A PK-PD model-based assessment of sugammadex effects on coagulation parameters
| Autor: | Annelieke C. Kruithof, Sandra A.G. Visser, Huub-Jan Kleijn, Jacobus Burggraaf, Pieter-Jan de Kam, Amy O. Johnson-Levonas, Marie-José van Lierop, Rik de Greef, Rolien Bosch |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Adolescent Pharmaceutical Science 030204 cardiovascular system & hematology Models Biological Sugammadex Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Pharmacokinetics 030202 anesthesiology medicine Humans Drug Interactions Blood Coagulation PK/PD models Aged Prothrombin time Cross-Over Studies medicine.diagnostic_test Heparin business.industry Anticoagulants Thrombosis Middle Aged Crossover study Anesthesia Pharmacodynamics Prothrombin Time Female Partial Thromboplastin Time business gamma-Cyclodextrins circulatory and respiratory physiology medicine.drug Partial thromboplastin time |
| Zdroj: | European Journal of Pharmaceutical Sciences. 84:9-17 |
| ISSN: | 0928-0987 |
| Popis: | Exposure-response analyses of sugammadex on activated partial thromboplastin time (APTT) and prothrombin time international normalized ratio (PT(INR)) were performed using data from two clinical trials in which subjects were co-treated with anti-coagulants, providing a framework to predict these responses in surgical patients on thromboprophylactic doses of low molecular weight or unfractionated heparin. Sugammadex-mediated increases in APTT and PT(INR) were described with a direct effect model, and this relationship was similar in the presence or absence of anti-coagulant therapy in either healthy volunteers or surgical patients. In surgical patients on thromboprophylactic therapy, model-based predictions showed 13.1% and 22.3% increases in respectively APTT and PT(INR) within 30min after administration of 16mg/kg sugammadex. These increases remain below thresholds seen following treatment with standard anti-coagulant therapy and were predicted to be short-lived paralleling the rapid decline in sugammadex plasma concentrations. |
| Databáze: | OpenAIRE |
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