Safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension: a meta-analysis on the randomised controlled trials.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 33077013 · doi:10.1017/S104795112000311X
What was done
Authors conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) retrieved from MEDLINE, EMBASE, and the Cochrane Library to evaluate the safety and efficacy of sildenafil in pediatric pulmonary arterial hypertension (PAH). Two reviewers independently conducted study selection, data collection, and risk-of-bias assessments.
What was found
Fifteen RCTs encompassing 673 pediatric cases were included: - Sildenafil significantly reduced mortality relative to control (RR = 0.25, 95% CI: 0.12–0.51; p < 0.0001). - Mortality difference between high-dose and low-dose sildenafil was not statistically significant (p = 0.152). - No statistically significant differences were detected between sildenafil and control groups for mean pulmonary arterial pressure, length of hospital stay, or incidence of pulmonary hypertensive crisis. - Sildenafil was reported to reduce duration of mechanical ventilation, length of ICU stay, and inotropic support (numerical effect sizes and confidence intervals not provided in the abstract).
Why it matters
This meta-analysis provides pooled randomized trial evidence indicating a mortality reduction with sildenafil in pediatric PAH, though effects on hemodynamic parameters remain unclear.
Limits
The total pooled sample size across 15 trials is small (673 patients), indicating small individual study sizes. The abstract reports no numerical estimates or confidence intervals for hemodynamic parameters, mechanical ventilation, ICU stay, or specific adverse effects.