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February 23, 2016Journal of Cardiovascular Pharmacology131 citationsOpen Access

Interleukin-1 Blockade in Acute Decompensated Heart Failure

BTBenjamín W. Van TassellNANayef AbouzakiCEClaudia Oddi Erdle

Key Result

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).

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?

P
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)
I
Intervention
Anakinra 100 mg twice daily for 3 days followed by once daily for 11 days
C
Comparator
Matching placebo
O
Outcome
Daily CRP plasma levels (area-under-the-curve and interval changes) measured using a high-sensitivity assay during hospitalization and at 14 dayssurrogate

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

Main Result

Absolute Event Rate: 61% vs 6%

p-value: p=0.004

Abstract

BACKGROUND: Heart failure is an inflammatory disease. Patients with acute decompensated heart failure (ADHF) exhibit significant inflammatory activity on admission. We hypothesized that Interleukin-1 blockade, with anakinra (Kineret, Swedish Orphan Biovitrum), would quench the acute inflammatory response in patients with ADHF. METHODS: We randomized 30 patients with ADHF, reduced left ventricular ejection fraction (<40%), and elevated C reactive protein (CRP) levels (≥5 mg/L) to either anakinra 100 mg twice daily for 3 days followed by once daily for 11 days or matching placebo, in a 1:1 double blinded fashion. We measured daily CRP plasma levels using a high-sensitivity assay during hospitalization and then again at 14 days and evaluated the area-under-the-curve and interval changes (delta). RESULTS: Treatment with anakinra was well tolerated. At 72 hours, anakinra reduced CRP by 61% versus baseline, compared with a 6% reduction among patients receiving placebo (P = 0.004 anakinra vs. placebo). CONCLUSIONS: Interleukin-1 blockade with anakinra reduces the systemic inflammatory response in patients with ADHF. Further studies are warranted to determine whether this anti-inflammatory effect translates into improved clinical outcomes.

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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/6a087f67ab15ea61dee8e2d1https://doi.org/10.1097/fjc.0000000000000378
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