Safety of sildenafil in extremely premature infants: a phase I trial
11/2021
Journal Article
Authors:
Jackson, W.;
Gonzalez, D.;
Smith, P. B.;
Ambalavanan, N.;
Atz, A. M.;
Sokol, G. M.;
Hornik, C. D.;
Stewart, D.;
Mundakel, G.;
Poindexter, B. B.;
Ahlfeld, S. K.;
Mills, M.;
Cohen-Wolkowiez, M.;
Martz, K.;
Hornik, C. P.;
Laughon, M. M.
Volume:
42
Pagination:
31-36
Issue:
1
Journal:
J Perinatol
PMID:
34741102
URL:
https://www.ncbi.nlm.nih.gov/pubmed/34741102
DOI:
10.1038/s41372-021-01261-w
Keywords:
Humans
*Hypotension/chemically induced/drug therapy
Infant, Extremely Premature
Infant, Low Birth Weight
Infant, Newborn
*Infant, Premature, Diseases/drug therapy
Sildenafil Citrate/adverse effects
Abstract:
OBJECTIVE: To characterize the safety of sildenafil in premature infants. STUDY DESIGN: A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (cohort 2). Safety was evaluated based on adverse events (AEs), transaminase levels, and mean arterial pressure monitoring. RESULTS: Twenty-four infants in cohort 1 (n = 25) received enteral sildenafil. In cohort 2, infants received a single IV sildenafil dose of 0.25 mg/kg (n = 7) or 0.125 mg/kg (n = 2). In cohort 2, there was one serious AE related to study drug involving hypotension associated with a faster infusion rate than specified by the protocol. There were no AEs related to elevated transaminases. CONCLUSION: Sildenafil was well tolerated by the study population. Drug administration times and flush rates require careful attention to prevent infusion-related hypotension associated with faster infusions of IV sildenafil in premature infants. CLINICAL TRIAL: ClinicalTrials.gov Identifier: NCT01670136.
