Drug Res (Stuttg) 2016; 66(01): 7-10
DOI: 10.1055/s-0034-1395510
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Oral Tadalafil in Children with Pulmonary Arterial Hypertension

A. Shiva
1   Pharmaceutical Sciences Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
6   Department of Clinical Pharmacy, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran
,
M. Shiran
2   Research Center for Psychiatry and Behavioral Sciences, Department of Pharmacology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
,
M. Rafati
1   Pharmaceutical Sciences Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
,
H. Zamani
3   Non-Communicable Pediatric Diseases Research Center, Babol University of Medical Sciences, Babol, Iran
,
K. Babazadeh
3   Non-Communicable Pediatric Diseases Research Center, Babol University of Medical Sciences, Babol, Iran
,
M. Saeedi
4   Department of Pharmaceutics, Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
,
S. Ala
5   Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
› Author Affiliations
Further Information

Publication History

received 11 August 2014

accepted 16 October 2014

Publication Date:
22 January 2015 (online)

Abstract

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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