Efficacy and renal tolerability of ibuprofen vs. indomethacin in preterm infants with patent ductus arteriosus (original) (raw)
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European Journal of Pediatrics, 2002
Indomethacin (INDO) and, more recently, ibuprofen (IBU) have been used to treat haemodynamically significant patent ductus arteriosus (PDA) in preterm infants. Both are cyclo-oxygenase blockers, but seem to have a different influence on regional circulation. In a prospective, randomised, controlled study, we compared INDO and IBU with regard to efficacy and safety for the early non-invasive treatment of PDA. Doppler echocardiography was used to study 232 preterm infants (gestational age 23–34 weeks) with respiratory distress syndrome of whom 175 had persistent, haemodynamically significant PDA at 48–72 h of life. They were randomised to receive three intravenous doses of either INDO (0.2 mg/kg, at 12 h intervals) or IBU (a first 10 mg/kg dose followed by two doses of 5 mg/kg at 24 h intervals), recording rate of ductal closure, need for additional treatment, side-effects and clinical course. The efficacy of the pharmacological treatment was similar in the two groups (56/81, 69% INDO; 69/94, 73% IBU). Patients treated with INDO showed a significant increase in serum creatinine (89±24 versus 82±20 mmol/l, P=0.03) and a near-significant tendency for a lower fractional excretion of sodium (3±3 versus 4±2%, P=0.08); moreover, 12/81 (15%) INDO patients versus 1/94 (1%) IBU patients became oliguric (P=0.017). Conclusion: our findings confirm that, by comparison with indomethacin, ibuprofen has fewer effects on renal function in terms of urine output and fluid retention, with much the same efficacy and safety in closing patent ductus arteriosus in preterm infants with respiratory distress syndrome. In particular, no increased incidence of intracranial haemorrhage was observed after ibuprofen treatment.
Science Journal of Clinical Medicine, 2015
Background: Aim of this study was to assess the efficacy and safety of oral ibuprofen and intravenous ibuprofen for the early pharmacological treatment of patent ductus arteriosus (PDA) in preterm infants. Methods: A randomized, singleblinded, controlled study performed on premature neonates, from January 2010 to December 2012. The study enrolled 68 preterm infants with gestational age between 28-32 weeks, birth weight ≤ 2000 g, postnatal age 48-96 h, and had echocardiographically confirmed significant PDA. The preterm infants received either intravenous or oral ibuprofen randomly as an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. Serum creatinine (sCr), blood urea nitrogen (BUN) and urine output (UO) were recorded prior to start treatment, and after the course treatment. Results: 36 patients were treated with oral ibuprofen and 32 with intravenous ibuprofen in this period. After the first course treatment, the PDA closed in 30 (83.3%) of the patients assigned to the oral ibuprofen group versus 23 (71.8%) of those enrolled in the intravenous ibuprofen group (p=0.355). In the evaluation of renal tolerance, none of the patients had oliguria. The serum creatinine levels after the first and after the second treatment course did not differ significantly from the baseline for each group. Conclusions: Oral ibuprofen treatment seems to be as efficient as intravenous ibuprofen in closing PDA on the third day of life in low birth weight preterm infants and without significant changes of renal function.
The Canadian journal of hospital pharmacy
There is no injectable ibuprofen product marketed to treat patent ductus arteriosus (PDA) in newborns in Canada. The authors' institution has used ibuprofen arginine in the past. In the absence of published evidence supporting use of this salt form of ibuprofen for neonatal PDA, a retrospective analysis was undertaken. To compare the effectiveness and adverse effects of ibuprofen arginine, ibuprofen tromethamine, and indomethacin in the treatment of PDA. This retrospective observational cohort study, for patients admitted between 2009 and 2015, included preterm infants with symptomatic PDA who received at least one dose of injectable indomethacin, ibuprofen tromethamine, or ibuprofen arginine. Three effectiveness end points were analyzed: closure after one course of treatment, repeat medical treatment, and surgical ligation. The secondary end points included acute kidney injury, necrotizing enterocolitis, chronic lung disease, and time to full enteral feeding. A total of 179 inf...
The Journal of Pediatrics, 1999
Objective: To evaluate the effect of intravenous ibuprofen and indomethacin for treatment of patent ductus arteriosus (PDA) on mesenteric and renal blood flow velocity in preterm infants. Study design: Seventeen mechanically ventilated preterm infants (<33 weeks' gestation) with PDA received either 0.2 mg/kg indomethacin (n = 8) or 10 mg/kg ibuprofen (n = 9), infused over 15 minutes. Mesenteric and renal blood flow velocity were measured by using Doppler ultrasonography. Results: Indomethacin caused a significant reduction in mesenteric and renal blood flow velocity 30 minutes after drug administration; mesenteric and renal blood flow velocity did not return to the pretreatment values by 120 minutes. Ibuprofen did not alter blood flow 30 minutes after treatment, and blood flow increased 120 minutes after treatment. Mesenteric and renal blood flow velocity changes were significantly different between the 2 treatment groups.
European Journal of Pediatrics, 2016
In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P < 0.001). There was a significant reduction in platelet count and urine output (UOP) in both ibuprofen and indomethacin groups (P < 0.001). There was a significant increase in bilirubin levels in only the ibuprofen group (P = 0.003). No significant difference of hemoglobin (HB) level or liver enzymes in all groups (P > 0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001). Conclusion: Paracetamol is as effective as indomethacin and ibuprofen in closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding. What is Known: • Hemodynamically significant patent ductus arteriosus has many complications for preterm and low birth weight neonates and better to be closed. Many drugs were used for medical closure of PDA e.g. indomethacin, ibuprofen and recently paracetamol. Many studies compare safety and efficacy of paracetamol with either indomethacin or ibuprofen. What is New: • It is the first large study that compares the efficacy and side effects of the three drugs in one study.
