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Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension
Authors Dodgen A, Hill K
Received 26 May 2015
Accepted for publication 28 September 2015
Published 15 December 2015 Volume 2015:7 Pages 175—183
DOI https://doi.org/10.2147/DHPS.S65571
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Professor Chul Ahn
Andrew L Dodgen,1 Kevin D Hill1,2
1Department of Pediatrics, Duke University Medical Center, 2Duke Clinical Research Institute, Durham, NC, USA
Abstract: Sildenafil is a phosphodiesterase type-5 inhibitor approved for treatment of pulmonary arterial hypertension (PAH) in adults. Data from pediatric trials demonstrate a similar acute safety profile to the adult population but have raised concerns regarding the safety of long-term use in children. Interpretation of these trials remains controversial with major regulatory agencies differing in their recommendations – the US Food and Drug Administration recommends against the use of sildenafil for treatment of PAH in children, while the European Medicines Agency supports its use at “low doses”. Here, we review the available pediatric data regarding dosing, acute, and long-term safety and efficacy of sildenafil for the treatment of PAH in children.
Keywords: phosphodiesterase inhibitor, pulmonary vasodilator, STARTS trials
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