Physicians' Academy for Cardiovascular Education

Reversal of beneficial CV effects of SGLT2i in HF after short withdrawal period

News - Aug. 27, 2023

Blinded withdrawal of long-term randomized treatment with empagliflozin or placebo in patients with heart failure

Presented at the ESC Congress 2023 by: Milton Packer, MD - Dallas, TX, USA

Introduction and methods

It is usually recommended that the foundational HF medications need to be taken indefinitely by patients who can tolerate these medications. However, it has never been studied whether these drugs are still effective after many years.

After the EMPEROR-Reduced and EMPEROR-Preserved trials, a protocol-mandated, blinded withdrawal of randomized study medication was performed at the end of the planned double-blind therapy. A total of 6799 patients were prospectively withdrawn from treatment. Of these patients, 3981 patients completed a 30 day withdrawal period with in-person off-treatment assessment (n=1961 in the empagliflozin group, and n=2020 in the placebo group). The primary endpoint was the composite of CV death or HF hospitalization.

Main results


Withdrawal of empagliflozin in patients with HFrEF or HFpEF increased the risk of CV death or HF hospitalization. “Regardless of the mechanisms, our findings indicate that tolerance does not develop during long-term treatment with empagliflozin in patients with heart failure and, very importantly, that cessation of treatment even for short periods of time may have deleterious clinical consequences.”, according to Milton Packer.

- Our reporting is based on the information provided at the ESC Congress 2023 -

The results of this study were simultaneously published in Circulation Watch a video with Milton Packer on this study

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