FDA Approves Empagliflozin for HFpEF

By Debra L. Beck, MSc  |  March 3, 2022  |  Cardiovascular Disease, Emerging Medicine

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On February 24, 2022, the U.S. Food and Drug Administration (FDA) approved the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin 10 mg for the reduction of hard outcomes in adults with heart failure with preserved ejection fraction (HFpEF).

The approval is based on the findings of the phase 3 EMPEROR-Preserved trial, which showed in 5,988 patients with NYHA class II to IV symptoms and an EF > 40%, that treatment with once-daily empagliflozin 10 mg on top of guideline-directed HF therapy reduced the relative risk of the composite of cardiovascular death or hospitalization for heart failure by 21% (p<0.001), a difference mainly driven by a 29% lower risk of heart failure hospitalization with empagliflozin.

The approval is the first for an SGLT2 inhibitor for HFpEF and the third FDA approval for empagliflozin for a cardiovascular indication, following approvals for reducing the risk of cardiovascular death in patients with type 2 diabetes and established atherosclerotic cardiovascular disease and for the treatment of patients with heart-failure with reduced ejection fraction (HFrEF), with or without diabetes.

In a recent European Heart Journal article, Eugene Braunwald, MD, called SGLT2 inhibitors “the statins of the 21st century.”

Are you comfortable prescribing and managing these new agents in your heart failure patients?
Are you under-prescribing SGLT2 inhibitors because of a lack of perceived competence?

CurrentMD Cardiology is replete with content that can help you gain competence in prescribing (or managing patients taking) SGLT2 inhibitors.

This includes:

  • A new, 3-video Legends Series activity from heart failure specialist, Biykem Bozkurt, MD, PhD, that provides a comprehensive review of new and emerging treatments for HFrEF, including SGLT2 inhibitors, and a review and comment on recent data and guidelines changes in the treatment paradigms for patients with heart failure with mid-range and preserved ejection fractions.
  • Our AHA 2021 Meeting Report, where Ajay J. Kirtane, MD, and Deepak L. Bhatt, MD, MPH, describe the implications of recent clinical data concerning SGLT2 inhibitors for managing patients with heart failure.
  • Plus, numerous other on-demand, mobile-friendly activities to keep you up to date on your knowledge and your CME/MOC credits.

Biykem Bozkurt

As Dr. Bozkurt relays in one of her Legends Series activities, “Clinicians should feel the urgency to treat heart failure like cancer. Time is of the essence. Treatment prevents and improves outcomes.”

With this latest FDA approval, it’s time to get up to date on the newest treatments for heart failure. K2P is here to help.

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