Key result
Treprostinil administration in pediatric patients showed a linear dose-concentration relationship (R=0.57), with significantly lower blood concentrations per dose compared with adults.
Why the study?
The study evaluated the pharmacokinetics of intravenous and subcutaneous treprostinil in pediatric patients with pulmonary vascular disease and compared them with existing adult data from a similar cohort.
Does the pharmacokinetic profile of IV and SC treprostinil differ between pediatric patients with pulmonary vascular disease and adults, or between administration routes?
Observational (n=40)
Does the pharmacokinetic profile of IV and SC treprostinil differ between pediatric patients with pulmonary vascular disease and adults, or between administration routes?
Effect estimate: R 0.57
Pediatric patients require higher doses of treprostinil to achieve similar blood concentrations compared to adults, highlighting the need for age-specific dosing strategies in pulmonary vascular disease.
May support higher pediatric treprostinil dosing; leaves open prospective validation of age-specific regimens.
This study evaluated the pharmacokinetics of intravenous (IV) and subcutaneous (SC) treprostinil in pediatric patients with pulmonary vascular disease, and compared them with existing adult data from a similar cohort. Blood samples were collected from pediatric patients receiving steady-state IV or SC treprostinil and were assessed for plasma treprostinil concentration using liquid chromatography and tandem mass spectrometry. Forty participants, 15 receiving IV and 25 receiving SC treprostinil, were included in the analysis. Age ranged from 0.1 to 15.6 years. The median dose of treprostinil was 45.5 ng·kg·min with a range of 8-146 ng·kg·min. There was a linear relationship between treprostinil dose and plasma concentration with an R of 0.57. On average, there were higher blood concentrations per given dose of IV treprostinil compared with those per given dose of SC, but the difference was not significant. Compared with adult data, the slope of the pediatric data was similar, but the y-intercept was significantly lower. Additionally, the concentration per dose ratio was significantly higher in adults compared with children. Pediatric patients have significantly lower average blood concentrations of treprostinil per given dose compared with adults, and higher, but not significantly so, blood concentrations when treprostinil is administered IV as compared with SC administration.
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Hall et al. (2019) conducted an observational in Pulmonary vascular disease (n=40). Treprostinil (Intravenous or Subcutaneous) vs. Adult data and alternate administration route was evaluated on Plasma treprostinil concentration (R 0.57). Treprostinil administration in pediatric patients showed a linear dose-concentration relationship (R=0.57), with significantly lower blood concentrations per dose compared with adults.
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