An opportunistic study evaluating pharmacokinetics of sildenafil for the treatment of pulmonary hypertension in infants.

Published

Journal Article

OBJECTIVE: The objective of this study is to assess sildenafil and N-desmethyl sildenafil (DMS) exposure in infants receiving sildenafil for the treatment of pulmonary hypertension (PH). STUDY DESIGN: Data were collected from six infants receiving sildenafil for the treatment of PH and plasma samples were collected at the time of routine laboratory blood draws. The echocardiography results were assessed for improvement in right ventricular (RV) hypertension following sildenafil treatment. RESULT: The median (range) sildenafil and DMS concentrations were 27.4 ng ml(-1) (2.6 to 434.0) and 105.5 ng ml(-1) (3.6 to 314.0), respectively. The median metabolite-to-parent ratio was higher in infants receiving co-medications that can induce cytochrome P450 (CYP) enzymes (5.2 vs 0.7). The echocardiography results showed improvement in RV hypertension for the majority of infants (5/6). CONCLUSION: The concentrations of sildenafil and DMS were within the previously observed ranges. Our results suggest that caution may be warranted when CYP-related co-medications are administered during sildenafil treatment for PH.

Full Text

Duke Authors

Cited Authors

  • Thakkar, N; Gonzalez, D; Cohen-Wolkowiez, M; Massaro, MM; Bernhardt, J; Zane, NR; Laughon, MM

Published Date

  • September 2016

Published In

Volume / Issue

  • 36 / 9

Start / End Page

  • 744 - 747

PubMed ID

  • 27171763

Pubmed Central ID

  • 27171763

Electronic International Standard Serial Number (EISSN)

  • 1476-5543

Digital Object Identifier (DOI)

  • 10.1038/jp.2016.79

Language

  • eng

Conference Location

  • United States