June 1, 2002Clinical Pharmacology & Therapeutics
Bivalirudin pharmacokinetics and pharmacodynamics: Effect of renal function, dose, and gender
Why the study?
Does renal function, dose, or gender affect the clearance and pharmacodynamics of bivalirudin?
Population
33 individuals, comprising 25 patients undergoing percutaneous coronary intervention and 8 volunteers with…
Design
Cohort
Follow-up
Up to 12 hours (duration of infusion)
Authors
Discussion
Loading...
Member takes
Implication
May warrant renal-adjusted bivalirudin dosing in PCI; extends PK data but leaves outcome effects open.
Structured PICO
Does renal function, dose, or gender affect the clearance and pharmacodynamics of bivalirudin?
P
Population
33 individuals, comprising 25 patients undergoing percutaneous coronary intervention (8 with normal renal function, 11 with mild renal impairment, 6 with moderate renal impairment) and 8 volunteers with severe renal impairment.
I
Intervention
Bivalirudin bolus (1 mg/kg) followed by infusion (2.5 mg/kg per hour for 4-6 hours then 0.5 mg/kg per hour for 4-6 hours in PCI patients; 0.5 mg/kg per hour for 10 hours in severe renal impairment volunteers).
O
Outcome
Bivalirudin plasma clearance and pharmacodynamics (activated clotting time).surrogate
Bivalirudin clearance is reduced by approximately 20-24% in patients with moderate to severe renal impairment, but remains independent of dose and gender, indicating predictable linear kinetics during PCI.
Cite This Study
Robson et al. (2002) studied this question.