Abstract
Purpose
Two animal studies were conducted to determine the feasibility of infusing treprostinil via a central venous catheter at an infusion rate of 0.1 mL/hour. Currently treprostinil is administered intravenously at infusion rates of approximately 1.0 to 2.0 mL/hour to patients with pulmonary arterial hypertension, which reflects standard clinical practice to ensure line patency with continuous intravenous administration via a central venous catheter.
Methods
In a pilot study three male beagle dogs were administered 50 ng/kg/min of treprostinil continuously at an infusion rate of 0.1 mL/hr via the MiniMed 407C infusion pump for 21 days. In a definitive study, six male beagle dogs were administered 50 ng/kg/min of treprostinil continuously at an infusion rate of 0.1 mL/hr via the MiniMed 407C infusion pump for 60 days. In both studies “no delivery” pump alarms were documented throughout the study in addition to pharmacokinetic data at specified time points.
Results
There were no documented occlusions in the 21-day pilot study. In the 60-day study one animal had a documented catheter occlusion after 16 days of therapy. Following re-implantation with a new catheter this animal did not have any additional occlusions for 40 days. No other animals in this study had any significant problems. In both studies, pharmacokinetic data were similar to that observed in previous animal studies evaluating treprostinil administration at the same dose and at higher infusion rates.
Conclusion
These animal data support the evaluation of administering treprostinil at a low infusion rate via the MiniMed 407C infusion pump in patients with pulmonary arterial hypertension.
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