Sildenafil for pulmonary hypertension in neonates

Sildenafil may have a beneficial effect on oxygen saturation and mortality in neonates with severe persistent pulmonary hypertension but more research is needed to establish the safety and effectiveness of the therapy.

A Cochrane review included 5 studies with a total of 166 subjects. inhaled nitric oxide were not available. There was significant reduction in mortality in the sildenafil group (RR 0.20, 95% CI 0.07 to 0.57; NNT 3, 95% CI 2 to 6; 3 studies, n=77). Physiological parameters of oxygenation (oxygenation index, PaO2) suggested a steady improvement after the first dose of sildenafil. "?>When comparing sildenafil with placebo, investigators noted significant reduction in mortality in the sildenafil alone group (three studies, 77 participants; typical RR 0.20, 95% confidence interval (CI) 0.07 to 0.56; I2 = 0% - none; typical RR -0.36, 95% CI -0.53 to -0.18; number needed to treat for an additional beneficial outcome 3, 95% CI 2 to 6; I2 = 39% - low). Trials reported no significant differences in mortality upon comparison of the sildenafil group versus the active control group (one study, 65 participants; typical RR 0.55, 95% CI 0.05 to 5.75), or when iNO was administered to both groups (one study, 24 participants; typical RR 1.27, 95% CI 0.26 to 6.28). Physiological parameters of oxygenation (oxygenation index, partial pressure of oxygen in arterial blood (PaO2)) suggested steady improvement after the first dose of sildenafil. No clinically important side effects were reported.

Comment: The quality of evidence is downgraded by imprecise results (few patients) and by study quality (unclear allocation concealment).

Ədəbiyyat

1. 11;(8):CD005494. Kelly LE, Ohlsson A, Shah PS. Sildenafil for pulmonary hypertension in neonates. Cochrane Database Syst Rev 2017;(8):CD005494.