Sania El-Hindi
Children’s Hospital of Damascus University.
Syria
World Journal of Clinical Pediatrics
World J Clin Pediatr 2026; 15:
DOI: 10.5409/wjcp.118862
Abstract
Background: Persistent pulmonary hypertension of the newborn (PPHN) remains a challenging condition with high morbidity and mortality despite advancements in management, which implies the need to investigate new therapies. While sildenafil is the drug of choice in resource-limited centers and for patients unresponsive to inhaled nitric oxide, alternative phosphodiesterase-5 inhibitors like vardenafil may offer superior efficacy.
Aim: To assess the efficacy of vardenafil in the management of persistent pulmonary hypertension in newborns.
Methods: This randomized, double-blind, controlled, parallel clinical trial was conducted at Children’s Hospital, Damascus University. Fifty-five newborns (32 females and 23 males, < 96 hours old) with moderate to severe PPHN were allocated at a 1:2 ratio to receive 2 mg/kg/day oral sildenafil (n = 18) or 0.4 mg/kg/day oral vardenafil (n = 37). Recruitment lasted from May 2023 until September 2024. Clinical and echocardiographic findings were monitored daily from diagnosis until pulmonary pressure normalization.
Results: The vardenafil group showed more rapid improvement. Pulmonary hypertension decreased significantly in the vardenafil group after 1 and 2 days (P = 0.002 and P < 0.001 respectively). Similarly, pulmonary vascular resistance decreased significantly in the vardenafil group after 1 day and 2 days (P = 0.001 and P = 0.015 respectively). Additionally, pulmonary artery flow velocity increased more in the vardenafil group after 1 day and 2 days (P = 0.046 and P = 0.048 respectively) and respiratory distress scores improved more in the vardenafil group after 2 days and 3 days of treatment (P = 0.048 and P = 0.004 respectively). No adverse events were reported in either treatment group.
Conclusion: Vardenafil at 0.4 mg/kg/day has superior efficacy compared with sildenafil at 2 mg/kg/day in improving echocardiographic and clinical outcomes in patients with PPHN, with comparable safety profiles. These findings suggest vardenafil may be a valuable option for PPHN management.
Category
Class I. Persistent Pulmonary Hypertension of the Newborn
Medical Therapy. Efficacy or Lack of Efficacy
Medical Therapy. Adverse Effects or Lack of Adverse Effects
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes