[Ibuprofen versus indomethacin in the treatment of patent ductus arteriosus in preterm infants].
BACKGROUND
Persistent patent ductus arteriosus (PDA) is a common entity in preterm infants. The most commonly used pharmacological treatment to close the ductus is indomethacin but it can affect cerebral, renal and mesenteric blood flow. Ibuprofen has recently been shown to be effective in closing PDA with fewer hemodynamic effects. In this study we compared the safety and efficacy of ibuprofen and indomethacin in the treatment of PDA in preterm infants.


METHODS
A randomized trial was performed. Premature infants with symptomatic PDA confirmed by echocardiography in the first week of life and who required respiratory support were included. The patients were randomly assigned to receive either intravenous indomethacin or ibuprofen. The rate of ductal closure, need for additional treatment, complications, and clinical course were evaluated.


RESULTS
Twenty-four patients were treated with indomethacin and 23 with ibuprofen. The clinical characteristics before treatment were similar in both groups. Both treatments were effective in closing PDA (87.5% in the indomethacin group and 82.6% in the ibuprofen group). The two cohorts did not differ in the rate of reopening, need for a second pharmacologic treatment, or surgical ductal ligation. No patient in the ibuprofen group developed gastrointestinal adverse effects, but two infants in the indomethacin group had isolated bowel perforation and one had necrotizing enterocolitis. Transient renal dysfunction developed in seven patients (29%) in the indomethacin group versus two (9%) in the ibuprofen group. Transient renal insufficiency was found in one patient in the indomethacin group and in none in the ibuprofen group. The rate of other complications was similar in both groups.


CONCLUSIONS
In our trial ibuprofen was as effective as indomethacin in closing PDA. No significant differences were found in the incidence of complications but fewer renal complications and no gastrointestinal complications were found in the ibuprofen group.
Gimeno Navarro
A
A
Servicio de Neonatología, Hospital Universitario La Fe, Valencia, Spain. annagim@terra.es
Cano Sánchez
A
A
Fernández Gilino
C
C
Carrasco Moreno
J I
JI
Izquierdo Macián
I
I
Gutiérrez Laso
A
A
Morcillo Sopena
F
F
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004374:Ductus Arteriosus, Patent / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D007213:Indomethacin / Q000627:therapeutic use*; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy*; D008297:Male
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen; D007213:Indomethacin