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Sildenafil for pulmonary hypertension complicating bronchopulmonary dysplasia

Varsha Bhatt-Mehta1, Steven M Donn

  • 1College of Pharmacy, University of Michigan Health System, Ann Arbor, MI 48109-5254, USA.

Expert Review of Clinical Pharmacology
|May 29, 2014
PubMed

Insights

Sildenafil is used for infant pulmonary hypertension, but evidence for its safety and effectiveness is lacking. The US FDA advises against its use in this population.

Area of Science:

  • Pediatric Pulmonology
  • Pharmacology
  • Neonatology

Background:

  • Sildenafil, a phosphodiesterase-5 inhibitor, is frequently prescribed for infants with bronchopulmonary dysplasia and pulmonary hypertension.
  • This usage persists despite a significant lack of robust clinical evidence supporting its safety or efficacy in this vulnerable patient group.

Discussion:

  • The clinical application of sildenafil in neonates with bronchopulmonary dysplasia-associated pulmonary hypertension is controversial.
  • Current treatment guidelines and regulatory advisories, including from the US Food and Drug Administration (FDA), recommend against its use due to insufficient data.

Key Insights:

  • There is a critical need to evaluate the safety and efficacy of sildenafil in infants with bronchopulmonary dysplasia.
  • Clinical practice patterns for sildenafil in this indication are not aligned with available evidence or regulatory recommendations.

Outlook:

  • Future research should focus on well-designed clinical trials to ascertain the true benefit-risk profile of sildenafil in pediatric pulmonary hypertension.
  • Clarifying the role of phosphodiesterase-5 inhibitors in neonatal cardiopulmonary disorders is essential for evidence-based clinical decision-making.

Keywords:
bronchopulmonary dysplasiaefficacyinfantneonatepulmonary hypertensionsafetysildenafil

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