Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit

on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Enalapril is used to treat hypertension and congestive heart failure in infants. However, enalapril is not labeled for neonates, and safety data in infants are sparse. To evaluate the safety of enalapril in young infants, we conducted a retrospective cohort study of infants who were exposed to enalapril in the first 120 days of life and were cared for in 348 neonatal intensive care units from 1997 to 2012. We determined the proportion of exposed infants who developed adverse events, including death, hypotension requiring pressors, hyperkalemia, and elevated serum creatinine. Using multivariable logistic regression, we examined risk factors for adverse events, including postnatal age at first exposure, exposure duration, gestational age group, small for gestational age status, race, sex, 5-min Apgar score, and inborn status. Of a cohort of 887,910 infants, 662 infants (0.07%) were exposed to enalapril. Among exposed infants, 142 infants (21%) suffered an adverse event. The most common adverse event was hyperkalemia (13%), followed by elevated serum creatinine (5%), hypotension (4%), and death (0.5%). Significant risk factors for adverse events included postnatal age <30 days at first exposure and longer exposure duration. This study is the largest to date examining the safety of enalapril in young term and preterm infants without significant structural cardiac disease.

Original languageEnglish (US)
Pages (from-to)155-161
Number of pages7
JournalPediatric cardiology
Volume38
Issue number1
DOIs
StatePublished - Jan 1 2017

Fingerprint

Enalapril
Neonatal Intensive Care Units
Safety
Hyperkalemia
Hypotension
Gestational Age
Creatinine
Apgar Score
Serum
Premature Infants
Heart Diseases
Cohort Studies
Heart Failure
Retrospective Studies
Age Groups
Logistic Models
Newborn Infant
Hypertension

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Cardiology and Cardiovascular Medicine

Cite this

on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee (2017). Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit. Pediatric cardiology, 38(1), 155-161. https://doi.org/10.1007/s00246-016-1496-2
on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. / Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit. In: Pediatric cardiology. 2017 ; Vol. 38, No. 1. pp. 155-161.
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on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee 2017, 'Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit', Pediatric cardiology, vol. 38, no. 1, pp. 155-161. https://doi.org/10.1007/s00246-016-1496-2

Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit. / on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

In: Pediatric cardiology, Vol. 38, No. 1, 01.01.2017, p. 155-161.

Research output: Contribution to journalArticle

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T1 - Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit

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AU - Ku, Lawrence C.

AU - Zimmerman, Kanecia

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AU - Clark, Reese H.

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AU - Berezny, Katherine Y.

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AU - Kearns, Gregory L.

AU - Laughon, Matthew M.

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on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit. Pediatric cardiology. 2017 Jan 1;38(1):155-161. https://doi.org/10.1007/s00246-016-1496-2