Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension.
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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.
Published Version (Please cite this version)10.2147/DHPS.S65571
Publication InfoDodgen, AL; & Hill, Kevin Dennis (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 http://hdl.handle.net/10161/12494.
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Associate 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.