As with all PAH patients, the aim when treating children is to maintain or improve clinical and hemodynamic parameters and to improve long-term outcomes, including functional class and quality of life.
The dose of medicines will differ for pediatric patients and should be determined by body weight, based on results from a clinical trial in children. Ideally, formulations which are specific for pediatric patients should be used.
In July 2009, a pediatric dispersible formulation of Tracleer® (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children from two years of age has been approved in the European Union. The new quadrisect, 32mg tablet formulation of bosentan allows a convenient, accurate and more flexible dosing regimen according to low body weight.
This approval makes Tracleer® the only PAH therapy with an approved pediatric
formulation for treating children.