Anticoagulation with bivalirudin during cardiopulmonary bypass in cardiac surgery

Vasquez, Julio C.; Vichiendilokkul, Anna; Mahmood, Syed; Baciewicz, Frank A.

doi:10.1016/s0003-4975(02)04125-5

Cited by 55 publications

(28 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Bivalirudin was previously known as Hirulog TM and was developed by Biogen as a synthetic form of hirudin that incorporates the binding affinity to both the catalytic active site and the anion binding exosite of thrombin [3] . Currently, bivalirudin is manufactured by Medicines Company (Parsippany, NJ, USA) at a cost of www.nature.com/aps Zhang DM et al Acta Pharmacologica Sinica npg approximately US$325 for a 250-mg vial [4] . Extensive investigations have confirmed that bivalirudin has several therapeutic features superior to UFH and LMWHs, including more predictable pharmacokinetics (PK) and pharmacodynamics (PD) behaviour, a lower proclivity to generate an immune response, and an equivalent suppression of acute ischemic events with fewer bleeding complications [5][6][7][8] .…”

Section: Introductionmentioning

confidence: 99%

Population pharmacokinetics and pharmacodynamics of bivalirudin in young healthy Chinese volunteers

et al. 2012

View full text Add to dashboard Cite

Aim:To investigate the population pharmacokinetics (PK) and pharmacodynamics (PD) of bivalirudin, a synthetic bivalent direct thrombin inhibitor, in young healthy Chinese subjects. Methods: Thirty-six young healthy volunteers were randomly assigned into 4 groups received bivalirudin 0.5 mg/kg, 0.75 mg/kg, and 1.05 mg/kg intravenous bolus, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg intravenous infusion per hour for 4 h. Blood samples were collected to measure bivalirudin plasma concentration and activated clotting time (ACT). Population PK-PD analysis was performed using the nonlinear mixed-effects model software NONMEM. The final models were validated with bootstrap and predictioncorrected visual predictive check (pcVPC) approaches. Results: The final PK model was a two-compartment model without covariates. The typical PK population values of clearance (CL), apparent distribution volume of the central-compartment (V 1 ), inter-compartmental clearance (Q) and apparent distribution volume of the peripheral compartment (V 2 ) were 0.323 L·h -1 ·kg -1 , 0.086 L/kg, 0.0957 L·h -1 ·kg -1 , and 0.0554 L/kg, respectively. The inter-individual variabilities of these parameters were 14.8%, 24.2%, fixed to 0% and 15.6%, respectively. The final PK-PD model was a sigmoid E max model without the Hill coefficient. In this model, a covariate, red blood cell count (RBC*), had a significant effect on the EC 50 value. The typical PD population values of maximum effect (E max ), EC 50 , baseline ACT value (E 0 ) and the coefficient of RBC* on EC 50 were 318 s, 2.44 mg/L, 134 s and 1.70, respectively. The inter-individual variabilities of E max , EC 50 , and E 0 were 6.80%, 46.4%, and 4.10%, respectively. Conclusion: Population PK-PD models of bivalirudin in healthy young Chinese subjects have been developed, which may provide a reference for future use of bivalirudin in China.

show abstract

Section: Introductionmentioning

confidence: 99%

Population pharmacokinetics and pharmacodynamics of bivalirudin in young healthy Chinese volunteers

et al. 2012

View full text Add to dashboard Cite

show abstract

“…42 Currently, bivalirudin is manufactured by The Medicines Company at a cost of approximately $325 USD for a 250 mg vial. 43 Bivalirudin was initially studied in an uncontrolled, multicentre, open-label dose-determination trial of 279 patients who were undergoing percutaneous transluminal coronary angioplasty (PTCA). 44 Data from this trial suggested that the higher bivalirudin dosage regimens of 1.8-2.2 mgÁkg -1 Áhr -1 infusions may be comparable with UFH during PTCA and that further study was warranted.…”

mentioning

confidence: 99%

Utilisation de la bivalirudine en chirurgie cardiaque – de l’inhibition indirecte à l’inhibition directe de la thrombine

Anand

Viles-González

Mahboobi

et al. 2010

Can J Anesth/J Can Anesth

View full text Add to dashboard Cite

Purpose Bivalirudin use for anticoagulating patients undergoing cardiac surgery, particularly those with or at risk for heparin-induced thrombocytopenia, has expanded over the past several years. The purpose of this review is to provide a summary of the following: the differences between indirect and direct thrombin inhibition, unfractionated heparin's limitations (i.e., heparin-induced thrombocytopenia), bivalirudin's pharmacology, recent cardiac surgery trials comparing bivalirudin and unfractionated heparin as anticoagulants, the growing role of bivalirudin-mediated anticoagulation for various surgical procedures, and the potential of bivalirudin-mediated vascular graft patency.

show abstract

“…The first reports of bivalirudin use during cardiac surgery were published in 2002 [87,88]. A few case reports subsequently described the use of bivalirudin anticoagulation for CPB [52,80].…”

Section: Bivalirudinmentioning

confidence: 99%

Anticoagulant therapy during cardiopulmonary bypass

Yavari

Becker

2008

J Thromb Thrombolysis

View full text Add to dashboard Cite

The prothrombotic and hemostatic-altering environment that characterizes cardiac surgery in general and cardiopulmonary bypass (CPB) in particular is unparalleled in medicine, causing, in an alarming number of patients, both thrombotic and hemorrhagic events. Fundamentally, the primary objective of anticoagulant therapy during CPB is to prevent thrombin generation and its attendant prothrombotic, proinflammatory, and vascular effects. Though anticoagulation with unfractionated heparin has been the standard of care for more than a half-century for patients undergoing cardiac surgery, inherent limitations, and an unfavorable safety profile will increasingly stimulate the investigation and development of more safe and effective therapies.

show abstract

Anticoagulation with bivalirudin during cardiopulmonary bypass in cardiac surgery

Cited by 55 publications

References 5 publications

Population pharmacokinetics and pharmacodynamics of bivalirudin in young healthy Chinese volunteers

Population pharmacokinetics and pharmacodynamics of bivalirudin in young healthy Chinese volunteers

Utilisation de la bivalirudine en chirurgie cardiaque – de l’inhibition indirecte à l’inhibition directe de la thrombine

Anticoagulant therapy during cardiopulmonary bypass

Contact Info

Product

Resources

About