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Message: FDA approves "empagliflozin" for reducing risk of cardiovascular death, hospitalization among adult HFpEF patients
Cardiology groups debut new heart failure guidelines ahead of ACC.22
Michael Walter | April 01, 2022 | Heart Failure
The U.S. Food and Drug Administration (FDA) has approved "Empagliflozin" (SGLT2 inhibitor by Jardiance) as a treatment option for reducing the risk of cardiovascular mortality and hospitalization among adult heart failure patients, regardless of left ventricular ejection fraction.
This is what we know from the Results of BetOnMace1:
"Critically Important Finding, Patents Filed – Potential Synergy with New Generation of Diabetes Drugs –
Primary Endpoint in Patients Receiving SGLT2i
- All SGLT2i’s: 60% Hazard Reduction (HR: 0.40; 95% CI; 0.16-1.00) p=0.05 (non-QC’d)
- Empagliflozin: 66% Hazard Reduction (HR: 0.34; 95% CI; 0.12-1.01) p=0.05 (non-QC’d)
- Hit on Hospitalization for Congestive Heart Failure (CHF): 41% Hazard Reduction (HR: 0.59; 95% CI; 0.38- 0.94) p=0.03
Apabetalone: "Breakthrough Therapy Status" Granted from FDA – February 2020 –
Agreement reached with FDA for key aspects of apabetalone registration enabling study at June 2020 Meeting."
FDA’s Breakthrough Therapy Status is defined as a process that aims to accelerate the development and review of drugs for serious conditions.
BetOn Mace 2, will hopefully get us where we need to be and soon.
Koo
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