Vardenafil efficacy for the treatment of persistent pulmonary hypertension of the newborn
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, 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 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 37 participants or records.
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