title: Oral Tadalafil in Children with Pulmonary Arterial Hypertension.
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.
authors.affiliation: Pharmaceutical Sciences Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: A
authors.initials: A
authors.lastname: Shiva
authors.affiliation: Research Center for Psychiatry and Behavioral Sciences, Department of Pharmacology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Shiran
authors.affiliation: Pharmaceutical Sciences Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Rafati
authors.affiliation: Non-Communicable Pediatric Diseases Research Center, Babol University of Medical Sciences, Babol, Iran.
authors.forename: H
authors.initials: H
authors.lastname: Zamani
authors.affiliation: Non-Communicable Pediatric Diseases Research Center, Babol University of Medical Sciences, Babol, Iran.
authors.forename: K
authors.initials: K
authors.lastname: Babazadeh
authors.affiliation: Department of Pharmaceutics, Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Saeedi
authors.affiliation: Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
authors.forename: S
authors.initials: S
authors.lastname: Ala
mesh_terms: D000284:Administration, Oral; D062186:Arterial Pressure / Q000187:drug effects; D002675:Child, Preschool; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D007223:Infant; D007492:Iran; D008297:Male; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D000068677:Sildenafil Citrate / Q000627:therapeutic use; D000068581:Tadalafil / Q000627:therapeutic use*
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil; D000068677:Sildenafil Citrate