What is the clinical evidence from this study?

Study design: RCT. Population: Heart failure with reduced ejection fraction (HFrEF) (n=190). Intervention: Empagliflozin vs. Placebo. Primary outcome: Between-group difference in the change of NT-proBNP from baseline to 12 weeks (adjusted ratio of change 0.98, 95% CI 0.82-1.11, p=0.7).

What question did this study set out to answer?

To assess the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on NT-proBNP levels, physical activity, and health status in patients with heart failure and reduced ejection fraction.

July 17, 2020American Heart JournalOpen Access

Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial

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Key result

Empagliflozin did not significantly change NT-proBNP levels compared to placebo over 12 weeks in patients with mildly symptomatic HFrEF (adjusted ratio of change 0.98; 95% CI 0.82-1.11; P=0.7).

Why the study?

The study was conducted to investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on NT-proBNP in patients with heart failure and reduced ejection fraction.

Does empagliflozin 10 mg once daily reduce NT-proBNP in patients with mildly symptomatic HFrEF on recommended HF therapy?

Comparison

Empagliflozin 10 mg once daily vs placebo

Design

Investigator-initiated, multi-center, double-blinded, placebo-controlled randomized trial

Follow-up

12 weeks

Authors

JJJ. Steen JensenGentofte Hospital MOMassar OmarHeart Failure & Transplant CKCaroline KistorpHeart Failure & Transplant

Discussion

Member takes

Implication

Empagliflozin does not lower NT-proBNP in mildly symptomatic HFrEF; challenges expectations of short-term biomarker response on optimal therapy.

Key Points

To assess the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on NT-proBNP levels, physical activity, and health status in patients with heart failure and reduced ejection fraction.
Investigator-initiated, multicenter, double-blind, placebo-controlled randomized trial (Empire HF) involving 190 patients with mildly symptomatic HFrEF on guideline-directed medical therapy.
Patients were randomized to receive empagliflozin 10 mg once daily (N=95) or matching placebo (N=95) for 12 weeks.
The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks.
No significant difference was observed in the 12-week change of NT-proBNP between empagliflozin and placebo (adjusted ratio of change 0.98; 95% CI 0.82–1.11, P = 0.7).
Accelerometer-measured daily activity levels showed no significant difference between groups (adjusted mean difference of change -26.0 counts; 95% CI -88.0 to 36.0, P = 0.4).
Kansas City Cardiomyopathy Questionnaire Overall Summary Score showed no significant change (adjusted mean difference of change 0.8; 95% CI -2.3 to 3.9, P = 0.6).

Study Design

Type

RCT (n=190)

Blinding

double-blinded

Randomization

randomized

Multicenter

Yes

Structured PICO

Does empagliflozin 10 mg once daily reduce NT-proBNP in patients with mildly symptomatic HFrEF on recommended HF therapy?

Population

190 patients with mildly symptomatic HFrEF (mean LVEF 29%) on recommended HF therapy, followed for 12 weeks.

Intervention

Empagliflozin 10 mg once daily for 12 weeks added to recommended HF therapy.

Comparator

Placebo for 12 weeks added to recommended HF therapy.

Outcome

Between-group difference in the change of NT-proBNP from baseline to 12 weeks.surrogate

Main Result

Effect estimate: adjusted ratio of change 0.98 (95% CI 0.82-1.11)

p-value: p=0.7

In low-risk patients with mildly symptomatic HFrEF, 12 weeks of empagliflozin treatment did not significantly change NT-proBNP levels, daily activity, or health status compared to placebo.

Cite This Study

Jensen et al. (2020) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) (n=190). Empagliflozin vs. Placebo was evaluated on Between-group difference in the change of NT-proBNP from baseline to 12 weeks (adjusted ratio of change 0.98, 95% CI 0.82-1.11, p=0.7). Empagliflozin did not significantly change NT-proBNP levels compared to placebo over 12 weeks in patients with mildly symptomatic HFrEF (adjusted ratio of change 0.98; 95% CI 0.82-1.11; P=0.7).

synapsesocial.com/papers/6a88555e5ee6e03ae3cf1e2a https://doi.org/10.1016/j.ahj.2020.07.011

Topics

HFrEF treatment Heart failure SGLT2 inhibitors in heart failure HFpEF management

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Implication

Empagliflozin does not lower NT-proBNP in mildly symptomatic HFrEF; challenges expectations of short-term biomarker response on optimal therapy.

Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider