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Oral Tadalafil in Children with Pulmonary Arterial Hypertension
A Shiva1, M Shiran2, M Rafati1
1Pharmaceutical Sciences Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Insights
Oral tadalafil effectively improved pulmonary arterial pressure in children with pulmonary arterial hypertension (PAH). This treatment was well-tolerated and showed promise as a safer alternative to sildenafil for pediatric PAH management.
Area of Science:
- Pediatric Cardiology
- Pharmacology
- Pulmonary Hypertension
Background:
- Pulmonary arterial hypertension (PAH) is a severe condition in children.
- Phosphodiesterase-5 (PDE5) inhibitors like tadalafil have shown potential in treating PAH.
- Limited data exists on oral tadalafil's efficacy and safety in pediatric PAH patients.
Purpose of the Study:
- To evaluate the safety and efficacy of oral tadalafil in children diagnosed with pulmonary arterial hypertension (PAH).
- To assess hemodynamic and safety parameters following tadalafil administration in pediatric PAH patients.
Main Methods:
- An open-label, prospective, interventional study involving 25 children (2 months to 5 years) with PAH.
- Tadalafil suspension administered at 1 mg/kg daily for all participants.
- Hemodynamic and safety assessments conducted monthly over 4 visits.
Main Results:
- Significant improvements in mean pulmonary arterial pressure (MPAP) were observed in patients receiving tadalafil as initial therapy (p<0.01).
- Patients transitioned from sildenafil to tadalafil showed clinical improvement (p<0.05).
- Tadalafil was generally safe and well-tolerated, with nausea being the most common adverse event (3 patients).
Conclusions:
- Oral tadalafil is easily administered and well-tolerated in children with PAH.
- Tadalafil demonstrated significant improvement in MPAP, suggesting potential efficacy in pediatric PAH.
- Oral tadalafil may offer a safer and more effective treatment option compared to sildenafil for pediatric PAH.
Objective:
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.
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