The first was cardiovascular death and hospitalization for heart failure the second was a standard that we call MACE outcome, which was myocardial infarction, stroke, and cardiovascular death. So, this was a large randomized clinical trial of dapagliflozin in that population of patients.We had 2 different outcomes that we were assessing for as our primary assessment. We were assessing the safety and efficacy of a drug called dapagliflozin, which is one of the members of the class of SGLT2 inhibitors. So, this was a trial of patients who both had pre-existing cardiovascular disease and patients who had diabetes and who were at risk for cardiovascular disease, so both primary and secondary prevention. What were you investigating in the DECLARE-TIMI 58 trial? What was surprising about the DECLARE-TIMI 58 trial results? “Dapagliflozin did not result in a significantly lower rate of MACE, but in a broad population of patients with type 2 diabetes it did result in a significantly lower rate of cardiovascular death or hospitalization for heart failure than placebo, with additional findings supporting a possible lower rate of adverse renal outcomes,” concluded authors led by Wiviott in a paper published in the New England Journal of Medicine. 02) and genital infections that led to discontinuation or were considered serious adverse events (.9% vs.1%, HR 8.36 95% CI 4.19-16.68 P <.001).ĭapagliflozin did appear to have renal benefits, with a renal event occurring in 4.3% of the dapagliflozin group and in 5.6% in the placebo group (HR. 17).Ĭertain adverse events were more common in the dapagliflozin group compared to placebo, including diabetic ketoacidosis (.3% vs.1% HR 2.18 95% CI 1.10-4.30 P =. Rates of MACE were 8.8% in the dapagliflozin group and 9.4% in the placebo group (HR. However, the trial did not meet the other primary efficacy endpoint of lowering MACE, though it did meet the prespecified noninferiority criterion with regards to MACE, which was the primary safety outcome (upper boundary of the 95% CI <1.3 P <.001 for noninferiority). 61-.88) as there was no between-group difference in the rates of cardiovascular death (HR. That difference was primarily driven by differences in the rate of hospitalization for heart failure (HR. Meeting one of the primary efficacy points, dapagliflozin did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs.
A total of 3962 patients discontinued participation, including 21.1% of those in the dapagliflozin group and 25.1% of those in the placebo group. Participants were randomized to either 10 mg dapagliflozin (n = 8582) or placebo (n =8578). “I think one implication is that this extends out the benefit to a broader population of patients,” said Wiviott.Īfter a run-in period, the DECLARE study included 17,160 patients with type 2 diabetes and either cardiovascular disease (40.6%, n = 6974) or multiple risk factors for cardiovascular disease (59.4%, n = 10,186). These patients are those with type 2 diabetes who are at risk for, but who don’t already have atherosclerotic cardiovascular disease. Wiviott told MD Magazine® that the DECLARE-TIMI 58 study included a broader population than many previous studies of SGLT2 inhibitors, with nearly 60% of participants in the primary prevention population. Results from the DECLARE-TIMI 58 trial were presented by Stephen Wiviott, MD, senior investigator of the TIMI Study Group, cardiologist at Brigham and Women’s Hospital, and Associate Professor of Medicine at Harvard Medical School, at the American Heart Association’s Scientific Sessions 2018 in Chicago, IL. However, dapagliflozin did not reduce major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. Data from the DECLARE-TIMI 58 trial of dapagliflozin show that the SGLT2 inhibitor reduced rates of cardiovascular death or hospitalization for heart failure compared to placebo (4.9% vs.
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