Perioperative sildenafil therapy for children with ventricular septal defects and associated pulmonary hypertension undergoing corrective surgery: A randomised clinical trial

Bhasin, Sidharth; Gogia, Pooja; Nair, R.; Sahoo, Tapan Kumar

doi:10.4103/ija.ija_210_17

Cited by 9 publications

(10 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…(?)(? )Sidharth (2017)20 (−)( −) ( −) ( −) ( −) S. Al (2016) 21 (þ) ( þ) ( −) ( −) ( −) Vipul (2015) 22 (þ) ( þ) ( −) ( −) ( −) Yanliang (2014) 23 (−) ( −) ( −) ( −) ( −) I Palii (2014) 24 (−) ( −) ( −) ( −) ( −) Peiravian (2013) 25 (−) ( −) ( −) ( −) ( −) El Midanya (2013) 26 (−) ( −) ( −) ( −) ( −) A. Vassalos (2011) 27 (−) ( −) ( −) ( −) ( −) Sinan (2011) 28 (−) ( −) ( −) ( −) ( −) Alain (2010) 29 (−) ( −) ( −) ( −) ( −) Arturo (2010) 30 (−) ( −) ( −) ( −) ( −) Farah (2007) 31 (?) (?)…”

unclassified

Safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension: a meta-analysis on the randomised controlled trials

Zhang

Jichen

et al. 2020

Cardiol Young

View full text Add to dashboard Cite

Background: Efficacy of sildenafil in treating paediatric pulmonary arterial hypertension is controversial. This systematic review aimed to explore the safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension (PAH) through meta-analysis. Methods and results: In this study, the electronic databases, including the Cochran Library database, EMBASE, and MEDLINE were systemically retrieved to identify the related randomised controlled trials (RCTs). Two reviewers had independently completed study selection, data collection, and assessment of the bias risk. Amongst 938 articles researched according to our retrieval strategy, 15 papers that involved 673 cases had been screened. Relative to control group, the sildenafil group had markedly reduced mortality (RR = 0.25, 95% CI: 0.12–0.51; p < 0.0001), but difference within the mortality was not statistically significant between high- and low-dose sildenafil groups (p = 0.152). Nonetheless, difference of the mean pulmonary arterial pressure between sildenafil as well as control group was of no statistical significance. Differences in the length of hospital stay and the incidences of pulmonary hypertensive crisis between children with PAH and controls were of no statistical significance. However, the summary estimate favoured that sildenafil reduced the duration of mechanical ventilation time, as well as the length of ICU stay and inotropic support. Conclusions: Sildenafil therapy reduces the mortality of PAH patients, but its effects on the haemodynamic outcomes and other clinical outcomes are still unclear.

show abstract

unclassified

Safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension: a meta-analysis on the randomised controlled trials

Zhang

Jichen

et al. 2020

Cardiol Young

View full text Add to dashboard Cite

show abstract

“…Sildenafil is well tolerated in children with idiopathic pulmonary arterial hypertension [11]. The effects of sildenafil have reported in infants and children [12][13][14][15][16][17][18]. Sildenafil increases foetal body-weight at birth [12] and intravenous sildenafil improves oxygenation in infants [13].…”

Section: Discussionmentioning

confidence: 99%

“…Sildenafil reduces N-terminal pro b-type natriuretic peptide levels in all infants with bronchopulmonary dysplasia-associated pulmonary hypertension [16]. The use of perioperative sildenafil in children has a statistically significant reduction in the mean pulmonary artery pressure without any adverse-effects [17]. Intravenous sildenafil is as effective as inhaled nitric oxide and causes pulmonary vasodilator in children with congenital heart disease [18].…”

