UPPSALA,
Empagliflozin, approved in the US under the tradename JARDIANCE, is a product used to lower blood sugar in patients with type 2 diabetes, and also to reduce the risk of cardiovascular death in those with type 2 diabetes who have known cardiovascular disease. JARDIANCE is also under Priority Review at the
“While the beneficial cardiovascular and renal effects of SGLT-2 inhibitors have been demonstrated in multiple clinical trials, the precise molecular mechanism of those effects is not well understood,” said
“It is hoped that these analyses by
The analyses will collect and measure circulating protein biomarkers in 1,500 blood samples from EMPEROR-Reduced and 1,500 blood samples from EMPEROR-Preserved in an effort to reveal a potential mode of action and the underlying biology in patients with heart failure. Sample collection, and proteomic analyses and data delivery occurred during the third quarter of 2021, with analyses now ongoing. It is expected that the results of these analyses will be communicated by
About the Emperor Studies
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) studies in chronic heart failure, were conducted in patients with and without diabetes, and were two Phase 3, randomized, double-blind trials that investigated once-daily empagliflozin compared to placebo in adults with chronic HFrEF (heart failure with reduced ejection fraction) or HFpEF (heart failure with preserved ejection fraction).
EMPEROR-Preserved was a Phase 3 international, randomized, double-blind trial that enrolled 5,988 adults with and without type 2 diabetes. All participants had heart failure (
EMPEROR-Reduced was a Phase 3 international, randomized, double-blind trial that enrolled 3,730 patients with NYHA class II, III, or IV heart failure and an ejection fraction of 40% or less. Study participants received empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. Overall, in this trial empagliflozin was associated with a lower combined risk of cardiovascular death or hospitalization for heart failure than placebo, and with a slower progressive decline in renal function in patients with chronic heart failure and a reduced ejection fraction, regardless of the presence or absence of diabetes.
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