Phase III VICTORIA study of BAY 1021189 shows reduced risk of hospitalisation or death in heart failure.- Merck Inc + Bayer Healthcare
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The FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance (empagliflozin) 10 mg, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction (LVEF), Boehringer Ingelheim and Eli Lilly and Company announced.
Bayer and its development partner Merck Inc., announced the start of VICTOR (VerICiguaT in adults with ChrOnic heart failure and Reduced ejection fraction), a new Phase III cardiovascular study investigating the expanded use of heart failure (HF) treatment vericiguat.
Jardiance (empagliflozin), from Eli Lilly and Boehringer, reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved phase III trial. In EMPEROR-Preserved, two thirds of enrolled adults had heart failure with preserved ejection fraction (HFpEF; LVEF of at least 50%) and one third had mildly reduced LVEF (greater than 40% but less than 50%).