What is the clinical evidence from this study?

Study design: RCT. Population: Acute Decompensated Heart Failure (n=30). Intervention: Anakinra vs. Placebo. Primary outcome: Interval changes in CRP plasma levels at 72 hours versus baseline (p=0.004).

What question did this study set out to answer?

To evaluate whether interleukin-1 blockade with anakinra suppresses the acute systemic inflammatory response in patients hospitalized with acute decompensated heart failure.

February 23, 2016Journal of Cardiovascular PharmacologyOpen Access

Interleukin-1 Blockade in Acute Decompensated Heart Failure

Q: What are the key findings of this study?

Anakinra reduced CRP levels by 61% at 72 hours compared to a 6% reduction with placebo in patients with acute decompensated heart failure (P=0.004).

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Key result

Anakinra cuts CRP by ~61% at 72 hours vs placebo in ADHF.

P=0.004
n=30

Why the study?

Does anakinra reduce systemic inflammation (CRP levels) in patients with acute decompensated heart failure with reduced ejection fraction?

Population

n=30 patients with acute decompensated heart failure, reduced left ventricular ejection fraction, and…

Comparison

Anakinra 100 mg twice daily for 3 days followed… vs Matching placebo

Design

RCT, 1:1, double blinded

Follow-up

14 days

Authors

BTBenjamín W. Van TassellHeart Failure & Transplant NANayef AbouzakiMedStar Washington Hospital Center CEClaudia Oddi ErdleVirginia Commonwealth University

Discussion

Member takes

Implication

Anakinra attenuates acute inflammation in decompensated HF; extends IL-1 blockade evidence to a new population.

Key Points

To evaluate whether interleukin-1 blockade with anakinra suppresses the acute systemic inflammatory response in patients hospitalized with acute decompensated heart failure.
Randomized 30 patients with acute decompensated heart failure, reduced left ventricular ejection fraction (<40%), and elevated CRP (≥5 mg/L) 1:1 to anakinra or matching placebo in a double-blind fashion.
Administered anakinra (100 mg twice daily for 3 days, then once daily for 11 days) or matching placebo.
Measured daily high-sensitivity CRP plasma levels during hospitalization and at day 14 to calculate interval changes and area-under-the-curve.
Treatment with anakinra was well tolerated throughout the study duration.
At 72 hours, anakinra reduced plasma CRP levels by 61% versus baseline, compared with a 6% reduction in the placebo group (P = 0.004).

Study Design

Type

RCT (n=30)

Blinding

Double-blind

Randomization

1:1

Structured PICO

Does anakinra reduce systemic inflammation (CRP levels) in patients with acute decompensated heart failure with reduced ejection fraction?

Population

n=30 patients with acute decompensated heart failure (ADHF), reduced left ventricular ejection fraction (<40%), and elevated C reactive protein (CRP) levels (≥5 mg/L)

Intervention

Anakinra 100 mg twice daily for 3 days followed by once daily for 11 days

Comparator

Matching placebo

Outcome

Daily CRP plasma levels (area-under-the-curve and interval changes) measured using a high-sensitivity assay during hospitalization and at 14 dayssurrogate

Main Result

Absolute Event Rate: 61% vs 6%

p-value: p=0.004

Interleukin-1 blockade with anakinra significantly reduces the acute systemic inflammatory response in patients with acute decompensated heart failure.

Cite This Study

Tassell et al. (2016) conducted an RCT in Acute Decompensated Heart Failure (n=30). Anakinra vs. Placebo was evaluated on Interval changes in CRP plasma levels at 72 hours versus baseline (p=0.004). Anakinra reduced CRP levels by 61% at 72 hours compared to a 6% reduction with placebo in patients with acute decompensated heart failure (P=0.004).

synapsesocial.com/papers/6a087f67ab15ea61dee8e2d1 https://doi.org/10.1097/fjc.0000000000000378

Topics

HFrEF treatment Heart failure

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Interleukin-1 Blockade in Acute Decompensated Heart Failure

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Interleukin-1 Blockade in Acute Decompensated Heart Failure

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider