Key result
Dried blood spot analysis provided valid estimations of bosentan plasma concentrations, with a geometric mean ratio of 1.10 (90% CI 1.03-1.16) for AUCτ and 1.12 (90% CI 1.04-1.20) for Cmax.
Why the study?
Does dried blood spot analysis provide comparable bosentan pharmacokinetic estimations to plasma analysis in pediatric patients with pulmonary arterial hypertension?
RCT (n=64)
Does dried blood spot analysis provide comparable bosentan pharmacokinetic estimations to plasma analysis in pediatric patients with pulmonary arterial hypertension?
Effect estimate: GMR 1.10 (95% CI 1.03-1.16)
Dried blood spot analysis is a valid and likely less invasive alternative to plasma analysis for estimating bosentan pharmacokinetics in pediatric patients with pulmonary arterial hypertension.
DBS sampling yields comparable bosentan PK estimates to plasma in pediatric PAH; confirms microsampling utility for future pediatric trials.
FUTURE-3, a phase III pediatric pharmacokinetic (PK) trial conducted to compare 2 bosentan dosing regimens in 64 patients with pulmonary arterial hypertension, offered the opportunity to compare dried blood spot (DBS)-derived data to plasma data. Bosentan PK parameters obtained with both methods were compared by the geometric mean ratio (GMR; DBS/plasma) and its 90% CI after correction for the blood-to-plasma partition ratio (0.6). Bosentan GMRs were 1.10 (1.03, 1.16) and 1.12 (1.04, 1.20) for AUCτ and Cmax, respectively. Bosentan concentrations measured by DBS were therefore good estimations of bosentan plasma concentrations. DBS can be considered a valid alternative to bosentan assessed in plasma.
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Géhin et al. (2016) conducted an RCT in pulmonary arterial hypertension (n=64). Dried blood spot (DBS) analysis vs. Plasma analysis was evaluated on Bosentan PK parameters (AUCτ and Cmax) (GMR 1.10, 95% CI 1.03-1.16). Dried blood spot analysis provided valid estimations of bosentan plasma concentrations, with a geometric mean ratio of 1.10 (90% CI 1.03-1.16) for AUCτ and 1.12 (90% CI 1.04-1.20) for Cmax.
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