title: A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease.
abstract: BACKGROUND
  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.
  
  
  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.
authors: Division of Hematology/Oncology, University of North Carolina, Chapel Hill.
authors: Payal C
authors: PC
authors: Desai
authors: Julia E
authors: JE
authors: Brittain
authors: Susan K
authors: SK
authors: Jones
authors: Adam
authors: A
authors: McDonald
authors: Douglas R
authors: DR
authors: Wilson
authors: Rosalie
authors: R
authors: Dominik
authors: Nigel S
authors: NS
authors: Key
authors: Leslie V
authors: LV
authors: Parise
authors: Kenneth I
authors: KI
authors: Ataga
mesh_terms: D059787:Acute Pain / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D000293:Adolescent; D000328:Adult; D000755:Anemia, Sickle Cell / Q000097:blood / Q000150:complications*; D004311:Double-Blind Method; D000077542:Eptifibatide; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D015539:Platelet Activation / Q000187:drug effects; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D000077542:Eptifibatide
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
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