Monday, April 20

Population Pharmacokinetics and Exposure-Safety Analysis of Furosemide in Preterm Infants

Signal observed for improved furosemide dosing guidance in preterm infants through population pharmacokinetics modeling. Evidence suggests that 2 mg/kg enteral dosing every 6 hours results in minimal risk of exceeding ototoxicity thresholds (approximately 4% of maximum concentrations >50 µg/mL), with rare occurrences of hearing loss, nephrocalcinosis, or nephrolithiasis showing no relationship to furosemide exposure. Worth noting that these findings contributed to the October 2024 FDA label update incorporating pediatric pharmacokinetic data for improved dosing recommendations.

These data contributed to the October 2024 FDA label update to include pediatric popPK data and improve dosing in preterm infants.

Relevance: Directly relevant to furosemide dosing optimization in pediatric patients, providing safety and exposure data that inform clinical use of this commonly prescribed diuretic in the practice formulary.

Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial

Signal observed for a Phase 2 randomized controlled trial investigating left ventricular hypertrophy and fibrosis regression in aortic stenosis with planned enrollment of 445 participants. The study is currently in not-yet-recruiting status and focuses on cardiac remodeling outcomes in acquired aortic stenosis.

Relevance: Limited relevance as this trial addresses acquired aortic stenosis in adults rather than the congenital heart lesions (HLHS, TOF, TGA, Fontan) that comprise the primary practice focus, though cardiac remodeling concepts may have some applicability.