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Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320).

  • Author(s): 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
  • et al.


To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks.


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).


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%)).


Indomethacin was more effective than acetaminophen in producing ductus constriction.

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