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Anticoagulant response variability in generic versions of argatroban. Dosing Implications
Author(s) -
Thethi Indermohan,
Hoppensteadt Debra,
Cunanan Joesphine,
Lewis Bruce,
Fareed Jawed
Publication year - 2011
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.25.1_supplement.1002.16
Subject(s) - argatroban , anticoagulant , potency , dosing , pharmacology , whole blood , thrombin , chemistry , discovery and development of direct thrombin inhibitors , thrombin time , prothrombin time , medicine , coagulation , platelet , biochemistry , in vitro , partial thromboplastin time
To compare the anticoagulant responses, three generic versions of argatroban, argaron (A), Gartban (G) and slovastan (S) along with the branded product (BA) were assayed in various whole blood (ACT at a concentration of 2.5 ug/mL) and plasma clotting times (PT, APTT and TT at a concentration of 1ug/mL). In comparison to BA, the generic versions produced variable assay dependant responses in both the whole blood and plasma based assays. Moreover, the generic versions of argatroban also exhibited variations in the thrombin generation inhibition assays. When activated prothrombin complexes were used to neutralize the anticoagulant effects of argatroban, product based variations were evident. These differences were independent of the Ki value for the inhibition of purified thrombin. These results indicate that while in purified systems the potency of the generic and branded argatroban is comparable, in whole blood and plasma based systems, these drugs may differ which can be further complicated by pathologic status of patients.