Use of combination therapy with acetaminophen and ibuprofen for closure of the patent ductus arteriosus in preterm neonates

Author(s):  
Susan Kimani ◽  
Aimann Surak ◽  
Michael Miller ◽  
Soume Bhattacharya

Abstract Objective To compare effectiveness and safety of combination therapy (acetaminophen and ibuprofen) to monotherapy (ibuprofen, indomethacin, or acetaminophen alone) in treatment of the patent ductus arteriosus (PDA) in premature neonates. Methods This was a retrospective cohort study of neonates admitted to a tertiary-level neonatal intensive care unit. Included neonates were born at <32 weeks gestation and received pharmacotherapy for PDA closure. Based on the primary therapy received, our cohort was divided into the following four groups: indomethacin alone, ibuprofen alone, acetaminophen alone, and ibuprofen and acetaminophen (in combination). Baseline characteristics, effectiveness, safety, neonatal mortality, and morbidities rates between these groups were compared. Results One hundred and forty neonates were analyzed; 17 received combination therapy, and 123 neonates received monotherapy: 22 (17.9%) ibuprofen, 29 (23.6%) acetaminophen, and 72 (58.5%) indomethacin. The PDA closure rates were 41.7% for indomethacin, 41.2% for combination therapy, 37.9% for acetaminophen, and 31.8% for ibuprofen (P=0.100). Rates of adverse effects were comparable between the groups. Conclusion The rate of ductal closure was not different between combination therapy and monotherapy. The study did not demonstrate any increased adverse effects in the combination group. Future well-designed prospective clinical trials are needed to guide clinical practice.

2020 ◽  
Vol 68 (1) ◽  
Author(s):  
Reem M. Soliman ◽  
Fatma Alzahraah Mostafa ◽  
Antoine Abdelmassih ◽  
Elham Sultan ◽  
Dalia Mosallam

Abstract Background Patent ductus arteriosus poses diagnostic and therapeutic dilemma for clinicians, diagnosis of persistent PDA, and determination of its clinical and hemodynamic significance are challenging. The aim of this study is to determine the prevalence of PDA in preterm infants admitted to our NICU, to report cardiac and respiratory complications of PDA, and to study the management strategies and their subsequent outcomes. Result Echocardiography was done for 152 preterm babies admitted to neonatal intensive care unit (NICU) on day 3 of life. Eighty-seven (57.2%) preterms had PDA; 54 (62.1%) non-hemodynamically significant PDA (non-hsPDA), and 33 (37.9%) hemodynamically significant PDA. Hemodynamically significant PDA received medical treatment (paracetamol 15 mg/kg/6 h IV for 3 days). Follow-up echocadiography was done on day 7 of life. Four babies died before echo was done on day 7. Twenty babies (68.9%) achieved closure after 1st paracetamol course. Nine babies received 2nd course paracetamol. Follow-up echo done on day 11 of life showed 4 (13.7%) babies achieved successful medical closure after 2nd paracetamol course; 5 babies failed closure and were assigned for surgical ligation. The group of non-hsPDA showed spontaneous closure after conservative treatment. Pulmonary hemorrhage was significantly higher in hsPDA group. Mortality was higher in hsPDA group than non-hsPDA group. Conclusion Echocardiographic evaluation should be done for all preterms suspected clinically of having PDA. We should not expose vulnerable population of preterm infants to medication with known side effects unnecessarily; we should limit medical closure of PDA to hsPDA. Paracetamol offers several important therapeutic advantages options being well tolerated and having more favorable side effects profile.


1986 ◽  
Vol 152 (6) ◽  
pp. 704-708 ◽  
Author(s):  
Robert L. Taylor ◽  
Frederick L. Grover ◽  
P.Kent Harman ◽  
Marilyn K. Escobedo ◽  
Rajam S. Ramamurthy ◽  
...  

