Key result
Paracetamol and ibuprofen are equally effective and safe for the closure of patent ductus arteriosus in premature newborns, with paracetamol showing a potentially lower risk of acute kidney injury and gastrointestinal bleeding.
Why the study?
The comparative efficacy and safety between ibuprofen and acetaminophen needed to be determined to guide the rational choice of drug therapy for patent ductus arteriosus closure.
Does paracetamol improve efficacy and safety compared to ibuprofen for the closure of patent ductus arteriosus in premature newborns?
Systematic Review (n=781)
Does paracetamol improve efficacy and safety compared to ibuprofen for the closure of patent ductus arteriosus in premature newborns?
Paracetamol is an equally effective and potentially safer alternative to ibuprofen for the pharmacological closure of patent ductus arteriosus in premature newborns.
Supports paracetamol as alternative to ibuprofen for preterm PDA closure; confirms equivalence in 8 RCTs.
Closure of the ductus arteriosus (DA) using cyclooxygenase (COX) inhibitors is considered the first-line treatment for hemodynamically significant patent ductus arteriosus (PDA). Physiologically, prostaglandins have a recognized role in PDA. Admittedly, the comparative efficacy and safety between ibuprofen and acetaminophen need to be determined for rational choice of drug therapy for closure of the DA in clinical protocols. This study aims to present the aspects of the efficacy and therapeutic safety of paracetamol versus ibuprofen in the treatment of PDA in premature newborns. A systematic review of the literature was carried out, following the recommendations of the PRISMA protocol, using the Medline, Pubmed, LILACS, and SciELO databases. Studies from the last 10 years (2013-2023) that analyzed the efficacy and/or safety of acetaminophen compared to ibuprofen in newborns diagnosed with PDA were included. Eight randomized clinical trials (RCTs) were selected for analysis, resulting in a sample size of 781 newborns with PDA treated with acetaminophen or ibuprofen. The efficacy of acetaminophen for DA closure is comparable to ibuprofen. There is no statistically significant difference in the incidence of related adverse effects between the two drugs in most studies. There is equivalence in the efficacy and safety of ibuprofen and acetaminophen to promote closure of the DA in premature newborns with hsPDA.
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Silva et al. (2024) conducted a systematic review in Patent Ductus Arteriosus (n=781). Paracetamol vs. Ibuprofen was evaluated on Closure of patent ductus arteriosus. Paracetamol and ibuprofen are equally effective and safe for the closure of patent ductus arteriosus in premature newborns, with paracetamol showing a potentially lower risk of acute kidney injury and gastrointestinal bleeding.
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