TY - JOUR
T1 - Comparative effectiveness of drugs used to constrict the patent ductus arteriosus
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.
N1 - Publisher Copyright:
© 2019, Springer Nature America, Inc.
PY - 2019/5/1
Y1 - 2019/5/1
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.
AB - 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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U2 - 10.1038/s41372-019-0347-4
DO - 10.1038/s41372-019-0347-4
M3 - Article
C2 - 30850756
AN - SCOPUS:85062706736
SN - 0743-8346
VL - 39
SP - 599
EP - 607
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 5
ER -