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Thromb Res. 2013 Sep;132(3):341-5. doi: 10.1016/j.thromres.2013.08.002. Epub 2013 Aug 8.

A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease.

Author information

1
Division of Hematology/Oncology, University of North Carolina, Chapel Hill.

Abstract

INTRODUCTION:

The contribution of platelet activation to the pathogenesis of sickle cell disease (SCD) remains uncertain. We evaluated the safety and efficacy of eptifibatide, a synthetic peptide inhibitor of the αIIbβ3 receptor, in SCD patients during acute painful episodes.

MATERIALS AND METHODS:

In this single site, double-blind, placebo-controlled trial, eligible patients with SCD admitted for acute painful episodes were randomized to receive eptifibatide or placebo at a ratio of 2:1.

RESULTS:

Thirteen patients (SS - 10, Sβ(0) - 2, SC - 1) were randomized to receive either eptifibatide (N=9; 6 females; median age - 25years) or placebo (N=4; 3 females; median age - 31years). In the intent-to-treat analysis, there were no major bleeding episodes in either the eptifibatide or placebo arms (point estimate of difference: 0.00, 95% CI; -0.604, 0.372). There was one minor bleeding episode in the eptifibatide arm (point estimate of difference for any bleeding: 0.11, 95% CI: -0.502, 0.494). There was no significant difference in the proportion of patients with thrombocytopenia between the treatment groups (point estimate of difference: 0.11, 95% CI: -0.587, 0.495). There were no differences in the median times to discharge, median times to crisis resolution or the median total opioid use.

CONCLUSIONS:

In this small study, eptifibatide appeared to be safe, but did not improve the times to crisis resolution or hospital discharge. Adequately powered studies are required to evaluate the safety and efficacy of eptifibatide in SCD. Clinicaltrials.gov Identifier: NCT00834899.

KEYWORDS:

Acute painful episode; CD40 ligand; CD40L; CI; Eptifibatide; PCA; Platelet activation; SCD; Safety; Sickle cell disease; confidence intervals; patient controlled analgesia; sickle cell disease

PMID:
23973010
PMCID:
PMC3791139
DOI:
10.1016/j.thromres.2013.08.002
[Indexed for MEDLINE]
Free PMC Article

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