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Ibuprofen for Patent Ductus
A Comparison of Ibuprofen and Indomethacin for Closure of Patent Ductus Arteriosus. Overmeire KS, Smets K, Lecoutere D, et al. N Engl J Med - to be published on 9/7/2000.
148 premature infants (24-32 weeks gestation) with RDS and hemodynamically significant PDA were randomly assigned to receive either indomethacin (0.2 mg/kg q12h x3) or ibuprofen (10 mg/kg followed by 5 mg/kg q24h x2) starting on the third day of life. The rate of ductal closure was similar with the 2 treatments (66% for indomethacin vs 70% for ibuprofen). Oliguria developed in 14 patients in the indomethacin group vs only 5 patients in the ibuprofen group (p=0.03). The babies in the indomethacin group also has lower urine output on days 3-7 (p < 0.001) and a greater increase in serum creatinine on days 4-8 (p = 0.04). There were no significant differences with respect to other side effects or complications.
Comment. This study was done in 5 NICUs in Belgium. The IV ibuprofen preparation used in not yet available in the United States. Previous studies have shown that ibuprofen is effective at causing closure of the ductus arteriosus without reducing mesenteric, renal or cerebral blood flow. This clinical trial now substantiates significantly fewer renal side effects with ibuprofen than with indomethacin. Another notable finding of this study was that NEC developed in twice as many infants in the indomethacin group. While this difference to not reach statistical significance, it suggests that mesenteric perfusion may also be better preserved with ibuprofen treatment. One possible advantage to the use of indomethacin to treat PDAs is that it also is reported to have a protective effect against IVH. There was no demonstrable difference in the incidence of IVH between groups in this study. Animal studies have shown that ibuprofen enhances cerebral blood-flow autoregulation and may have some neuroprotective effects. A larger clinical trial may be needed to assess which drug is better at preventing short-term neurologic complications such as IVH or PVL, and long-term clinical follow-up will be needed to look for differences in neurodevelopmental outcomes.
Andrew B. Kairalla MD