A landmark study involving patients from 33 countries, including the Philippines, shows that the AstraZeneca drug, Dapagliflozin, significantly reduces the risk of hospitalization and death in a broad range of patients with type 2 diabetes, as well as helps protect heart and kidney.
AstraZeneca presented the positive full results from the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 cardiovascular (CV) outcomes trial for Dapagliflozin on Nov. 10 at the American Heart Association Scientific Sessions 2018 in Chicago, USA, and simultaneously published in the New England Journal of Medicine.
The DECLARE-TIMI 58 is the largest SGLT2 inhibitor CVOT conducted to date, including more than 17,000 patients across 33 countries, including the Philippines where 337 Filipino patients were enrolled. In 2017, there were over 3,721,900 Filipinos with diabetes in the Philippines, according to the International Diabetes Federation.
The trial showed the prescription medicine significantly reduces the risk of hospitalization for heart failure (hHF) or CV death composite vs. placebo by 17 percent. The reduction in heart failure or cardiovascular death was consistent across the entire patient population, which included those with CV risk factors and those with established CV disease.
Additionally, there were fewer major adverse cardiovascular events (MACE) observed with Dapagliflozin for the other primary efficacy endpoint; however, this did not reach statistical significance.
DECLARE-TIMI 58 also confirms 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, fractures, bladder cancer or Fournier’s gangrene. The respective incidences of diabetic ketoacidosis and genital infections were rare.
Dr. Araceli Panelo, chairman of the Board of Trustees of the Institute for Studies on Diabetes Foundation said, “This is a groundbreaking development for T2D patients as DECLARE gives us hope that we may be able to prevent or delay the onset of heart failure in a broad patient population.”
Dr. Rosa Allyn Sy, lead Philippine DECLARE investigator for Endocrinology, and section head for Endocrinology, Diabetes, Metabolism and Nutrition of Cardinal Santos Medical Center and Ospital ng Makati said, “In achieving statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death, the DECLARE study results mark an important milestone for T2D patients and its management.”