O-024 Outcome Research In 77 Patients With Pulmonary Arterial Hypertension Receiving Sildenafil: A Double-blind, Randomised Controlled Study

Palii, Ina; Vataman, Eleonora; Revenco, Ninel; Liviu, Maniuc; Vataman, M; Oleg, Repin

doi:10.1136/archdischild-2014-307384.93

Cited by 4 publications

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“…After the title and abstract screening and removing the duplicates, 3035 articles were eliminated, and 39 full-text articles were evaluated for eligibility. Following the full-text screening, 14 [9][10][11][12][13][14][15][16][17][18][19][20][21][22] papers met our criteria and were included in our systematic review and meta-analysis (supplementary Figure 1).…”

Section: Results: Search Resultsmentioning

confidence: 99%

Sildenafil for congenital heart diseases induced pulmonary hypertension, a meta-analysis of randomized controlled trials.

Awad

Gad

Abdelgalil

et al. 2022

Preprint

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Background: PDE5 inhibitors (PDE5-Is) manifest its effects by inhibiting the PDE5 dependent cGMP hydrolysis, thus increasing cGMP intracellularly which results in vascular smooth muscles relaxation and vasodilatation. PDE 5 inhibitors, such as sildenafil, were first prescribed for angina pectoris then for erectile dysfunction (ED). Recently, sildenafil has been proposed in congenital heart diseases (CHD) induced PAH, which constitute a huge burden on children health and can attribute to fatal complications due to the un-oxygenated blood presents in the systemic circulation. Therefore, our meta-analysis aims to further investigate the safety and efficacy of sildenafil in CHD induced PH. Methods: We searched the following electronic databases: PubMed, Cochrane CENTRAL, WOS, Embase, and Scopus from inception to April 20th, 2022. Randomized controlled trials that assess the efficacy of using sildenafil in comparison to placebo or any other vasodilator drug were eligible for inclusion. The inverse variance method was used to pool study effect estimates using random effect model. Effect sizes are provided in the form of mean difference (MD) with 95% confidence intervals (CI). Results: Our study included 14 studies with (n = 849 children) with a mean age of 7.9 months old. Sildenafil showed statistically significant decrease over placebo in mPAP and sPAP with MD -7.42 (95%CI [-13.13, -1.71], P = 0.01) and − 8.02 (95%CI [-11.16, -4.88], P < 0.0001), respectively. Sildenafil revealed a decrease in mAOP and PA/OA ratio over placebo with MD -0.34 (95%CI [-2.42, 1.73], P = 0.75) and MD -0.10 (95%CI [-0.11, -0.09], P < 0.00001), respectively. Regarding post-operative parameters, sildenafil had a statistically significant lower mechanical ventilation time, ICU stay, and hospital stay over placebo with MD -19.43 (95%CI [-31.04, -7.81], P = 0.001), MD -34.85 (95%CI [-50.84, -18.87], P < 0.00001), and MD -41.87 (95%CI [-79.41, -4.33], P = 0.03), respectively. Nevertheless, no difference in mortality rates between sildenafil and placebo with OR 0.25 (95%CI 0.05, 1.30], P = 0.10) or tadalafil with OR 1 (95%CI 0.06, 17.12], P = 1). Conclusion: Sildenafil is a well-tolerated treatment in congenital heart diseases induced pulmonary hypertension, as it has proven its efficacy not only in lowering the mPAP and sPAP, but also in reducing the ventilation time, ICU and hospital stay with no difference observed regarding mortality rates.

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Section: Results: Search Resultsmentioning

confidence: 99%

Sildenafil for congenital heart diseases induced pulmonary hypertension, a meta-analysis of randomized controlled trials.

Awad

Gad

Abdelgalil

et al. 2022

Preprint

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Phosphodiesterase 5 inhibitors for pulmonary hypertension

Barnes

Brown

Burns

et al. 2019

Cochrane Database of Systematic Reviews

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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

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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.

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O-024 Outcome Research In 77 Patients With Pulmonary Arterial Hypertension Receiving Sildenafil: A Double-blind, Randomised Controlled Study

Cited by 4 publications

References 0 publications

Sildenafil for congenital heart diseases induced pulmonary hypertension, a meta-analysis of randomized controlled trials.

Sildenafil for congenital heart diseases induced pulmonary hypertension, a meta-analysis of randomized controlled trials.

Phosphodiesterase 5 inhibitors for pulmonary hypertension

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

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