2010 ◽  
Vol 86 ◽  
pp. S40
Author(s):  
Avyaz Aydogdu ◽  
Bilin Cetinkaya Cakmak ◽  
Ali Rahmi Bakiler ◽  
Defne Engur ◽  
Munevver Kaynak Turkmen

1977 ◽  
Vol 23 (6) ◽  
pp. 564-567 ◽  
Author(s):  
Sarah C. Oxnard ◽  
Edwin C. McGough ◽  
August L. Jung ◽  
Herbert D. Ruttenberg

Author(s):  
Deonne Dersch-Mills ◽  
Belal Alshaikh ◽  
Amuchou S Soraisham ◽  
Albert Akierman ◽  
Kamran Yusuf

<p><strong>ABSTRACT</strong></p><p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To compare the effectiveness and adverse effects of ibuprofen arginine, ibuprofen tromethamine, and indomethacin in the treatment of PDA.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>A total of 179 infants were included. There were no differences among groups in terms of closure after one course of treatment (37/54 [69%] with indomethacin, 42/70 [60%] with ibuprofen tromethamine, and 28/55 [51%] with ibuprofen arginine; <em>p </em>= 0.21) or surgical ligation (10/54 [19%] with indomethacin, 13/70 [19%] with ibuprofen tromethamine, and 12/55 [22%] with ibuprofen arginine; <em>p </em>= 0.88). However, there was a difference regarding use of a repeat course of treatment, ibuprofen arginine having the highest rate (8/54 [15%] with indomethacin, 18/70 [26%] with ibuprofen tromethamine, and 20/55 [36%] with ibuprofen arginine; <em>p </em>= 0.04). After adjustment for gestational age, the association between ibuprofen arginine and increased use of a repeat course of treatment remained significant. The groups did not differ with respect to adverse effects.</p><p><strong>Conclusion: </strong>These results highlight the potential for differences in effectiveness among various salt forms of injectable ibuprofen and indomethacin. Because of the small sample size and retrospective methodology, confirmation of the present results through a larger prospective study is needed.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte : </strong>Il n’y a pas sur le marché de produit injectable à base d’ibuprofène pour traiter la persistance du canal artériel (PCA) chez le nouveau-né au Canada. L’ibuprofène arginine a été utilisé auparavant dans l’établissement de santé des auteurs. En l’absence de données publiées appuyant l’utilisation de ce médicament sous forme de ce sel pour traiter la PCA chez le nouveau-né, une analyse rétrospective a été réalisée.</p><p><strong>Objectif : </strong>Comparer l’efficacité et les effets indésirables de l’ibuprofène arginine, de l’ibuprofène trométhamine et de l’indométhacine dans le traitement de la PCA.</p><p><strong>Méthodes : </strong>Cette étude de cohorte observationnelle rétrospective, au sujet de patients hospitalisés entre 2009 et 2015, incluait des nourrissons prématurés atteints d’une PCA symptomatique ayant reçu par injection au moins une dose d’indométhacine, d’ibuprofène trométhamine ou d’ibuprofène arginine. Trois paramètres d’évaluation de l’efficacité ont été analysés : la fermeture après un seul traitement, la répétition du traitement médical et la ligature chirurgicale. Les paramètres d’évaluation secondaires étaient les cas d’insuffisance rénale aiguë, d’entérocolite nécrosante et de maladie pulmonaire chronique ainsi que le temps pour atteindre l’alimentation entérale complète.</p><p><strong>Résultats : </strong>Au total, 179 nourrissons ont été admis à l’étude. Aucune différence n’a été relevée entre les groupes en ce qui touche à la fermeture après un seul traitement (37/54 [69 %] pour l’indométhacine, 42/70 [60 %] pour l’ibuprofène trométhamine et 28/55 [51 %] pour l’ibuprofène arginine; <em>p </em>= 0,21) ou à la ligature chirurgicale (10/54 [19 %] pour l’indométhacine, 13/70 [19 %] pour l’ibuprofène trométhamine et 12/55 [22 %] pour l’ibuprofène arginine; <em>p </em>= 0,88). Cependant, une différence a été observée pour ce qui est de la répétition du traitement et l’ibuprofène arginine a obtenu le taux le plus élevé (8/54 [15 %] pour l’indométhacine, 18/70 [26 %] pour l’ibuprofène trométhamine et 20/55 [36 %] pour l’ibuprofène arginine; <em>p </em>= 0,04). Après ajustement pour l’âge gestationnel, l’association entre l’utilisation de l’ibuprofène arginine et une augmentation du recours à un second traitement demeurait significative. Il n’y avait pas de différence entre les groupes en ce qui touche aux effets indésirables.</p><p><strong>Conclusion : </strong>Ces résultats soulignent la possible différence d’efficacité parmi les divers sels d’ibuprofène injectable et l’indométhacine. Cependant, en raison de la petite taille de l’échantillon et de l’emploi d’une méthodologie rétrospective, une étude prospective plus importante doit être menée pour confirmer les résultats de la présente étude.</p>


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