Comparative effectiveness of drugs used to constrict the patent ductus arteriosus

a secondary analysis of the PDA-TOLERATE trial (NCT01958320)

Melissa Liebowitz, Joseph Kaempf, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Andrea Wickremasinghe, Lawrence Dong, Denise C. Hassinger, Susan W Aucott, Madoka Hayashi, Anne Marie Heuchan, William A. Carey, Matthew Derrick, Ilene Sue Wolf & 6 others Amy Kimball, Meera Sankar, Tina Leone, Jorge Perez, Arturo Serize, Ronald I. Clyman

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks. Methods: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants). Results: Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05–5.01)), followed by ibuprofen = 2.03 (1.05–3.91), and acetaminophen = 1.33 (0.55–3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)). Conclusion: Indomethacin was more effective than acetaminophen in producing ductus constriction.

Original languageEnglish (US)
Pages (from-to)599-607
Number of pages9
JournalJournal of Perinatology
Volume39
Issue number5
DOIs
StatePublished - May 1 2019

Fingerprint

Patent Ductus Arteriosus
Acetaminophen
Indomethacin
Constriction
Pharmaceutical Preparations
Ibuprofen
Newborn Infant
Therapeutics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

Cite this

Comparative effectiveness of drugs used to constrict the patent ductus arteriosus : a secondary analysis of the PDA-TOLERATE trial (NCT01958320). / Liebowitz, Melissa; Kaempf, Joseph; Erdeve, Omer; Bulbul, Ali; Håkansson, Stellan; Lindqvist, Johanna; Farooqi, Aijaz; Katheria, Anup; Sauberan, Jason; Singh, Jaideep; Nelson, Kelly; Wickremasinghe, Andrea; Dong, Lawrence; Hassinger, Denise C.; Aucott, Susan W; Hayashi, Madoka; Heuchan, Anne Marie; Carey, William A.; Derrick, Matthew; Wolf, Ilene Sue; Kimball, Amy; Sankar, Meera; Leone, Tina; Perez, Jorge; Serize, Arturo; Clyman, Ronald I.

In: Journal of Perinatology, Vol. 39, No. 5, 01.05.2019, p. 599-607.

Research output: Contribution to journalArticle

Liebowitz, M, Kaempf, J, Erdeve, O, Bulbul, A, Håkansson, S, Lindqvist, J, Farooqi, A, Katheria, A, Sauberan, J, Singh, J, Nelson, K, Wickremasinghe, A, Dong, L, Hassinger, DC, Aucott, SW, Hayashi, M, Heuchan, AM, Carey, WA, Derrick, M, Wolf, IS, Kimball, A, Sankar, M, Leone, T, Perez, J, Serize, A & Clyman, RI 2019, 'Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320)', Journal of Perinatology, vol. 39, no. 5, pp. 599-607. https://doi.org/10.1038/s41372-019-0347-4
Liebowitz, Melissa ; Kaempf, Joseph ; Erdeve, Omer ; Bulbul, Ali ; Håkansson, Stellan ; Lindqvist, Johanna ; Farooqi, Aijaz ; Katheria, Anup ; Sauberan, Jason ; Singh, Jaideep ; Nelson, Kelly ; Wickremasinghe, Andrea ; Dong, Lawrence ; Hassinger, Denise C. ; Aucott, Susan W ; Hayashi, Madoka ; Heuchan, Anne Marie ; Carey, William A. ; Derrick, Matthew ; Wolf, Ilene Sue ; Kimball, Amy ; Sankar, Meera ; Leone, Tina ; Perez, Jorge ; Serize, Arturo ; Clyman, Ronald I. / Comparative effectiveness of drugs used to constrict the patent ductus arteriosus : a secondary analysis of the PDA-TOLERATE trial (NCT01958320). In: Journal of Perinatology. 2019 ; Vol. 39, No. 5. pp. 599-607.
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abstract = "Objective: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks. Methods: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants). Results: Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95{\%} CI) = 3.21 (2.05–5.01)), followed by ibuprofen = 2.03 (1.05–3.91), and acetaminophen = 1.33 (0.55–3.24). The initial rate of acetaminophen-induced constriction was 27{\%}. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60{\%} (similar to the rate in infants receiving indomethacin-alone (62{\%})). Conclusion: Indomethacin was more effective than acetaminophen in producing ductus constriction.",
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T2 - a secondary analysis of the PDA-TOLERATE trial (NCT01958320)

AU - Liebowitz, Melissa

AU - Kaempf, Joseph

AU - Erdeve, Omer

AU - Bulbul, Ali

AU - Håkansson, Stellan

AU - Lindqvist, Johanna

AU - Farooqi, Aijaz

AU - Katheria, Anup

AU - Sauberan, Jason

AU - Singh, Jaideep

AU - Nelson, Kelly

AU - Wickremasinghe, Andrea

AU - Dong, Lawrence

AU - Hassinger, Denise C.

AU - Aucott, Susan W

AU - Hayashi, Madoka

AU - Heuchan, Anne Marie

AU - Carey, William A.

AU - Derrick, Matthew

AU - Wolf, Ilene Sue

AU - Kimball, Amy

AU - Sankar, Meera

AU - Leone, Tina

AU - Perez, Jorge

AU - Serize, Arturo

AU - Clyman, Ronald I.

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N2 - Objective: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks. Methods: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants). Results: Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05–5.01)), followed by ibuprofen = 2.03 (1.05–3.91), and acetaminophen = 1.33 (0.55–3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)). Conclusion: Indomethacin was more effective than acetaminophen in producing ductus constriction.

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