SAN FRANCISCO, June 9, 2019 /PRNewswire/ -- The first sub-analysis of renal data from the Dapagliflozin Effect on Cardiovascular Events Thrombolysis In Myocardial Infarction (DECLARE-TIMI 58) trial indicates that dapagliflozin, an oral sodium glucose cotransporter 2 (SGLT2) inhibitor, reduced the progression of kidney disease or renal death in patients with type 2 diabetes (T2D). The initial results from the trial, the first cardiovascular outcome study to enroll a large cohort of patients with diabetes risk factors for Atherosclerotic Cardiovascular Disease (ASCVD) and a large number of patients with diabetes with known ASCVD, were presented today at the American Diabetes Association's® (ADA's) 79th Scientific Sessions® at the Moscone Convention Center in San Francisco.
DECLARE-TIMI is a multi-national, randomized, double-blind, placebo-controlled Phase III-B trial and is a superiority trial designed to test the hypothesis that, in patients with T2D, long-term treatment with dapagliflozin will reduce one or both of the co-primary endpoints: 1) the incidence of cardiovascular death, myocardial infarction, or ischemic stroke or 2) the incidence of cardiovascular death or hospitalization for heart failure.
In the first sub-analysis of renal data from Phase III, researchers found a 47% reduction within the relative risk of kidney function decline, end-stage renal disease (ESRD), or renal death (excluding cardiovascular death) compared to placebo (1.5% vs. 2.6%; HR 0.53 [95% CI 0.43-0.66], p<0.0001).The risk of end-stage renal disease or renal death was lower in the dapagliflozin group than in the placebo group (11[0.1%] vs. 27 [0.3%]; HR 0.41 [95% CI 0.20-0.82]; p=0.012).
The analysis evaluated data from 17,160 patients with T2D and predominantly preserved renal function, irrespective of underlying ASCVD. Patients with diabetes are between six and 12 times more likely to develop ESRD and are twice as likely to develop chronic kidney disease (CKD). While ESRD was a rare event in the trial, dapagliflozin significantly reduced the incidence when compared to the placebo (0.1% vs 0.3%, respectively). Acute kidney injury occurred in 1.5% and 2.0% in the dapagliflozin and placebo arms, respectively. Patients treated with the dapagliflozinexperienced fewer clinically important renal outcomes, regardless of eGFR or urinary albumin-to-creatinine ratio (UACR) category, whether they had established ASCVD or multiple CV risk factors.
"Medications like dapagliflozin should also be considered as first line therapy in patients without established cardiovascular disease. The drugs have a high safety margin and should be used regularly by primary care physicians," said Itamar Raz, MD, professor of internal medicine at Hadassah Medical School at the Hebrew University of Jerusalem, head of the Israel National Council of Diabetes, and previous head of the Diabetes Unit at Hadassah University Hospital.
The results were presented alongside other renal outcomes from DECLARE-TIMI 58, including positive results from an analysis that found dapagliflozin both reduced and prevented the worsening of UACR, a key marker of kidney health, across all UACR categories and regardless of a patient's baseline UACR. An additional health economics analysis suggested that early use of dapagliflozin may reduce costs related to the treatment of CKD compared to placebo.
Researchers enrolled more than 17,000 patients across 882 sites from 33 countries, and the trial ran independently in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel). The full results from today's study can be found online in The Lancet Diabetes & Endocrinology.
To speak with lead investigators Dr. Raz or Dr. Leiter, please contact the ADA Press Office on-site at San Francisco's Moscone Convention Center on June 7-11, by phone at 415-978-3606 or by email at [email protected].
The American Diabetes Association's 79th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention and care, is being held June 7-11, 2019, at the Moscone Center in San Francisco, California. Nearly 15,000 leading physicians, scientists, health care professionals and industry representatives from around the world have convened at the Scientific Sessions to unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. During the five-day meeting, attendees receive exclusive access to more than 850 presentations and 2,000 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight thematic areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Gretchen Youssef, MS, RDN, CDE, President of Health Care and Education, delivered her address, "It's All About Access!," on Saturday, June 8, and Louis H. Philipson, MD, PhD, FACP, President of Medicine and Science, delivered his lecture, "Precision Medicine—Addressing the Many Faces of Diabetes," on Sunday, June 9. Join the Scientific Sessions conversation on social media using #ADA2019.
About the American Diabetes Association Every day more than 4,000 people are newly diagnosed with diabetes in America. Nearly 115 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Information is available in English and Spanish. Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).