What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Pediatric Pulmonary Hypertension (PH) (n=719). Intervention: Pulmonary vasodilators (PDE5i, ERAs, PGI2) vs. Placebo or no treatment. Primary outcome: Mortality (RR 0.20, 95% CI 0.07-0.56, p=0.002).

April 23, 2021Frontiers in PharmacologyOpen Access

The Efficacy and Safety of Pulmonary Vasodilators in Pediatric Pulmonary Hypertension (PH): A Systematic Review and Meta-analysis

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Key result

Pulmonary vasodilators significantly decreased mortality (RR 0.20) compared to control treatment in pediatric patients with pulmonary hypertension.

Why the study?

The study was conducted to evaluate the efficacy and safety of pulmonary vasodilators in pediatric pulmonary hypertension patients.

Do pulmonary vasodilators reduce mortality and improve hemodynamics in pediatric patients with pulmonary hypertension?

Key Points

To assess the clinical efficacy and safety of pulmonary vasodilators in pediatric patients with pulmonary hypertension.
Systematic search of PubMed, EMBASE, and Cochrane Library conducted up to May 2020.
Identified and analyzed 15 studies covering 719 pediatric patients with pulmonary hypertension.
Conducted subgroup analyses according to specific vasodilator classes, underlying clinical conditions, and follow-up durations.
Pulmonary vasodilators significantly decreased mortality (p = 0.002), mean pulmonary artery pressure (p = 0.02), and mechanical ventilation duration (p = 0.03) while improving oxygenation index (p = 0.01), with no significant difference in adverse events compared to controls (p = 0.11, I² = 15%).
In persistent pulmonary hypertension of the newborn (PPHN), phosphodiesterase type 5 inhibitors significantly reduced mortality (p = 0.03), oxygenation index (p = 0.007), and mechanical ventilation duration (p = 0.004), while endothelin receptor antagonists improved oxygenation index (p = 0.04) and ventilation duration (p < 0.00001).
Long-term follow-up (>30 days) showed significant reductions in mortality, mean pulmonary artery pressure (p = 0.0001), pulmonary arterial/aortic pressure (p = 0.0007), mechanical ventilation duration (p = 0.004), and ICU stay (p < 0.00001).

Study Design

Type

Meta-Analysis (n=719)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Do pulmonary vasodilators reduce mortality and improve hemodynamics in pediatric patients with pulmonary hypertension?

Population

719 pediatric patients (postnatal to 18 years) diagnosed with persistent pulmonary hypertension of the newborn, postoperative pulmonary hypertension, or pediatric pulmonary arterial hypertension, followed for 24 hours to 15 months.

Intervention

Pulmonary vasodilators (phosphodiesterase type 5 inhibitors [PDE5i], endothelin receptor antagonists [ERAs], or prostacyclins [PGI2])

Comparator

Control group (placebo or active control such as MgSO4, tolazoline, or captopril)

Outcome

Mortality and adverse eventshard clinical

Main Result

Relative Risk: 0.2 (95% CI 0.07–0.56)

Absolute Risk Reduction: 3%

p-value: p=0.002

Pulmonary vasodilators significantly reduce mortality and improve respiratory and hemodynamic parameters in pediatric patients with pulmonary hypertension without increasing adverse events.

Limitations

Limited number of clinical trials and small sample sizes
Diagnosis of PH based on echocardiography in some studies, which is not the gold standard
Some included studies did not evaluate clinical endpoints such as sPAP and mPAP
Original studies lacked some key hemodynamic parameters such as PVR, CI, and CO
Potential effects of different ages on the response to pulmonary vasodilators could not be analyzed due to limited data
Small number of studies included
Small number of participants
Short duration of follow-up time
High heterogeneity in some outcomes (OI and mechanical ventilation duration)

Discussion

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Implication

Supports comparable safety across pulmonary vasodilators in pediatric PH; extends pooled evidence for individualized therapy selection.

Cite This Study

Shu et al. (2021) conducted a meta-analysis in Pediatric Pulmonary Hypertension (PH) (n=719). Pulmonary vasodilators (PDE5i, ERAs, PGI2) vs. Placebo or no treatment was evaluated on Mortality (RR 0.20, 95% CI 0.07-0.56, p=0.002). Pulmonary vasodilators significantly decreased mortality (RR 0.20) compared to control treatment in pediatric patients with pulmonary hypertension.

synapsesocial.com/papers/6a904a8b4aebf474cb341869 https://doi.org/10.3389/fphar.2021.668902

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The Efficacy and Safety of Pulmonary Vasodilators in Pediatric Pulmonary Hypertension (PH): A Systematic Review and Meta-analysis

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

The Efficacy and Safety of Pulmonary Vasodilators in Pediatric Pulmonary Hypertension (PH): A Systematic Review and Meta-analysis

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Also Consider