Effect of oral Ibuprofen in ductus arteriosus closure in preterm infants
DOAJ (DOAJ: Directory of Open Access Journals), 2010
Background and Objective: Patent ductus arteriosus (PDA) is a common problem in preterm infants which can result in serious hemodynamic changes causing respiratory and cardiac morbidities if not treated in the first week of life. The treatment options available are pharmacological treatment with cyclo-oxygenase (COX) inhibitors and surgical ligation. The cyclo-oxygenase inhibitors approved for use are indomethacin and ibuprofen which have been used with different routes of administration and dosages. This study was conducted to evalute the lower and standard dose of oral ibuprofen in patent ductus arteriosus closure in preterm infants. Materials and Methods: In this clinical trial study, 44 preterm infants (<35 weeks gestational age) were randomly assigned to receive either a low dose (0.2mg/kg/dose for 3 doses, 24 hours apart) ibuprofen or a standard dose (10mg/kg/dose for the first dose, followed if needed, at 24hours interval by one or two additional doses of 5mg/kg each). These premature neonates either had clinical signs of patent ductus arteriosus or were diagnosed by echocardiography before stabilization of clinical signs. Patent ductus arteriosus closure was confirmed by echocardiography. They were under observe for drug's side effects (oliguria/anuria, GI bleeding, serum creatinin, intraventricular hemorrhage) and their clinical course was recorded. Results: The patent ductus arteriosus closure rates were the same with both doses (74% in case group vs.76% in control), 5 infants in the case group (22%) and 3 infants in the control group (14%) did not respond to the first course of therapy and needed a new course. There was a significant more rate of reducing renal output with the standard dose 33% vs. 4% (P<0.05), but the serum creatinin level was not different between two groups. One infant (4%) in the case group and 3 infants (14%) in the control group had GI bleeding. There was not any difference in intraventricular hemorrhage grading between two groups. Conclusion: This study showed that inspit of lower renal side effect, the low dose oral ibuprofen in comparison to standard dosage did not have any meaningful difference in closure of PDA in preterm infant.
Journal of Maternal-Fetal and Neonatal Medicine, 2013
Objectives: This study aims to determine whether or not treatment of preterm neonates with PDA using IV ibuprofen can impair renal function and in what range of birth weights and gestational ages the risk of major renal side-effects due to ibuprofen is highest. Methods: 134 preterm newborns with PDA were enrolled and randomized to receive either placebo or a 3-day-course (10, 5 and 5 mg/kg) of IV ibuprofen. 67 newborns (mGA: 27 +3 w and mBW: 989 g) with PDA received ibuprofen. Results: Subdividing the infants according to BW and to GA, the values of creatinine and BUN were only significantly higher than initial values at the end of the therapy in newborns with a BW ≤1000 g and/or GA ≤26 weeks. Renal impairment is greater the lower the weight and gestational age of the infant at birth. Conclusions: Ibuprofen significantly impairs renal function in preterm infants with a GA ≤26 weeks and/or in ELBW neonates, while it may be considered safe for infants with a BW >1000 g and/or GA >26 weeks. Thus, before starting therapy with IV ibuprofen, it is essential to take into account the BW and GA of newborns and the effective need for treatment from the point of view of the ratio of risks to benefits, due to its substantial renal side-effects.
Is ibuprofen superior to indomethacin for patent ductus arteriosus in Japanese preterm infants?
Pediatrics International, 2021
Background: Many clinical trials have indicated that ibuprofen (IBU) has similar effects as indomethacin (IND) on the closure of patent ductus arteriosus (PDA) with fewer adverse effects. Owing to the scarce evidence on IBU use in Japan because of its recent approval, we performed this observational study to compare the efficacy and safety of IBU with those of IND. Methods: We included infants (gestational age <30 weeks) with hemodynamically significant PDA under a prophylactic IND protocol for intraventricular hemorrhage who were treated with either IND (n=30) or IBU (n=30). We compared PDA closing effect, changes in ultrasonography findings, and adverse effects between the groups. Results: There was no significant difference in the rates of PDA closure in the first treatment course (IND vs. IBU: 46.7% vs. 50.0%, p=0.796) and surgical closure (IND vs. IBU: 20.0% vs. 20.0%, p=1.000) between the groups. Both groups showed significant oliguria (IND vs. IBU: 30.0% vs. 23.3%, p=0.559) and increased serum creatinine levels after treatment. However, an increase in serum creatinine level by >0.3 mg/dL, a criterion for acute kidney injury, was less frequent in the IBU group (35.7%) compared with that in the IND group (84.2%, p=0.004). There were no significant differences in echocardiographic changes and jaundice and hypoglycemia incidence rates between the groups. Conclusions: Except for an increase in serum creatinine levels by >0.3 mg/dL, which was less frequent with IBU, IBU had similar efficacy and safety as IND for preterm PDA. IBU and IND should be cautiously administered.
European Medical, Health and Pharmaceutical Journal, 2013
Patent ductus arteriosus (PDA) is common in very premature infants. Pharmacological closure of PDA with indomethacin, a prostaglandin inhibitor, has remained the mainstay of treatment in premature infants over the last three decades. Intravenous ibuprofen was recently shown to be as effective and to have fewer adverse reaction in preterm infants. If equally effective, then oral ibuprofen for PDA closure would have several important advantages over the intravenous route.