TIDMAZN
RNS Number : 8027K
AstraZeneca PLC
02 September 2019
02 September 2019 07:00 BST
Detailed results from Phase III DAPA-HF trial showed Farxiga
significantly reduced both the incidence of cardiovascular
death
and the worsening of heart failure
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor in
patients with
heart failure with reduced ejection fraction, with and without
type-2 diabetes
AstraZeneca today announced detailed results from the landmark
Phase III DAPA-HF trial that showed Farxiga (dapagliflozin) on top
of standard of care reduced both the incidence of cardiovascular
death and the worsening of heart failure.
DAPA-HF is the first outcomes trial with an SGLT2 inhibitor
investigating the treatment of heart failure in patients with
reduced ejection fraction (HFrEF), with and without type-2 diabetes
(T2D). Farxiga is currently approved to treat patients with
T2D.
Topline results announced in August 2019 showed DAPA-HF met the
primary endpoint. The detailed results of the trial presented at
the ESC Congress 2019 in Paris, France, showed Farxiga reduced the
composite of cardiovascular (CV) death or worsening of heart
failure by 26% (p<0.0001) and showed a reduction in each of the
individual components of the composite endpoint.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Farxiga is well established in the treatment of
type-2 diabetes, and these exciting new findings offer clinically
meaningful insights into the potential of the medicine to reduce
the burden of heart failure in patients with and without type-2
diabetes. We are proud to be contributing to the scientific body of
evidence during the ESC Congress 2019."
John McMurray, MD, University of Glasgow, Cardiovascular
Research Centre, Institute of Cardiovascular and Medical Sciences,
said: "We are very pleased that Farxiga was so effective in our
trial - it did all the things we would like any drug to do in heart
failure, which are to improve symptoms, reduce hospital admissions
and increase survival. Even better, Farxiga was as effective in
heart failure patients without diabetes as in those with
diabetes."
In analysing each of the components of the primary composite
endpoint, there was a 30% decrease (p<0.0001) in the risk of
experiencing a first episode of worsening heart failure and an 18%
decrease (p=0.0294) in the risk of dying from cardiovascular
causes. The effect of Farxiga on the primary composite endpoint was
generally consistent across the key subgroups examined.
The trial results also showed a significant improvement in
patient reported outcomes measured by the Kansas City
Cardiomyopathy Questionnaire (KCCQ) total symptom score and a
nominally significant reduction in all-cause mortality by 17% (7.9
versus 9.5 patients with an event per 100 patient-years) in favour
of Farxiga.
The safety profile of Farxiga in the DAPA-HF trial was
consistent with the well-established safety profile of the
medicine. The proportion of patients with volume depletion (7.5%
versus 6.8%) and renal adverse events (6.5% vs 7.2%), which are
commonly of concern when treating heart failure, were comparable to
placebo. Major hypoglycaemic events (0.2% versus 0.2%) were rare in
both treatment groups.
Farxiga is also being studied in patients with heart failure
with preserved ejection fraction (HFpEF) in the DELIVER and
DETERMINE (HFrEF and HFpEF) trials.
About DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in
Heart Failure) is an international, multi-centre, parallel group,
randomised, double-blinded trial in patients with heart failure and
reduced ejection fraction (LVEF <= 40%), with and without T2D,
designed to evaluate the effect of Farxiga 10mg, compared with
placebo, given once daily in addition to standard of care. The
primary composite outcome was time to a worsening heart failure
event (hospitalisation or equivalent event; i.e. an urgent heart
failure visit), or cardiovascular death.
About heart failure
Heart failure (HF) is a life-threatening disease in which the
heart cannot pump enough blood around the body.(1) It affects
approximately 64 million people worldwide (half of which have a
reduced ejection fraction) and is a chronic and degenerative
disease where half of patients will die within five years of
diagnosis.(2,3,4) HF remains as 'malignant' as some of the most
common cancers in both men (prostate and bladder cancers) and women
(breast cancers).(5) It is the leading cause of hospitalisation for
those over the age of 65 and represents a significant clinical and
economic burden.(6)
About Farxiga
Farxiga is a first-in-class, oral once-daily SGLT2 inhibitor
indicated as both monotherapy and as part of combination therapy to
improve glycaemic control, with the additional benefits of weight
loss and blood-pressure reduction, as an adjunct to diet and
exercise in adults with T2D. Farxiga has a robust programme of
clinical trials that includes more than 35 completed and ongoing
Phase IIb/III trials in more than 35,000 patients, as well as more
than 2.5 million patient-years' experience.
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 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 Farxiga in people with and
without T2D. 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 patients with established CV disease, CV
risk factors and varying stages of renal disease, both with and
without T2D, providing healthcare providers with evidence needed to
improve patient outcomes.
Farxiga is also being developed for patients with heart failure
in the DELIVER (HFpEF) and DETERMINE (HFrEF and HFpEF) trials, in
addition to chronic kidney disease in the DAPA-CKD trial. DapaCare
underscores our commitment to following the science by pursuing a
holistic patient approach to address the multiple risk factors
associated with CV, renal and metabolic diseases.
About AstraZeneca in heart failure
AstraZeneca is committed to advancing science and clinical
outcomes with Farxiga in the treatment of people with HF. The
company's extensive clinical programme includes several global
Phase III trials (DAPA-HF, DELIVER and DETERMINE) focusing on
distinct and clinically important areas of HF research in order to
provide comprehensive clinical evidence around the disease and
address areas of high unmet need in HF. AstraZeneca is also
investing its efforts in compelling new science through early-stage
research of several potential medicines to address HF.
About AstraZeneca in CVRM
Cardiovascular, Renal & 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 co-morbidities. 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.
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 therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and follow us on Twitter
@AstraZeneca.
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AstraZeneca PLC
References
1. Mayo Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available from URL: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
2. Vos T et al. Global, regional, and national incidence,
prevalence, and years lived with disability for 328 diseases and
injuries for 195 countries, 1990-2016: A systematic analysis for
the Global Burden of Disease Study 2016. The Lancet 2017;
390(10100):1211-59.
3. Mozaffarian D et al. Circulation. 2016 Jan 26;133(4):e38-360 and the CDC: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm
4. Bhuiyan, Taslima, and Mathew S Maurer. "Heart Failure with
Preserved Ejection Fraction: Persistent Diagnosis, Therapeutic
Enigma." Current cardiovascular risk reports vol. 5,5 (2011):
440-449. doi:10.1007/s12170-011-0184-2
5. Mamas, M. A., Sperrin, M., Watson, M. C., Coutts, A., Wilde,
K., Burton, C., ... Myint, P. K. (2017). Do patients have worse
outcomes in heart failure than in cancer? A primary care-based
cohort study with 10-year follow-up in Scotland. European Journal
of Heart Failure, 19(9), 1095-1104.
https://doi.org/10.1002/ejhf.822
6. Azad, N., & Lemay, G. (2014). Management of chronic heart
failure in the older population. Journal of Geriatric Cardiology:
JGC, 11(4), 329-37.
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