Acute thrombocytopenia in patients treated with the oral glycoprotein IIb/IIIa inhibitors xemilofiban and orbofiban: evidence for an immune etiology

Thromb Haemost. 2002 Dec;88(6):892-7.

Abstract

Thrombocytopenic episodes occurring in 18,845 patients treated with the GPIIb/IIIa inhibitors xemilofiban and orbofiban ("fibans") were analyzed by a blinded review panel and 73 patients were classified as having "possible fiban-induced thrombocytopenia". When the treatment codes were broken, a significant association between drug exposure and assignment to this group was found (p <0.001). Twenty-eight (82%) of 34 archived serum samples from these patients contained fiban-dependent antibodies specific for GPIIb/IIIa, but no such antibodies were found in 61 drug treated patients not classified as having "possible fiban-induced thrombocytopenia" (p <0.001). We conclude that fiban-dependent antibodies were the major cause of acute, severe thrombocytopenia in patients judged on the basis of clinical findings to have thrombocytopenia "possibly-induced" by xemilofiban and orbofiban. Measurement of drug-dependent antibodies may be helpful in determining the basis for acute thrombocytopenia in fiban-treated patients and possibly for identification of patients at risk to develop thrombocytopenia.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acute Disease
  • Alanine / administration & dosage
  • Alanine / adverse effects*
  • Autoantibodies / blood
  • Autoimmunity
  • Benzamidines / administration & dosage
  • Benzamidines / adverse effects*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / adverse effects*
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Platelet Glycoprotein GPIIb-IIIa Complex / immunology
  • Purpura, Thrombocytopenic, Idiopathic / etiology
  • Purpura, Thrombocytopenic, Idiopathic / immunology
  • Pyrrolidines / administration & dosage
  • Pyrrolidines / adverse effects*
  • Risk Factors
  • Thrombocytopenia / etiology*
  • Thrombocytopenia / immunology

Substances

  • Autoantibodies
  • Benzamidines
  • Platelet Aggregation Inhibitors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Pyrrolidines
  • orbofiban
  • Alanine
  • xemilofiban