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Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure
Milton Packer1,2, Javed Butler3,4, Cordula Zeller5
1Baylor University Medical Center, Dallas, TX (M.P.).
Circulation
|August 25, 2023
Summary
Sodium-glucose cotransporter 2 inhibitors like empagliflozin show persistent benefits in heart failure patients. These benefits in heart failure care diminish rapidly upon drug withdrawal, highlighting long-term efficacy.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- The long-term persistence of benefits from sodium-glucose cotransporter 2 inhibitors (SGLT2i) in heart failure management remains unclear.
- Previous trials like EMPEROR-Reduced and EMPEROR-Preserved demonstrated efficacy over a median of 16-26 months.
Purpose of the Study:
- To investigate whether the cardiovascular and symptomatic benefits of empagliflozin in heart failure persist after treatment withdrawal.
- To assess the impact of discontinuing empagliflozin on clinical outcomes and physiological markers.
Main Methods:
- Patients from EMPEROR-Reduced and EMPEROR-Preserved trials were withdrawn from empagliflozin or placebo.
- A subset of patients underwent in-person assessments approximately 30 days after drug withdrawal.
- Clinical outcomes (cardiovascular death, heart failure hospitalization) and patient-reported symptoms (Kansas City Cardiomyopathy Questionnaire) were evaluated.
Main Results:
- The risk of cardiovascular death or heart failure hospitalization increased significantly after empagliflozin withdrawal compared to placebo.
- Patient-reported symptoms, measured by the Kansas City Cardiomyopathy Questionnaire, declined after empagliflozin withdrawal.
- Withdrawal of empagliflozin reversed beneficial physiological changes, including improvements in glucose levels, body weight, and natriuretic peptides.
Conclusions:
- Empagliflozin demonstrates a persistent beneficial effect in heart failure patients, even after prolonged treatment.
- The observed benefits of empagliflozin dissipate rapidly following drug discontinuation.
- These findings underscore the sustained impact of SGLT2 inhibitors in heart failure therapy.
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