Oral Tadalafil in Children with Pulmonary Arterial Hypertension

Tadalafil is a selective Phosphodiesterase-
5 inhibitor that has been reported to have
vasodilatory and antiproliferative effects on the
pulmonary artery. In this study we evaluated the
safety and efficacy of oral tadalafil in children
with pulmonary arterial hypertension (PAH).
Methods: This open label study, prospective
and interventional was carried out in 25 known
patients aged 2 month–5 years in 3 medical centers
in Iran, between March 2013–Jun 2014. Tadalafil
suspension was administrated at 1 mg/kg
daily for all patients. Hemodynamic and safety
parameters were assessed at baseline and then
monthly for a total of 4 visits.
Results: 19 patients received tadalafil as initial
therapy, in all visits significant improvements
in mean pulmonary arterial pressure were
observed (p < 0.01). Of the 25 patients, 6 (24 %)
had been on sildenafil for longer than 6 months.
After transition from sildenafil to tadalafil clinical
improvement was noted (p < 0.05). Administration
of tadalafil suspension was generally
safe and well tolerated. Nausea was the most frequently
reported adverse events which occurred
in 3 patients during treatment.
Conclusions: Oral tadalafil was administered
easily and tolerated well and improved mean
pulmonary artery pressure (MPAP) in children
with PAH, which suggests that oral tadalafil may
be more effective and safer than sildenafil in the
treatment of PAH.