![]() When compared to those with no history of HF, HFrEF patients were more likely to have established ASCVD (86% vs. Significant Decrease in Risks for HF Patientsįor the Latebreaker presentation on outcomes in patients enrolled in DECLARE-TIMI 58 with HF, patients were stratified in those with HFrEF (671 patients), defined as ejection fraction <45%, those with history of HF HF without a reduced ejection fraction (808 patients), those with a history of HF but no baseline measurement of ejection fraction (508 patients), and those with no history of HF (15,173 patients). Even though only 6% entered with a history of peripheral artery disease (PAD), this represented more than 1,000 patients. In addition, approximately 10% of patients in DECLARE-TIMI 58 had a history of HF. One third had a history of atherosclerotic CV disease (ASCVD) of which approximately two thirds had a history of prior MI. This still left a substantial proportion with established CV disease. Unlike EMPA-REG, which required a history of established CV disease for entry, two thirds of the participants in DECLARE-TIMI 58 were enrolled on the basis of CV risk factors alone. Relative to the two previous CV safety trials conducted with a SGLT2 inhibitor, EMPA-REG and CANVAS, DECLARE-TIMI 58 was by far the largest, randomizing 17,160 individuals with T2DM to dapagliflozin or placebo. The findings were published simultaneously (Kato et al. Eri Toda Kato, Assistant Professor, Kyoto University Graduate School of Medicine, Japan, who presented these data as a Latebreaker session at the ACC meeting. “These benefits were seen with similar safety profile for dapagliflozin regardless of HF status,” reported Dr. “These benefits were seen with similar safety profile for dapagliflozin regardless of heart failure status.” Based on these data, the number needed to treat to prevent one death over four years was calculated at just 16. On the basis of hazard ratio (HR), there was a 41% reduction in risk of all-cause mortality (HR 0.59) for HFrEF patients for dapagliflozin relative to placebo at the end of follow-up (Figure 1). In the HFrEF population, the relative mortality benefit observed in the sub-analysis was large. Lawrence Leiter on the impact to clinical practice, click here ![]() The new sub-analysis of DECLARE-TIMI 58 expand the evidence that dapagliflozin is not only safe in high-risk patients but also leads to even greater CV protection.įor an exclusive interview with Dr. With data from a pre-specified sub-analysis of the DECLARE-TIMI 58 trial published just weeks ago, results associated the SGLT2 inhibitor dapagliflozin with a 17% reduction (HR 0.83 P=0.005) in CV death and hospitalization for heart failure (HF) (Wiviott SD et al. Coupled with the established protection against renal disease, these data substantiate fundamental benefits against the most important sources of morbidity and mortality in T2DM. In those with prior MI, this included a reduction in major adverse cardiovascular events (MACE) mainly driven by a reduction on new MI events. In those with HFrEF, this included a reduction in CV mortality, hospitalization for heart failure and in all-cause mortality. This included large absolute protection against CV events in those who entered the trial with reduced ejection fraction heart failure (HFrEF) and those with a history of myocardial infarction (MI). New Orleans – In patients with type 2 diabetes mellitus (T2DM), new data from a SGLT2 inhibitors cardiovascular (CV) safety trial have shown the greatest relative protection in those at highest risk. March 16-18, 2019 / New Orleans, Louisiana DECLARE-TIMI 58 Sub-analyses: Expanding Evidence of Cardiovascular Protection across Broad Spectrum of Patients ![]() Cardiology American College of Cardiology (ACC) 2019 Scientific Sessions ![]()
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