80: Treatment of Pulmonary Arterial Hypertension Using Sildenafil in Neonates with Bronchopulmonary Dysplasia

Trottier-Boucher, Marie-Noelle; Lapointe, Anie; Malo, Josianne; Fournier, Anne; Raboisson, Marie‐Josée; Martín, B. Rojano; Moussa, Ahmed

doi:10.1093/pch/19.6.e35-78

Cited by 2 publications

(3 citation statements)

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“…Several observational studies demonstrated that infants treated with sildenafil due to BPD-induced PAH reported an improved echocardiographic diagnosis of PAH [16–20]. Moreover, Baquero et al, Vargas-Origel et al, Soliz et al, and Herrera et al studies reported oxygenation index improvement and survival without associated side effects with sildenafil use in infants with BPD-induced PAH [21–24].…”

Section: Discussionmentioning

confidence: 99%

“…The finding of the side effects, however, is are consistent with the findings from the relevant trial by Konig et al, in the extremely preterm infants. Nevertheless, case reports and observational literature studies have reported some potentially serious side effects with sildenafil, including hypotension, pulmonary hemorrhage, and cerebral hemorrhage [20, 47–49]. Sildenafil was previously linked to interference with retinal function [50–52].…”

Section: Discussionmentioning

confidence: 99%

“…Here, in a recent rat model experiment, sildenafil was suggested to have possible therapeutic potential for the prevention of BPD, attributable to its activation of the hypoxia-inducible factor signaling pathway [15]. Several cohort and case-control studies evaluated the use of sildenafil for the treatment of BPD-induced PAH in infants, where these mostly reported an improved echocardiographic diagnosis of PAH [16–20]. Also, in relation to the BPD-induced PAH in infants, four clinical trials evaluated the therapeutic effect of sildenafil [21–24].…”

Section: Introductionmentioning

confidence: 99%

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Prophylactic Sildenafil in Preterm Infants at Risk of Bronchopulmonary Dysplasia: A Pilot Randomized, Double-Blinded, Placebo-Controlled Trial

et al. 2019

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Background Bronchopulmonary dysplasia (BPD) is the need for oxygen therapy at 36 weeks postmenstrual age (PMA). Sildenafil has been shown to enhance the lung alveolarization and vascularization in newborn animal models after lung injury and has possible therapeutic potential for the prevention of BPD. Objective To perform a proof-of-concept, Phase II, pilot randomized, double-blind, clinical trial to study the efficacy of sildenafil in preventing BPD, in postnatal (< 24 h), extremely and very preterm infants. Methods This Phase II, pilot randomized, double-blind, clinical trial was conducted in the Neonatal Intensive Care Unit of Women's Wellness and Research Center, Doha, Qatar during 2012-2014. Infants of 24 0/7-29 6/7 weeks' gestation were eligible if they needed respiratory or oxygen support ≥ 25% at randomization, and if they were at a postnatal age of < 24 h at randomization. Forty preterm infants were randomly assigned to receive off-label oral sildenafil (0.5 mg/kg every 6 h) or a placebo solution, for one week. The primary endpoints were the incidence of BPD and death at 36 weeks PMA, and the side effects. Secondary outcomes included the incidence of BPD and the respiratory support at day 28 of life, duration of oxygen use, fraction of inspired oxygen use at 36 weeks and 28 days of life, duration of hospitalization, and the incidence of significant retinopathy of prematurity, severe intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, patent ductus arteriosus, and late sepsis. Results No significant differences were observed between the sildenafil and placebo study groups in mortality at 36 weeks PMA (10% vs 20%, p = 1), respiratory support at 36 weeks (30% vs 25%, p = 0.57), and side effects (0% vs 0%). For all other secondary outcomes, no significant differences were detected. Conclusions While not associated with side effects, off-label oral sildenafil did not demonstrate benefits in the prevention of BPD or death in the extreme and very preterm infants. Future studies of dosing and efficacy that target different regimens of sildenafil are warranted before sildenafil is recommended for the prevention of BPD.

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Section: Discussionmentioning

confidence: 99%