![]() Moreover, concerns regarding potential side effects of the class prevented expansion of its use to a large proportion of patients with diabetes.ĭr. However, these effects were mainly demonstrated in type 2 diabetes patients with established CV disease and progressive renal disease who were at high risk for CV events and who represent a small proportion of the diabetic population. The new class of SGLT2 inhibitors is known to reduce cardiovascular risk factors and has also been shown to reduce hospitalization for heart failure, CV death, and renal deterioration. Raz: In spite of intensive therapy for controlling cardiovascular risk factors in patients with type 2 diabetes, increased cardiovascular (CV) and renal events still exist in this population, as does excess mortality. Raz is Professor of Internal Medicine and Director Emeritus of the Diabetes Unit at Hadassah University Medical Center in Jerusalem, Israel.ĭr. asked the study’s co-principal investigator, Itamar Raz, MD, to discuss the background, objective, and significance of the study. Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 1.8 million patient-years’ experience.Results from the Dapagliflozin Effect on Cardiovascular Events ( DECLARE-TIMI 58) trial will be presented at 2:15 p.m. ![]() The trial included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, US) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).įorxiga (dapagliflozin) is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporte 2 (SGLT2) indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D. Regulatory reviews and submissions are ongoing in several countries, including the US, China and Japan.ĭECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an AstraZeneca-sponsored, randomised, double-blinded, placebo-controlled, multicentre trial designed to evaluate the effect of Forxiga compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease. The trial showed no imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier’s gangrene. There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however this did not reach statistical significance.ĭECLARE-TIMI 58 confirmed the well-established safety profile of Forxiga. In DECLARE-TIMI 58, the largest and broadest CV outcomes trial conducted for a SGLT2 inhibitor to date, Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints. Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “We are pleased with this positive opinion for the cardiovascular outcomes and renal data for Forxiga and this recommendation acknowledges that even more people with type-2 diabetes could benefit from this medicine.” Click hereĪstraZeneca's Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes dataĪstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the hase III DECLARE-TIMI 58 trial. You can get e-magazine links on WhatsApp.
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