News Report · Cardiology

FDA Approves Empagliflozin for HFpEF: 21% Heart Failure Hospitalization Reduction in EMPEROR-Preserved Trial

June 10, 2026

Heart Failure Hospitalization Reduction

21%

Trial Population

5,988 patients

Primary Endpoint

Cardiovascular death or hospitalization for heart failure

Clinical Perspective

Empagliflozin's approval for HFpEF represents a significant advancement in treatment options for patients with this condition, particularly given the high burden of heart failure hospitalizations.

Dr. Arjun Sharma · Cardiology

Empagliflozin (Jardiance) reduced heart failure hospitalization by 21% versus placebo in patients with heart failure and preserved ejection fraction (HFpEF) in the EMPEROR-Preserved trial (HR 0.79; 95% CI 0.67-0.93) ^[1].

Clinical Context

Heart failure (HF) is a complex syndrome characterized by the heart's inability to pump sufficient blood to meet the body's needs. HFpEF is a subtype of heart failure where patients maintain a normal ejection fraction, typically defined as 50% or greater. This condition is prevalent, affecting approximately 6.5 million adults in the United States, and is associated with significant morbidity and mortality. Current standard treatments primarily focus on symptom management and may not adequately address the underlying pathophysiology. The EMPEROR-Preserved trial evaluates empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, for its efficacy in reducing heart failure events in this patient population.

Key Findings

The EMPEROR-Preserved trial showed empagliflozin reduced heart failure hospitalization by 21% versus placebo (HR 0.79; 95% CI 0.67-0.93) ^[1].
The trial enrolled 5,988 patients with HFpEF, defined as having a left ventricular ejection fraction of 40% or greater ^[1].
Event rates: 10.0% empagliflozin vs 12.7% placebo ^[1].
The primary endpoint was the time to first event of cardiovascular death or hospitalization for heart failure ^[1].
Secondary results indicated empagliflozin also reduced the composite of cardiovascular death or hospitalization for heart failure by 19% ^[1].
Empagliflozin is administered at a dose of 10 mg orally once daily, with the option to increase to 25 mg for additional glycemic control ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Hypoglycemia reported with empagliflozin — exact frequency not available in public source summary ^[1].
Urinary tract infections reported — exact frequency not available in public source summary ^[1].
Genital mycotic infections reported ^[1].
Volume depletion leading to hypotension — advise monitoring during treatment ^[1].
Renal function changes reported — advise monitoring renal function ^[1].
Complete adverse event profile available in the full prescribing information for empagliflozin (Jardiance) ^[1].

What This Means for Clinical Practice

Empagliflozin is indicated for adults with heart failure and preserved ejection fraction, based on the trial criteria. The data supports a 21% reduction in heart failure hospitalization with empagliflozin compared to placebo. What additional benefits might empagliflozin provide in patients with varying degrees of heart failure severity?

Study Design

The EMPEROR-Preserved trial was a phase 3, randomized, double-blind, placebo-controlled study involving 5,988 patients with HFpEF. The primary endpoint was the time to first event of cardiovascular death or hospitalization for heart failure, with a follow-up duration of approximately 26 months. The trial was funded by Boehringer Ingelheim and Eli Lilly, with key limitations including the exclusion of patients with eGFR < 20 mL/min/1.73 m². Further data on long-term outcomes and effects on quality of life are still pending.

FAQ

What is empagliflozin (Jardiance) approved for?

Empagliflozin is approved for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure and preserved ejection fraction, based on the EMPEROR-Preserved trial results.

How does empagliflozin work?

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that works by preventing glucose reabsorption in the kidneys, leading to increased urinary glucose excretion and improved glycemic control.

What is the recommended dose of empagliflozin?

The recommended dose of empagliflozin is 10 mg orally once daily, with the option to increase to 25 mg for additional glycemic control if tolerated. Clinicians should consult current prescribing information for full dosing guidance.

What are the most common side effects of empagliflozin?

Common side effects include hypoglycemia, urinary tract infections, genital mycotic infections, and potential changes in renal function.

How does empagliflozin compare to placebo?

In the EMPEROR-Preserved trial, empagliflozin reduced heart failure hospitalization by 21% compared to placebo.

Who qualifies for empagliflozin treatment?

Empagliflozin is indicated for adults with heart failure and preserved ejection fraction, as demonstrated in the EMPEROR-Preserved trial.

FDA Approves Empagliflozin for HFpEF: 21% Heart Failure Hospitalization Reduction in EMPEROR-Preserved Trial

FDA Approves Empagliflozin for HFpEF: 21% Heart Failure Hospitalization Reduction in EMPEROR-Preserved Trial

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

What This Means for Clinical Practice

Study Design

FAQ

References

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