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Pharmacotherapy ; 39(5): 599-608, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30892733

RESUMO

Four-factor prothrombin complex concentrate (4F-PCC) has emerged as the preferred option for emergent reversal of vitamin K antagonists (VKAs); however, the optimal dosing strategy is unknown. Although several studies have attempted to determine the optimal dose of 4F-PCC using a variety of dosing regimens, no dosing strategy has been found to be superior. Many of these studies have evaluated a low, fixed dose of 4F-PCC rather than individualized dosing as recommended in product labeling. The purpose of this review was to evaluate the efficacy and safety of various fixed-dose strategies of 4F-PCC for emergent VKA reversal and to assess limitations of the existing literature. A search of the PubMed database was performed from the earliest available date through 2018 for relevant articles describing fixed-dose 4F-PCC for VKA reversal. Reference lists of relevant articles were also manually reviewed. Most currently available studies are primarily observational and heterogeneous in design. A very low fixed dose of 500 IU is likely inadequate for successful VKA reversal, but increased fixed doses of 1000-1500 IU have found some degree of success and may be considered for VKA reversal. However, many of these studies consistently identified a trend toward international normalized ratio (INR) reversal failure in patients presenting with high baseline INR values or intracranial hemorrhage, suggesting that higher 4F-PCC doses are needed in these patients. Available studies are underpowered to determine whether a dose-dependent association with thrombotic risk exists. Additional large, randomized studies are needed to determine the optimal dosing strategy and ascertain the role for fixed-dose 4F-PCC.


Assuntos
Fator IX/administração & dosagem , Fator IX/uso terapêutico , Fator VII/administração & dosagem , Fator VII/uso terapêutico , Fator X/administração & dosagem , Fator X/uso terapêutico , Hemorragia/prevenção & controle , Protrombina/administração & dosagem , Protrombina/uso terapêutico , Tromboembolia/prevenção & controle , Vitamina K/antagonistas & inibidores , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Humanos , Coeficiente Internacional Normatizado , Guias de Prática Clínica como Assunto , Resultado do Tratamento
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