AstraZeneca announces results from Phase III DECLARE cardiovascular outcomes trial
Source: FleishmanHillard for AstraZeneca , Author: Posted by BI-ME staff
Posted: Mon October 8, 2018 3:10 pm

UAE. AstraZeneca, one of the world’s leading pharmaceutical companies announced recently results from the Phase III DECLARE cardiovascular outcomes trial. The study, which included more than 17,000 patients across 882 sites in 33 countries, focused CV outcomes in adults with type 2 diabetes.


- Currently, the prevalence of type 2 diabetes in the Middle East is estimated at 9.7%. The region has the highest prevalence of diabetes in the world [1]
- Cardiovascular disease (CVD) is the number one cause of death among people with type 2 diabetes, accounting for 52% of deaths in type 2 diabetes worldwide[2]

The DECLARE trial successfully met the primary safety endpoint of non-inferiority for major adverse cardiovascular events across this broad patient population.

One of the earliest, most common, and most serious cardiovascular disorders in patients with diabetes is heart failure. Many sudden deaths in diabetes are related to underlying ventricular dysfunction rather than a new ischemic event [3].

The National Agenda of UAE 2021 emphasizes the importance of preventive medicine and seeks to reduce lifestyle related diseases such as diabetes and cardiovascular diseases to ensure a longer and healthier life for citizens.

Dr. Anamarija Gjurovic, Medical Director Gulf States, at AstraZeneca said: “Heart failure is a frequent complication of diabetes that occurs relatively early throughout the disease progression. These results make DECLARE a landmark trial in a patient population with type-2 diabetes and cardiovascular risk, where a significant unmet need remains amongst the estimated 425 million people living with diabetes globally.”

“AstraZeneca shares a commitment with health authorities in the region to support patients in fulfilling those needs and in achieving an optimal treatment strategy for better healthcare management,” added Dr. Gjurovic.

Moreover, Dr. Abdul Razzak Al Madani, President of Emirates Diabetes Society also noted, “The DECLARE-TIMI 58 top line results offer compelling evidence that SGLT2 inhibitors help address an important medical need among a diverse group of patients with type-2 diabetes by reducing the composite of hospitalisation for heart failure or CV death. SGLT2 inhibitors can play a pivotal role in improving patient care as recent scientific studies have even showed positive cardiovascular effects[4]. 

The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalisations that result in a considerable societal and economic burden.

The relationship between diabetes and CVD is complex; diabetes is a risk factor for CVD and conditions such as high blood pressure and obesity, that are more common in people with diabetes, are also risk factors for CV disease[5]. Reducing cardiovascular risk is an essential component of diabetes management and so patients need to be better educated on how to modify cardiovascular risk factors in order to offer the best chance of improving CVD outcomes.

Dr. Abdullah Shehab, President of Emirates Cardiac Society added, “DECLARE’s top line results have yet again strongly supported the CV benefits of SGLT2 inhibitors in a much broader type-2 diabetes population. Knowing that heart failure is one of the early cardiovascular complications for these patients, it also points to a shift towards an early treatment paradigm in a diabetic patient group that is highly relevant to our everyday cardiology practice.”

Signs and symptoms of type 2 diabetes often develop slowly. Patients need to look out for common symptoms that include increased thirst and frequent urination, increased hunger, weight loss, fatigue, blurred vision, slow-healing sores or frequent infections, as well as areas of darkened skin [6]. Type 2 Diabetes has a major public health impact due to rapid economic growth, sedentary lifestyles and unhealthy diets which are all characteristic to the UAE[7].

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)
Cardiovascular, renal and metabolism together forms one of AstraZeneca’s main therapy areas and key growth drivers. 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.

Our 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, Cardiovascular, Renal & Metabolism and Respiratory. 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. Media Relations

AstraZeneca in the Gulf
As one of the leading pharmaceutical companies in the Gulf, AstraZeneca is focused on developing innovative medicines to treat diseases in important therapy areas impacting public health. Their success is based on our commitment to serving the needs of the patients and improving their health.

AstraZeneca believes in maintaining high ethical standards of business practice. Aiming to effectively manage that responsibility, they find new ways of bringing benefit to society and thereby ensure that AstraZeneca continues to be welcomed as a valued member of the local community.

References

[1]  Type 2 diabetes in the Middle East and North Africa (MENA) | https://www.researchgate.net/publication/310737674
[2]  Mortality and cause of death in the WHO Multinational Study of Vascular Disease in Diabetes | https://www.researchgate.net/publication/11762754
[3]  American Diabetes Association | Heart Failure: The Most Important, Preventable, and Treatable Cardiovascular Complication of Type 2 Diabetes  | http://care.diabetesjournals.org/content/41/1/11
[4]  SGLT2 Inhibitors: Are they safe? https://www.ncbi.nlm.nih.gov/pubmed/29039237
[5]  Diabetes as a risk factor for cardiovascular disease. Available from:
https://www.world-heart-federation.org/resources/risk-factors/ 
[6]  Mayo Clinic| https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/symptoms-causes/syc-20351193
[7]  http://www.icldc.ae/about-us/p/UAE-Diabetes-Trends-And-Numbers

 

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