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

Payal C. Desai, Julia E. Brittain, Susan K. Jones, Adam McDonald, Douglas R. Wilson, Rosalie Dominik, Nigel S. Key, Leslie V. Parise, Kenneth Ataga

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21 Citations (Scopus)

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, Sβ0 - 2, SC - 1) were randomized to receive either eptifibatide (N = 9; 6 females; median age - 25 years) or placebo (N = 4; 3 females; median age - 31 years). 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.

Original languageEnglish (US)
Pages (from-to)341-345
Number of pages5
JournalThrombosis Research
Volume132
Issue number3
DOIs
StatePublished - Sep 1 2013
Externally publishedYes

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Acute Pain
Sickle Cell Anemia
Placebos
Hemorrhage
Therapeutics
Safety
Platelet Activation
eptifibatide
Thrombocytopenia
Opioid Analgesics
Peptides

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Desai, P. C., Brittain, J. E., Jones, S. K., McDonald, A., Wilson, D. R., Dominik, R., ... Ataga, K. (2013). A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease. Thrombosis Research, 132(3), 341-345. https://doi.org/10.1016/j.thromres.2013.08.002

A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease. / Desai, Payal C.; Brittain, Julia E.; Jones, Susan K.; McDonald, Adam; Wilson, Douglas R.; Dominik, Rosalie; Key, Nigel S.; Parise, Leslie V.; Ataga, Kenneth.

In: Thrombosis Research, Vol. 132, No. 3, 01.09.2013, p. 341-345.

Research output: Contribution to journalArticle

Desai, PC, Brittain, JE, Jones, SK, McDonald, A, Wilson, DR, Dominik, R, Key, NS, Parise, LV & Ataga, K 2013, 'A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease', Thrombosis Research, vol. 132, no. 3, pp. 341-345. https://doi.org/10.1016/j.thromres.2013.08.002
Desai PC, Brittain JE, Jones SK, McDonald A, Wilson DR, Dominik R et al. A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease. Thrombosis Research. 2013 Sep 1;132(3):341-345. https://doi.org/10.1016/j.thromres.2013.08.002
Desai, Payal C. ; Brittain, Julia E. ; Jones, Susan K. ; McDonald, Adam ; Wilson, Douglas R. ; Dominik, Rosalie ; Key, Nigel S. ; Parise, Leslie V. ; Ataga, Kenneth. / A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease. In: Thrombosis Research. 2013 ; Vol. 132, No. 3. pp. 341-345.
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N2 - 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, Sβ0 - 2, SC - 1) were randomized to receive either eptifibatide (N = 9; 6 females; median age - 25 years) or placebo (N = 4; 3 females; median age - 31 years). 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.

AB - 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, Sβ0 - 2, SC - 1) were randomized to receive either eptifibatide (N = 9; 6 females; median age - 25 years) or placebo (N = 4; 3 females; median age - 31 years). 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.

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