Evidence map›Paper›PMID 28779238›Full record

ArticlePediatric nephrology (Berlin, Germany)2018

Effect of renal function on antihypertensive drug safety and efficacy in children.

Kevin M Watt, Debbie Avant, Jennifer Sherwin, Daniel K Benjamin, Christoph Hornik, Daniel K Benjamin, Jennifer S Li, P Brian Smith

Abstract read
In one paragraph

Article in Pediatric nephrology (Berlin, Germany), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. 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

8 authors at 3 institutions in 1 country.

Kevin M WattDepartment of Pediatrics, Duke University, Durham, NC, USA. kevin.watt@duke.edu.
Debbie AvantOffice of Pediatric Therapeutics, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jennifer SherwinDepartment of Pediatrics, Duke University, Durham, NC, USA.
Daniel K BenjaminDepartment of Economics, Clemson University, Clemson, SC, USA.
Christoph HornikDepartment of Pediatrics, Duke University, Durham, NC, USA.
Daniel K BenjaminDepartment of Pediatrics, Duke University, Durham, NC, USA.
Jennifer S LiDepartment of Pediatrics, Duke University, Durham, NC, USA.
P Brian SmithDepartment of Pediatrics, Duke University, Durham, NC, USA.
Duke University · USClinical Research Institute · USUnited States Food and Drug Administration · US

Funding

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
Pediatric Critical Care Scientist Development ProgramK12HD047349 · NICHD · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI HEATHER T. KEENAN, Kevin M Watt · 2004 to 2026
$17.0M
Renal Genomics CoreP30DK096493 · NIDDK · DUKE UNIVERSITY · PI COFFMAN, THOMAS M · 2012 to 2016
$5.9M
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemiaR01HD081044 · NICHD · DUKE UNIVERSITY · PI FISHER, BRIAN T, STEINBACH, WILLIAM J · 2014 to 2018
$3.2M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary BypassK23HD090239 · NICHD · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH · 2017 to 2020
$646k
Physiologically Based Pharmacokinetics in Critically Ill ChildrenK23HD075891 · NICHD · DUKE UNIVERSITY · PI WATT, KEVIN M · 2014 to 2018
$638k
FDA HHS R18 FD005292Intramural FDA HHS FD999999NCATS NIH HHS UL1 TR001117NIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K12 HD047349NICHD NIH HHS K23 HD075891NICHD NIH HHS K23 HD090239NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD081044NIDDK NIH HHS P30 DK096493
6 · The paper itself

Abstract

backgroundHypertension and chronic kidney disease (CKD) are common comorbidities. Guidelines recommend treating hypertension in children with CKD because it is a modifiable risk factor for subsequent cardiovascular disease. Children with CKD are frequently excluded from antihypertensive drug trials. Consequently, safety and efficacy data for antihypertensive drugs are lacking in children with CKD.

methodsWe determined the incidence of adverse events in 10 pediatric antihypertensive trials to determine the effect of renal function on antihypertensive safety and efficacy in children. These trials were submitted to the US Food and Drug Administration from 1998 to 2005. We determined the number and type of adverse events reported during the trials and compared these numbers in participants with normal renal function and those with decreased function (defined as an estimated glomerular filtration rate [eGFR] <90 mL/min/1.73 m

resultsAmong the 1,703 children in the 10 studies, 315 had decreased renal function. We observed no difference between the two cohorts in the incidence of adverse events or adverse drug reactions related to study drug. Only 5 participants, all with decreased renal function, experienced a serious adverse event; none was recorded by investigators to be study drug-related. Among treated participants, children with decreased renal function who received a high dose of study drug had a significantly larger drop in diastolic blood pressure compared with children with normal renal function.

conclusionsThese data show that antihypertensive treatment in children with renal dysfunction can be safe and efficacious, and consideration should be given to their inclusion in selected drug development programs.

Indexed as

AdolescentAntihypertensive AgentsBlood PressureChildChild, PreschoolFemaleGlomerular Filtration RateHumansHypertensionInfantKidneyMaleRenal Insufficiency, ChronicAntihypertensive AgentsAntihypertensive drugsChronic kidney diseaseHypertensionPediatrics

Identifiers

PMID28779238
PMCPMC5700840
OpenAlexW2742972206

What OpenQuestion holds

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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.