#Declare trial dapagliflozin full
The full results from today’s study can be found online in The Lancet Diabetes & Endocrinology. 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). An additional health economics analysis suggested that early use of dapagliflozin may reduce costs related to the treatment of CKD compared to placebo.
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. 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. “Medications like dapagliflozin should also be considered as first line therapy in patients without established cardiovascular disease.
Patients treated with the dapagliflozin experienced 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. Acute kidney injury occurred in 1.5% and 2.0% in the dapagliflozin and placebo arms, respectively. 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). 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). The analysis evaluated data from 17,160 patients with T2D and predominantly preserved renal function, irrespective of underlying ASCVD. 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. 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.ĭECLARE-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. 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).
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