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Ibuprofen or Indomethacin for PDA
B-H Su, H-C Lin, H-Y Chiu, H-Y Hsieh, H-H Chen, Y-C Tsai. Comparison of ibuprofen and indomethacin for early targeted treatment of patent ductus arteriosus in extremely premature infants: a randomized controlled trial. Arch. Dis. Child. Fetal Neonatal Ed. 2008;93;94-99 [Full text] [PDF]
Methods: 119 infants (gestational age ≤ 28 weeks) with respiratory distress syndrome and PDA confirmed by echocardiography were randomly assigned to receive either indomethacin (0.2 mg/kg) or ibuprofen (10 mg/kg), starting at <24 hours of life, followed by half these first doses within 48 hours at 24-hour intervals if indicated by echocardiographic PDA flow pattern.
Results: The PDA closure rate and the doses of drug (mean (SD)) were similar in both groups: 53/60 (88.3%) and 1.9 (1.5) mg/kg in infants given ibuprofen, and 52/59 (88.1%) and 1.9 (1.7) mg/kg in infants given indomethacin.
No significant difference was found in the numbers of infants requiring surgical ligation, and the levels of post treatment serum creatinine and urea nitrogen between the two groups. Although not significantly different, more infants (9/59 (15.3%)) treated with indomethacin tended to develop oliguria (<1 ml/kg/h) than those treated with ibuprofen (4/60 (6.7%)). There were no significant differences in side effects or complications between the two groups.
Conclusions: Ibuprofen is as effective as indomethacin for the early-targeted PDA treatment in extremely premature infants, without increasing the incidence of complications. When the echocardiographic PDA flow pattern was used as a guide for PDA treatment, fewer doses of drugs were needed to achieve acceptable closing rates.
Comment: This is a well-designed randomized controlled trial, with the limitation of the relatively small sample size. Ibuprofen is as effective as indomethacin in closing a PDA with fewer renal and gastrointestinal side effects. There is a concern regarding the development of pulmonary hypertension in those infants who received ibuprofen for PDA prophylaxis as well as PDA treatment (Ohlsson A, Walia R, Shah S. Cochrane Database 2008, Issue 1. Art. No.: CD003481. DOI). This complication was not mentioned in this study. The idea of early targeted treatment of PDA in extremely premature infants guided by echocardiographic PDA flow pattern sounds great, and appears to be superior to both PDA prophylaxis and rescue therapy provided that the facility to do an echocardiography is readily available and the neonatologist is capable of performing it with confidence. Otherwise it is not practical. AMAO.
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