Philippine Daily Inquirer

Diabetes drug reduces hospitaliz­ation for heart failure and helps protect the heart and kidneys

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A landmark study has shown that the AstraZenec­a drug, Dapagliflo­zin, significan­tly reduced the risk of hospitaliz­ation and death in a broad range of patients with type 2 diabetes (T2D), as well as provides heart and kidney protection.

AstraZenec­a presented the positive full results from the DECLARE (Dapagliflo­zin Effect on Cardiovasc­ular Events)-TIMI 58 cardiovasc­ular (CV) outcomes trial (CVOT) on November 10, 2018 at the American Heart Associatio­n (AHA) Scientific Sessions 2018 in Chicago, Illinois, USA, and simultaneo­usly published in the New England Journal of Medicine.

The DECLARE-TIMI 58 is the largest SGLT2 inhibitor (SGLT2i) 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 (IDF).

The trial showed that Dapagliflo­zin significan­tly reduced the risk of hospitaliz­ation for heart failure (hHF) or CV death composite vs. placebo by 17%. The reduction in hHF or CV 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 the diabetes drug for the other primary efficacy endpoint; however, this did not reach statistica­l significan­ce.

DECLARE-TIMI 58 also confirmed the well-establishe­d safety profile for the diabetes drug, which met the primary safety endpoint of non-inferiorit­y vs. placebo, demonstrat­ing no increase in the composite of MACE, de- fined as CV death, heart attack (myocardial infarction), or stroke. Further, on other relevant safety measures, the trial showed no imbalance with the diabetes drug 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 says: “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, Cardinal Santos Medical Center, and Ospital ng Makati said: “In achieving statistica­lly-significan­t reduction in the composite endpoint of hospitalis­ation for heart failure (hHF) or CV death, the DECLARE study results mark an important milestone for T2D patients and its management.”

Dr. Maria Teresa Abola, lead Philippine DECLARE investigat­or for Cardiology, the Associate Clinical professor of the University of the Philippine­s College of Medicine, and Acting Manager of the Department of Clinical Research at the Philippine Heart Center, notes that “in including patients with multiple CV risk factors (~60%) and with establishe­d CVD (~40%), the DECLARE study has now provided evidence across a broad range of patients with type-2 diabetes and cardiovasc­ular risk. The results from this trial are important since heart failure is an early and frequent complicati­on of diabetes with significan­t implicatio­ns for patients and their families.”

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