Evidence map›Paper›PMID 27171763›Full record

ArticleJournal of perinatology : official journal of the California Perinatal Association2016

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

N Thakkar, D Gonzalez, M Cohen-Wolkowiez, M M Massaro, J Bernhardt, N R Zane, M M Laughon

Open access · greenAbstract read
In one paragraph

Article in Journal of perinatology : official journal of the California Perinatal Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
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  9. Neonatal Therapeutics: Considerations for Dosing.American journal of perinatology · 2019
    Review
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  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

N ThakkarDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
D GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
M Cohen-WolkowiezDepartment of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
M M MassaroDepartment of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
J BernhardtDepartment of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
N R ZaneDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
M M LaughonDepartment of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
University of North Carolina at Chapel Hill · USClinical Research Institute · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD040492 · NICHD · DUKE UNIVERSITY · PI COTTEN, CHARLES MICHAEL · 2001 to 2015
$5.4M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Use of Physiologically-Based PK/PD Models to Streamline Drug ApprovalsK23HD083465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GONZALEZ, DANIEL · 2015 to 2019
$727k
Echocardiogram to Diagnose Pulmonary Hypertension in Premature InfantsR34HL124038 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2015 to 2016
$719k
Antimicrobial pharmacokinetics and outcomes in vulnerable infantsK23HD068497 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2011 to 2015
$586k
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
FDA HHS U01 FD004858NCATS NIH HHS UL1 TR001117NHLBI NIH HHS R34 HL124038NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD068497NICHD NIH HHS K23 HD083465NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD076676NICHD NIH HHS U10 HD040492NIDDK NIH HHS HHSN267200700051CNIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

objectiveThe 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

designData 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.

resultThe 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).

conclusionThe 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.

Indexed as

Infant, Extremely PrematureBronchopulmonary DysplasiaEchocardiographyFemaleHumansHypertension, PulmonaryInfantMaleNorth CarolinaPhosphodiesterase 5 InhibitorsSildenafil CitrateVentricular Function, RightPhosphodiesterase 5 InhibitorsSildenafil Citrate

Identifiers

PMID27171763
PMCPMC5002251
OpenAlexW2380996002

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.