Evidence map›Paper›PMID 28784200›Full record

ArticleCardiology in the young2018

Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants.

Christoph P Hornik, Nikolas J Onufrak, P Brian Smith, Michael Cohen-Wolkowiez, Matthew M Laughon, Reese H Clark, Daniel Gonzalez

Abstract read
In one paragraph

Article in Cardiology in the young, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 41% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
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 3 institutions in 1 country.

Christoph P Hornik1Department of Pediatrics,Duke Clinical Research Institute,Duke University,Durham,North Carolina,United States of America.
Nikolas J Onufrak2Eshelman School of Pharmacy,Division of Pharmacotherapy and Experimental Therapeutics,The University of North Carolina at Chapel Hill,Chapel Hill,North Carolina,United States of America.
P Brian Smith1Department of Pediatrics,Duke Clinical Research Institute,Duke University,Durham,North Carolina,United States of America.
Michael Cohen-Wolkowiez1Department of Pediatrics,Duke Clinical Research Institute,Duke University,Durham,North Carolina,United States of America.
Matthew M Laughon3Department of Pediatrics,Division of Neonatology,The University of North Carolina at Chapel Hill,Chapel Hill,North Carolina,United States of America.
Reese H Clark4Pediatrix-Obstetrix Center for Research and Education,Sunrise,Florida,United States of America.
Daniel Gonzalez2Eshelman School of Pharmacy,Division of Pharmacotherapy and Experimental Therapeutics,The University of North Carolina at Chapel Hill,Chapel Hill,North Carolina,United States of America.
University of North Carolina at Chapel Hill · USClinical Research Institute · USDuke University · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
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
Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary BypassK23HD090239 · NICHD · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH · 2017 to 2020
$646k
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
North Carolina Translational & Clinical Sciences Institute (NC TraCS)TL1TR001110 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$489k
PATIENT SAFETY RESEARCH DURING NEONATAL CARE (R21)R21HD080606 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2015 to 2016
$457k
FDA HHS R18 FD005292FDA HHS U01 FD004858NCATS NIH HHS TL1 TR001110NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1 TR002489NHLBI 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 K23 HD090239NICHD NIH HHS R01 HD076676NICHD NIH HHS R21 HD080606NIDDK NIH HHS HHSN267200700051C
6 · The paper itself

Abstract

backgroundThe relationship between sildenafil dosing, exposure, and systemic hypotension in infants is incompletely understood.

objectivesThe aim of this study was to characterise the relationship between predicted sildenafil exposure and hypotension in hospitalised infants.

methodsWe extracted information on sildenafil dosing and clinical characteristics from electronic health records of 348 neonatal ICUs from 1997 to 2013, and we predicted drug exposure using a population pharmacokinetic model.

resultsWe identified 232 infants receiving sildenafil at a median dose of 3.2 mg/kg/day (2.0, 6.0). The median steady-state area under the concentration-time curve over 24 hours (AUC24,SS) and maximum concentration of sildenafil (Cmax,SS,SIL) were 712 ng×hour/ml (401, 1561) and 129 ng/ml (69, 293), respectively. Systemic hypotension occurred in 9% of the cohort. In multivariable analysis, neither dosing nor exposure were associated with systemic hypotension: odds ratio=0.96 (95% confidence interval: 0.81, 1.14) for sildenafil dose; 0.87 (0.59, 1.28) for AUC24,SS; 1.19 (0.78, 1.82) for Cmax,SS,SIL.

conclusionsWe found no association between sildenafil dosing or exposure with systemic hypotension. Continued assessment of sildenafil's safety profile in infants is warranted.

Indexed as

Administration, OralCohort StudiesFemaleHumansHypertension, PulmonaryHypotensionInfantInfant, NewbornMaleMultivariate AnalysisPhosphodiesterase 5 InhibitorsRegression AnalysisSildenafil CitratePhosphodiesterase 5 InhibitorsSildenafil CitrateDosingexposureinfantsildenafilsystemic hypotension

Identifiers

PMID28784200
PMCPMC5720916
OpenAlexW2742533499

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.