Ibuprofen Proves Equal to Indomethacin I.V.
Closure of the ductus occurred at about the same rate: 66 percent of the indomethacin-treated infants and 70 percent of ibuprofen-treated infants. Urine production decreased, however, in only 7 percent of the ibuprofen-treated infantsa significantly smaller percentage than in the other group.
Researchers studied 148 preterm infants with respiratory distress syndrome who needed mechanical ventilation and had a patent ductus arteriosus. Half the infants received three doses of i.v. indomethacin 0.2 mg/kg every 12 hours, and half received one dose of ibuprofen 10 mg/kg followed by 5 mg/kg every 24 hours for two doses.
Ibuprofen doses were compounded by reconstituting a sterile ibuprofen lysine product that was obtained from Germany. A single pharmacy prepared doses for all five study sites.
If the ductus remained open after the initial treatment and an infant still needed mechanical ventilation, the infant received three doses of indomethacin and, if necessary, underwent surgery to correct the problem. Infants who received ibuprofen were as likely to require this additional treatment as did infants who originally received indomethacin.
In the United States, an injectable form of ibuprofen is available only through a compassionate-use program sponsored by Farmacon-IL, L.L.C., of Westport, Conn. The Food and Drug Administration conferred orphan drug status to i.v. ibuprofen lysine in 1996 for the prevention and treatment of patent ductus arteriosus but has not yet granted marketing approval.
The research findings, which will be published in the Sept. 7 issue of the New England Journal of Medicine, were released early because of their potential treatment implications.