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Safety, Efficacy, and Dosing Requirements of Bivalirudin in Patients with Heparin‐Induced Thrombocytopenia
Author(s) -
Kiser Tyree H.,
Burch Jessica C.,
Klem Patrick M.,
Hassell Kathryn L.
Publication year - 2008
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.28.9.1115
Subject(s) - medicine , bivalirudin , dosing , partial thromboplastin time , creatinine , renal function , heparin , intensive care unit , retrospective cohort study , anesthesia , heparin induced thrombocytopenia , surgery , urology , platelet , percutaneous coronary intervention , myocardial infarction
Study Objective . To evaluate the safety, efficacy, and dosing requirements of bivalirudin in patients with heparin‐induced thrombocytopenia (HIT). Design . Retrospective cohort study. Setting . University‐affiliated hospital. Patients . Thirty‐seven adults with a diagnosis or history of HIT who were treated with bivalirudin between January 1, 2004, and March 31, 2007. Measurements and Main Results . Patients had a mean ± SD age of 50 ± 16 years and weighed 80 ± 20 kg; 62% were male, 73% were Caucasian, and 95% were treated in the intensive care unit. Patients were divided into three renal function groups for assessment of bivalirudin dosing requirements: creatinine clearance (Cl cr ) greater than 60 ml/minute (12 patients, group 1); Cl cr 30–60 ml/minute (11 patients, group 2); and Cl cr lower than 30 ml/minute or receiving continuous renal replacement therapy ([RRT] 14 patients, group 3). Except for renal function, baseline demographic characteristics were similar among groups. A total of 19 (51%) of the 37 patients achieved goal activated partial thromboplastin time (aPTT) with initial mean ± SD bivalirudin doses of 0.14 ± 0.04 (median 0.15), 0.1 ± 0.07 (median 0.08), and 0.05 ± 0.05 (median 0.05) mg/kg/hour in groups 1, 2, and 3, respectively. Doses remained similar over the study period and were 0.13 ± 0.04 (median 0.15), 0.1 ± 0.06 (median 0.1), and 0.04 ± 0.02 (median 0.03) mg/kg/hour for groups 1, 2, and 3, respectively. The mean ± SD aPTT value after achieving goal range was 64 ± 9 seconds (all patients). Bivalirudin dosing requirements correlated with Cl cr (r 2 = 0.37, p<0.0001). Therapy duration was a mean ± SD of 11 ± 13 days (median 7 days). Systemic thrombosis and bleeding while receiving bivalirudin were also evaluated. Thrombosis occurred in one patient; clinically significant bleeding occurred in two patients. Conclusion . Bivalirudin dosing requirements correlated with renal function; therefore, dosage reduction is required in patients with moderate or severe renal dysfunction. Starting bivalirudin at 0.15 mg/kg/hour in patients with Cl cr greater than 60 ml/minute, 0.08‐0.1 mg/kg/hour in patients with Cl cr 30–60 ml/minute, and 0.03‐0.05 mg/kg/hour in patients with Cl cr below 30 ml/minute or receiving continuous RRT is effective at achieving goal aPTT values in most patients.