Evidence summary
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Neonates with pulmonary hypertension
Shah et al9 performed a systematic review on sildenafil compared with placebo or other pulmonary vasodilators, irrespective of dose, route and duration of administration, in neonates with PPHN. Three eligible trials that enrolled 77 infants were identified. The methodological quality of the studies indicated low-moderate risk of bias. All studies were performed in resource-limited settings where iNO and high frequency ventilation were not available at the time of study. There was a significant reduction in mortality in the sildenafil group (typical RR 0.20, 95% CI 0.07 to 0.57; typical RD -0.38, 95% CI -0.60 to -0.16; Number needed to treat to benefit 3, 95% CI 2 to 6). Physiological parameters of oxygenation (oxygenation index, PaO2) suggested a steady improvement after the first dose of sildenafil. No clinically important side effects were identified. Sildenafil in the treatment of PPHN has significant potential especially in resource limited settings (LOEI, GOR B).
The European Paediatric Pulmonary Vascular Disease Network’s consensus statement 2016: Oral sildenafil should be considered for treatment of PPHN and PH in BPD, especially if iNO is not available (LOE IIa GOR B). Intravenous sildenafil may be considered for treatment of PH, including PPHN, in critically ill patients, especially in those with an unsatisfactory response to iNO (LOE IIb GOR B).4,5
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