Pharmacological treatment strategies for neonates with patent ductus arteriosus: a systematic review
Abstract
Background Patent ductus arteriosus (PDA) has a variety of treatment options, ranging from pharmacologic, with nonsteroidal anti-inflammatory drugs (NSAIDs) as first line therapy, to surgical ligation. However, treatment with NSAIDs is associated with severe side effects as well as many contraindications. Paracetamol is a non-classic NSAID with the prospect of fewer side effects compared to other NSAID counterparts.
Objectives To compare the efficacy and safety of paracetamol to ibuprofen or indomethacin for neonates with PDA by systematic review of the literature.
Methods Our literature search was conducted on four databases: PubMed, Scopus, Ovid, and The Cochrane Library, to find studies that compared paracetamol to ibuprofen or indomethacin in neonates with PDA. Articles were selected based on pre-set eligibility criteria. Outcomes extracted from each study included PDA closure rates as well as adverse events rates.
Results Seven randomized controlled trials (RCTs) were included in this study. Five compared paracetamol to ibuprofen and one used indomethacin as a control. The studies were of good quality, with several variations in methodology. All trials reported similar closure rates of paracetamol compared to ibuprofen or indomethacin. Three studies reported similar rates of adverse events, whereas another three reported safety profiles that favoured paracetamol over ibuprofen.
Conclusion Paracetamol has similar efficacy to ibuprofen and indomethacin with regards to rate of PDA closure following a course of treatment. Paracetamol is also reportedly relatively safe in terms of adverse events rates experienced by patients.
References
2. Benitz WE, Committee on Fetus and Newborn. Patent Ductus Arteriosus in Preterm Infants. Pediatrics [Internet]. 2016 Jan [cited 2019 Feb 18];137(1):e20153730. Available from: http://pediatrics.aappublications.org/lookup/doi/10.1542/peds.2015-3730
3. Mehta S, Younoszai A, Pietz J, Achanti B. Pharmacological closure of the patent ductus arteriosus. Images Paediatr Cardiol. 2003;5:1–15.
4. Benitz WE. Treatment of persistent patent ductus arteriosus in preterm infants: time to accept the null hypothesis? J Perinatol Off J Calif Perinat Assoc. 2010;30:241–52.
5. Pacifici GM. Clinical Pharmacology of Indomethacin in Preterm Infants: Implications in Patent Ductus Arteriosus Closure. Pediatr Drugs [Internet]. 2013 Oct [cited 2019 Feb 18];15(5):363–76. Available from: http://link.springer.com/10.1007/s40272-013-0031-7.
6. Bardanzellu F, Neroni P, Dessì A, Fanos V. Paracetamol in Patent Ductus Arteriosus Treatment: Efficacious and Safe? BioMed Res Int. 2017;2017:1438038.
7. Yang B, Gao X, Ren Y, Wang Y, Zhang Q. Oral paracetamol vs. oral ibuprofen in the treatment of symptomatic patent ductus arteriosus in premature infants: A randomized controlled trial. Exp Ther Med. 2016;12:2531–6.
8. Bagheri MM, Niknafs P, Sabsevari F, Torabi MH, Bahman Bijari B, Noroozi E, et al. Comparison of Oral Acetaminophen Versus Ibuprofen in Premature Infants With Patent Ductus Arteriosus. Iran J Pediatr. 2016;26:e3975.
9. Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009;6:e1000097.
10. Howick J, Chalmers I, Glasziou P, Greenhalgh T, Heneghan C, Alessandro Liberati, Ivan Moschetti, Bob Phillips, Hazel Thornton, Olive Goddard and Mary Hodgkinson. The Oxford Levels of Evidence 2. Oxford Centre for Evidence-Based Medicine;
11. Balachander B, Mondal N, Bhat V, Adhisivam B, Kumar M, Satheesh S, et al. Comparison of efficacy of oral paracetamol versus ibuprofen for PDA closure in preterms – a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018;1–6. DOI: 10.1080/14767058.2018.1525354.
12. Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS ONE. 2013;8:e77888.
13. Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, et al. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014;164:510-514.e1.
14. Al-lawama M, Alammori I, Abdelghani T, Badran E. Oral paracetamol versus oral ibuprofen for treatment of patent ductus arteriosus. J Int Med Res. 2018;46:811–8.
15. Dash SK, Kabra NS, Avasthi BS, Sharma SR, Padhi P, Ahmed J. Enteral paracetamol or intravenous indomethacin for closure of patent ductus arteriosus in preterm neonates: A randomized controlled trial. Indian Pediatr. 2015;52:573-8.
16. El-Mashad AE-R, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017;176:233–40.
17. Wan M, Orlu-Gul M, Legay H, Tuleu C. Blinding in pharmacological trials: the devil is in the details. Arch Dis Child. 2013;98:656–9.
Copyright (c) 2019 Oliver Emmanuel Yausep, Adhi Teguh Perma Iskandar
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Authors who publish with this journal agree to the following terms:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
Accepted 2019-09-24
Published 2019-09-24