• SGLT2 inhibitors can play a pivotal role in improving diabetic patient care as recent scientific studies have even shown cardiovascular benefits.
  • Heart failure may arise from diverse causes, including hypertension, coronary artery disease, and contributing conditions, such as diabetes mellitus and obesity[*]
  • Urgent commitment to cardio vascular disease prevention from healthcare professionals, policy-makers, government and other stakeholders and the promotion of healthy lifestyles, is warranted[†]

The United Arab Emirates: AstraZeneca recently announced detailed results from the landmark Phase III DAPA-HF trial that showed that a common diabetes medication can be used to reduce both the incidence of cardiovascular death and the worsening of heart failure on top of standard care.

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).

Topline results announced in August 2019 showed DAPA-HF met the primary endpoint. The detailed results of the trial were presented recently at the ESC Congress 2019, which was held in Paris, France. It showed  that the  medication reduced the composite of cardiovascular (CV) death or worsening of heart failure by 26% and showed a reduction in each of the individual components of the composite endpoint.

Ismail Shehada, AstraZeneca’s Country President GCC, said: “At AstraZeneca, we are focused on delivering transformative science that improves treatment practices and cardiovascular health for patients with type 2 diabetes in the UAE and the wider region. 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.”

Dr. Hani Sabbour, Consultant Cardiologist, UAE, Clinical Assistant Professor of Cardiology (Brown University, USA)  also noted, “The complex interaction of risk factors for type 2 diabetes, makes it necessary to apply a holistic approach to the management of this chronic disorder. SGLT2 inhibitor treatments are shifting the mind-set by not only focusing on lowering blood glucose levels in patients but also offering cardio-protection by reducing the relative risk of cardiovascular death on top of standard of care in adults with type 2 diabetes and established cardiovascular disease.

In analysing each of the components of the primary composite endpoint, there was a 30% decrease  in the risk of experiencing a first episode of worsening heart failure and an 18% decrease  in the risk of dying from cardiovascular causes. The effect of the medication on the primary composite endpoint was generally consistent across the key subgroups of patients with or without type 2 diabetes.

The safety profile 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.

Over time, high blood glucose from diabetes can damage blood vessels and the nerves that control heart and blood vessels. The longer individuals have diabetes, the higher the chances that they will develop heart disease.[‡] Many Middle Eastern countries have observed increases in the prevalence of the risk factors for the development of heart failure, including diabetes, obesity, and hypertension. In the UAE, and across the region, there is a need to develop preventive programs to combat heart failure due to the increased prevalence of this disease among younger people.[§]

-ENDS-

About DAPA-HF

DAPA-HF 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 SGLT2 inhibitors, 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 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 Dapagliflozin 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.

About AstraZeneca in heart failure

AstraZeneca is committed to advancing science and clinical outcomes with Dapagliflozin 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.

References

  • Mayo Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available from URL: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
  • 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.
  • 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
  • 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
  • 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
  • Azad, N., & Lemay, G. (2014). Management of chronic heart failure in the older population. Journal of Geriatric Cardiology: JGC, 11(4), 329-37

[*] Heart Failure in the Middle East | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3682400/ 

[†] Hamdan Medical Journal | Prevalence and risk factors of cardiovascular disease in the UAE

[‡] Diabetes, Heart Disease and stroke | National Institute of Diabetes and Digestive and Kidney Diseases | https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/heart-disease-stroke 

[§] Heart Failure in the Middle East | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3682400/ 

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