Population-Based
Study in 473399
Individuals
Elbeck, Z An Epigenetic Advances in ScienceSaturday,
Circuit Linking 29 AugustAvailable on Demand
Oxidative Stress
and DNA
Hydroxymethylation
in Heart Failure
Jonsson VENTHEART Is Best ePostersSaturday, 29
Boezelman, Required for AugustAvailable on demand
MKB Cardiomyocyte
Specification and
Function
Svedlund, S Resting Coronary ePosterFriday, 28
Blood Flow AugustAvailable on demand
Velocity Profile
Predicts Coronary
Flow Reserve in
HFpEF
 

All ESC Congress 2020 abstracts are available via the Scientific Programme & Planner (https://programme.escardio.org/ESC2020?_gl=1*1cckwyf*_gcl_aw*R0NMLjE1OTU0MTE4MDguQ2p3S0NBand4OV80QlJBSEVpd0FwQXQwenVEdHJxMFpsTU1WZ0tTRHRoOF9TaFktSjlrSW5MVGpYU3VtZE0yQ1FoNXAtRGpNU01wY0pob0NpU2NRQXZEX0J3RQ..&_ga=2.86821144.1084038435.1597049674-802287647.1595411808&_gac=1.121712249.1595411808.CjwKCAjwx9_4BRAHEiwApAt0zuDtrq0ZlMMVgKSDth8_ShY-J9kInLTjXSumdM2CQh5p-DjMSMpcJhoCiScQAvD_BwE).

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 (http://www.astrazeneca.com/) and follow the Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

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.