Journal
PEDIATRIC CARDIOLOGY
Volume 38, Issue 1, Pages 155-161Publisher
SPRINGER
DOI: 10.1007/s00246-016-1496-2
Keywords
Enalapril; Drug safety; Infant pharmacology; Pharmacoepidemiology
Categories
Funding
- National Institute of Child Health and Human Development [5T32GM086330-03, 5T32HD043029-13, 4K12HD043494-14, HHSN275201000003I, 1R01-HD081044-01]
- Duke Clinical and Translational Science Awards [KL2TR001115-03]
- National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) [UL1TR001117]
- NIH
- National Center for Advancing Translational Sciences of the NIH [UL1TR001117]
- Food and Drug Administration [1R18-FD005292-01]
- Cempra Pharmaceuticals [HHS0100201300009C]
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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.
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