Key result
High-dose oral ibuprofen in ELGANs >72 hours postnatal age resulted in comparable 24-hour exposure (AUC 509 vs 486; P=0.41) compared to standard-dose in those ≤72 hours.
Why the study?
Evidence for the optimal use of oral ibuprofen to treat persistent patent ductus arteriosus in extremely low gestational age newborns remains limited.
Does high-dose oral ibuprofen in ELGANs >72 h PNA provide comparable pharmacokinetic exposure to standard-dose oral ibuprofen in ELGANs <72 h PNA for persistent PDA?
Observational (n=23)
Does high-dose oral ibuprofen in ELGANs >72 h PNA provide comparable pharmacokinetic exposure to standard-dose oral ibuprofen in ELGANs <72 h PNA for persistent PDA?
Standard and high-dose oral ibuprofen in ELGANs with PNA <72 h and >72 h, respectively, resulted in comparable pharmacokinetic exposure.
Comparable exposure with standard early versus high-dose later regimens supports PNA-adjusted dosing; leaves open exposure-response in ELGANs.
Oral ibuprofen is the preferred pharmacotherapeutic option for treatment of a persistent patent ductus arteriosus (PDA), but evidence for its optimal use in extremely low gestational age newborns (ELGANs) remains limited. In the current study, we aimed to investigate the pharmacokinetics and exposure‐response relationship of oral ibuprofen in ELGANs of ≤72 h postnatal age (PNA) on standard (SD) versus those >72 h PNA on high‐dose (HD) regimen for closure of persistent PDA. This was a retrospective analysis of data from a previous population PK study of ELGANs with a persistent PDA treated with a SD (10–5–5 mg/kg/day, PNA <72 h) versus a HD (20–10–10 mg/kg/day, PNA >72 h) oral ibuprofen, with the primary aim of comparing degree of exposure, defined as AUC0‐24 (AUC from time 0 to 24 h). Twelve ELGANs received SD versus 11 receiving HD oral ibuprofen. The mean (SD) of exposure at 24 h (AUC0‐24 h) was 486 (128) and 509 (208) (P = .41) and at 72 h (AUC0‐72 h) was 1529 (493) and 1510 (820) (P = .94). Two (16%) ELGANs in the HD group developed severe gastrointestinal (GI) AEs and 1 (9%) in the SD had severe intraventricular hemorrhage. The use of SD and HD oral ibuprofen in ELGANs with PNA of <72 h and those >72 h, respectively, resulted in comparable exposure. The PNA‐dependent response to oral ibuprofen and exposure‐response relationship in ELGANs of higher PNA needs further investigation.
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Asif et al. (2025) conducted an observational in Patent ductus arteriosus (n=23). High-dose oral ibuprofen vs. Standard-dose oral ibuprofen (10-5-5 mg/kg/day) was evaluated on Degree of exposure, defined as AUC0-24 (p=0.41). High-dose oral ibuprofen in ELGANs >72 hours postnatal age resulted in comparable 24-hour exposure (AUC 509 vs 486; P=0.41) compared to standard-dose in those ≤72 hours.
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