Section: Effects Of Sildenafil In Infants and Childrenmentioning

confidence: 99%

Clinical Pharmacology of Sildenafil in Infants and Children

Pacifici¹

2021

JPPR

View full text Add to dashboard Cite

Sildenafil is a competitive and selective inhibitor of phosphodiesterase 5. Sildenafil is cleared by hepatic CYP3A (major route) and CYP2C9 (minor route) and concomitant administration of potent CYP3A inducers (e.g., bosentan) causes decreases in plasma levels of sildenafil. CYP3A4 inhibitors (erythromycin and cimetidine) inhibit sildenafil metabolism prolonging the half-life and elevating blood levels of sildenafil. Sildenafil is a pulmonary arterial vasodilator and it has been used in the treatment of persistent pulmonary hypertension. The initial oral dose is 250 to 500 µg/kg 4 times-daily in infants and the oral dose is 10 to 20 mg thrice-daily in children with a body-weight up to 20 kg or > 20 kg, respectively. Sildenafil has been found efficacy and safe in infants and children but it may induce adverse-effects. Following an oral dosing, the absorption rate constant is 0.343 h-1, and the elimination half-life is 2.41 hours in children suggesting that sildenafil is rapidly absorbed and eliminated. The interaction of sildenafil with drugs and the metabolism of sildenafil have been extensively studied. The principal routes of sildenafil metabolism are: N-demethylation, oxidation, and aliphatic dihydroxylation, and the major metabolite is N-desmethyl sildenafil. The treatment of infants and children with sildenafil has been extensively studied. Sildenafil citrate and sildenafil cross the human placenta and sildenafil migrates into the breast-milk in significant amounts. The aim of this study is to review the sildenafil dosing, efficacy and safety, effects, adverse-effects, pharmacokinetics, interaction with drugs, metabolism, treatments, and sildenafil placental transfer and migration into the breast-milk.

show abstract

“…Only two of 44 studies described pre-operative/post-operative pharmacologic management of pulmonary artery hypertension beyond those which discuss intra-operative considerations. 18,19 One of these is the study by Ademir et al in 2013. These authors compared 282 infants (median age 5 months) based on age at the time of surgery: Group 1, age 0-3 months; Group 2, age 3-6 months; and Group 3, age 6-12 months.…”

Section: Pharmacologic Managementmentioning

confidence: 99%

“…Though the authors do not document the actual number of mortalities (if any), they do indicate that there was no mortality difference between the groups. 19 Unfortunately, there were no pulmonary vascular resistance indices reported, so these cannot be contrasted between groups. Nonetheless, this study demonstrated similar results of sildenafil to those of others with mixed groups of congenital heart lesions, though the long-term effects are unclear for all.…”

Section: Pharmacologic Managementmentioning

confidence: 99%

Outcomes of infants and children undergoing surgical repair of ventricular septal defect: a review of the literature and implications for research with an emphasis on pulmonary artery hypertension

Palladino-Davis

Davis

2020

Cardiol Young

View full text Add to dashboard Cite

Background:Pulmonary vascular disease resulting from CHDs may be the most preventable cause of pulmonary artery hypertension worldwide. Many children in developing countries still do not have access to early closure of clinically significant defects, and the long-term outcomes after corrective surgery remain unclear. Focused on long-term results after isolated ventricular septal defect repair, our review sought to determine the most effective medical therapy for the pre-operative management of elevated left-to-right shunts in patients with an isolated ventricular septal defect.Methods:We identified articles specific to the surgical repair of isolated ventricular septal defects. Specific parameters included the pathophysiology and pre-operative medical management of pulmonary over-circulation and outcomes.Results:Studies most commonly focused on histologic changes to the pulmonary vasculature and levels of thromboxanes, prostaglandins, nitric oxide, endothelin, and matrix metalloproteinases. Only 2/44 studies mentioned targeted pharmacologic management to any of these systems related to ventricular septal defect repair; no study offered evidence-based guidelines to manage pulmonary over-circulation with ventricular septal defects. Most studies with long-term data indicated a measurable frequency of pulmonary artery hypertension or diminished exercise capacity late after ventricular septal defect repair.Conclusion:Long-term pulmonary vascular and respiratory changes can occur in children after ventricular septal defect repair. Research should be directed at providing an evidenced-based approach to the medical management of infants and children with ventricular septal defects (and naturally all CHDs) to minimise consequences of pulmonary artery hypertension, particularly as defect repair may occur late in underprivileged societies.

show abstract

Perioperative sildenafil therapy for children with ventricular septal defects and associated pulmonary hypertension undergoing corrective surgery: A randomised clinical trial

Cited by 9 publications

References 18 publications

Safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension: a meta-analysis on the randomised controlled trials

Safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension: a meta-analysis on the randomised controlled trials

Clinical Pharmacology of Sildenafil in Infants and Children

Outcomes of infants and children undergoing surgical repair of ventricular septal defect: a review of the literature and implications for research with an emphasis on pulmonary artery hypertension

Contact Info

Product

Resources

About