Sildenafil and Retinopathy of Prematurity in Preterm Infants with Bronchopulmonary Dysplasia

Aboudi, David; Swaminathan, N.; Brumberg, Heather L.; Shi, Qiuhu; Friedman, Deborah; Parvez, Boriana; Krishnan, Usha

doi:10.1016/j.jpeds.2018.04.005

Cited by 10 publications

(16 citation statements)

References 42 publications

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“…[153][154][155] Infants that had received sildenafil had reduced pulmonary vascular pressures, and improvement in gas exchange with no adverse effects. [156][157][158][159] Although these early studies show that sildenafil is well tolerated, there are concerns regarding drug safety due to increased mortality when administered at higher doses in older children. 160 In addition, prenatal administration of sildenafil in the setting of intrauterine growth restriction resulted in increased mortality in the STRIDER study.…”

Section: Sildenafilmentioning

confidence: 99%

Bronchopulmonary Dysplasia: An Update of Current Pharmacologic Therapies and New Approaches

Michael

Spyropoulos

Ghanta

et al. 2018

Clin Med Insights Pediatr

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Bronchopulmonary dysplasia (BPD) remains the most prevalent long-term morbidity of surviving extremely preterm infants and is associated with significant health care utilization in infancy and beyond. Recent advances in neonatal care have resulted in improved survival of extremely low birth weight (ELBW) infants; however, the incidence of BPD has not been substantially impacted by novel interventions in this vulnerable population. The multifactorial cause of BPD requires a multi-pronged approach for prevention and treatment. New approaches in assisted ventilation, optimal nutrition, and pharmacologic interventions are currently being evaluated. The focus of this review is the current state of the evidence for pharmacotherapy in BPD. Promising future approaches in need of further study will also be reviewed.

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Section: Sildenafilmentioning

confidence: 99%

Bronchopulmonary Dysplasia: An Update of Current Pharmacologic Therapies and New Approaches

Michael

Spyropoulos

Ghanta

et al. 2018

Clin Med Insights Pediatr

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“…To date, there are no case series reporting an association between sildenafil exposure and an increased risk or worsening of ROP. Aboudi et al 11 demonstrated a concerning difference in the prevalence of ROP in infants with very low birthweights (≤1500 g) and bronchopulmonary dysplasia who were exposed to sildenafil, and their matched controls (26% (6 of 23) vs. 7% (5 of 69); OR 6.4). The mean GA of these infants was 25 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…Two retrospective case–control series have since found no association between sildenafil use in very premature neonates and ROP progression, or the need for treatment . Furthermore, Aboudi et al . did not find a statistically significant association between sildenafil treatment and worsening of ROP in infants with very low birthweights (≤1500 g).…”

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confidence: 99%

Ophthalmic findings in neonates receiving sildenafil

Dunn

Kim

Popat

et al. 2020

J Paediatrics Child Health

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Aim To determine the risk of ocular complications of sildenafil therapy in neonates. Methods Retrospective case review of neonates with persistent pulmonary hypertension of the newborn who received sildenafil therapy between 2010 and 2015 in a single, tertiary surgical neonatal intensive care unit in Australia. Ophthalmic examination findings in the neonatal intensive care unit and follow‐up were examined. Results Twenty‐seven neonates with persistent pulmonary hypertension of the newborn received sildenafil. The median gestational age (GA) was 38 weeks (range 24–41 weeks), and median birthweight was 2690 g (range 454–4270 g). Ophthalmic review was undertaken in 23 neonates, and 16 neonates were term or near‐term infants (GA 31–40 weeks). All of them had a normal initial ophthalmic examination; one child was later diagnosed with hypermetropia and another with infantile esotropia. Amongst the seven premature infants (GA 24–30 weeks), three had retinopathy of prematurity (ROP) diagnosed at the first ophthalmic review and the other four had normal initial examinations. Two patients later developed ROP, one of whom was also diagnosed with congenital motor nystagmus. All five patients diagnosed with ROP were extremely preterm (<28 weeks) with low birthweight (454–635 g). Conclusions There were no short‐term complications attributable to sildenafil therapy identified in term or near‐term neonates (GA ≥31 weeks). This cohort of neonates does not typically undergo ophthalmic review as part of the ROP screening protocol in our institution. Routine ophthalmic review of neonates on sildenafil therapy, who are not at risk of ROP, is therefore unlikely to be warranted. Further research is required to clarify the relationship between sildenafil and ROP.

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“…A cohort of term and preterm neonates exposed to sildenafil was found not to exhibit a correlation with ocular complications, and these results did not support the necessity of a routine ophthalmological examination (58)(59)(60)(61). A recent study compared a sildenafil group to a control group in preterm neonates with BPD, and found that neonates in the sildenafil group had a higher prevalence of severe retinopathy of prematurity (ROP) than the control group; however, there was no statistically significant association (62). A large multicentre trial is needed to resolve this controversy.…”

Section: Adverse Effects Of Sildenafil Use In Neonatesmentioning

confidence: 94%

Update on the use of sildenafil in neonatal pulmonary hypertension: a narrative review of the history, current administration, and future directions

Li¹,

Lv²,

Liu³

et al. 2021

Transl Pediatr

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Pulmonary hypertension (PH) is a life-threatening syndrome in neonates and has multiple and varied etiologies. However, few clinical studies have systematically evaluated the treatment regimens for this population. Phosphodiesterase (PDE) inhibitors, such as milrinone, tadalafil, dipyridamole, and sildenafil, are the most important regulators of vascular relaxation in the normal pulmonary vascular transition after birth, and these agents are widely used in the treatment of PH. Sildenafil, a representative PDE-5 inhibitor, has an important role as a single mode of therapy. However, the lack of evidence from pharmacokinetic and clinical trials has limited the emergence of standardized treatment regimens for sildenafil. There are also differing opinions among researchers regarding the best route of sildenafil administration. Due to the interindividual variability in the neonatal population, it is worth selecting the most suitable route of sildenafil administration according to the specific conditions of the neonatal population. These may be evaluated using the oxygenation index (OI), pulmonary artery pressure, mean blood pressure, and the serological index. This article reviews the clinical data on the use of sildenafil, focusing on the current and promising alternative routes of administration, which may affect subsequent clinical research in term and preterm neonates.

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Sildenafil and Retinopathy of Prematurity in Preterm Infants with Bronchopulmonary Dysplasia

Cited by 10 publications

References 42 publications

Bronchopulmonary Dysplasia: An Update of Current Pharmacologic Therapies and New Approaches

Bronchopulmonary Dysplasia: An Update of Current Pharmacologic Therapies and New Approaches

Ophthalmic findings in neonates receiving sildenafil

Update on the use of sildenafil in neonatal pulmonary hypertension: a narrative review of the history, current administration, and future directions

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