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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-blind

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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