AstraZeneca, one of the world’s leading pharmaceutical companies, recently announced the results of its DECLARE-TIMI 58 cardiovascular outcomes trial, the largest SGLT2 inhibitor study conducted to date, The data were presented as a late-breaking abstract (#19485) at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, Illinois, USA, and simultaneously published in the New England Journal of Medicine.6
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.
The DECLARE-TIMI 58 top line results offer compelling evidence that Dapagliflozin, helps address an important medical need among a diverse group of patients with type-2 diabetes. The study, which included more than 17,000 patients across 33 countries, showed that Dapagliflozin significantly reduced the composite endpoint of risk of hospitalisation for heart failure & cardiovascular death vs. placebo by 17%.
DECLARE-TIMI 58 also confirmed the well-established safety profile for Dapagliflozin, which met the primary safety endpoint of non-inferiority vs. placebo, demonstrating no increase in the composite of MACE, defined as CV death, heart attack (myocardial infarction), or stroke.
Further, on other relevant safety measures, the trial showed no imbalance with Dapagliflozin vs. placebo in amputations (1.4% vs. 1.3%), fractures (5.3% vs. 5.1%), bladder cancer (0.3% vs. 0.5%) or Fournier’s gangrene (1 case vs. 5 cases). The respective incidences of diabetic ketoacidosis (0.3% vs. 0.1%) and genital infections (0.9% vs. 0.1%) were rare.
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. SGLT2 inhibitors can play a pivotal role in improving patient care as recent scientific studies have even showed positive cardiovascular effects .
The prevalence of type 2 diabetes in the United Arab Emirates is amongst the highest in the world. In a recent study done by the ministry of health the prevalence of diabetes in adult population (20-79 years) diabetes has reduced to 11.8% in comparison to the previous estimates of 19.8% seen in the previous years.
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. AstraZeneca shares this objective with the UAE government and will sustain all efforts to support the diabetes management of patients.
Dr. Abdulrazzaq Madani, president of the Emirates Diabetes Society said, “Diabetes in the region is a soaring epidemic. The increased prevalence of type 2 diabetes in the Middle East has made it a key priority to the government’s health agenda. Healthy lifestyle, healthy eating and regular physical activity and weight management are key in preventing diabetes.
On this World diabetes day, I want to reiterate on the importance of awareness campaigns and encourage our patients to control their blood sugars better so as to prevent diabetic complications and better manage the disease.”
Dr. Madani further added “With the advent of new oral therapies available for treatment of type 2 diabetes and review of the clinical data, favourable cardiovascular and renal outcomes have been seen, which offer better options to patients and to physicians for treatment of type 2 diabetes.”
Dr Anamarija Gjurovic, medical director, Gulf, AstraZeneca’s commented “DECLARE confirmed the well-established safety profile of dapagliflozin in this landmark trial of over 17,000 patients for 4.2 years, in a population representative of the everyday T2D patients, these positive results are clinically relevant to the 425 million people worldwide living with type 2 diabetes, who have a two-to-five times greater risk of heart failure along with an increased risk of a heart attack or stroke. Heart failure survival rates are only 50% after five years from diagnosis, which is why these new findings are so important in broadening our understanding of how to go beyond blood glucose control, so we may better address this serious and often overlooked cardiovascular complication.
This is another demonstration of AstraZeneca’s scientific leadership in cardiovascular, renal and metabolic (CVRM) diseases and we are tremendously excited about what this trial means for patients.
