Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension.

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2015

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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.

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10.2147/DHPS.S65571

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Dodgen, Andrew L, and Kevin D Hill (2015). Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension. Drug Healthc Patient Saf, 7. pp. 175–183. 10.2147/DHPS.S65571 Retrieved from https://hdl.handle.net/10161/12494.

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Hill

Kevin Dennis Hill

Professor of Pediatrics

Clinical research including outcomes, drug and device trials, short and long term safety and efficacy of interventions and hemodynamic effects of interventions.


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