Evidence map›Paper›PMID 26386610›Full record

ArticleEarly human development2015

Comparative effectiveness and safety of indomethacin versus ibuprofen for the treatment of patent ductus arteriosus.

Brian C Gulack, Matthew M Laughon, Reese H Clark, Meera N Sankar, Christoph P Hornik, P Brian Smith

Abstract readComparative Study
In one paragraph

Article in Early human development, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Congenital Heart Disease: The State-of-the-Art on Its Pharmacological Therapeutics.Journal of cardiovascular development and disease · 2022
    Review
  6. Pharmacogenomics · 2019
    Article
  7. Observational
  8. Article
  9. Article
  10. The Link Between Infantile Colic and Migraine.Current pain and headache reports · 2016
    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

6 authors.

Brian C GulackDepartment of Surgery, Duke University School of Medicine, Durham, NC, United States.
Matthew M LaughonDepartment of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Reese H ClarkPediatrix Medical Group, Inc., Sunrise, FL, United States.
Meera N SankarPediatrix Medical Group, San Jose, CA, United States.
Christoph P HornikDepartment of Pediatrics, Duke University School of Medicine, Durham, NC, United States; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States.
P Brian SmithDepartment of Pediatrics, Duke University School of Medicine, Durham, NC, United States; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States. Electronic address: brian.smith@duke.edu.

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Duke CTSA (Composite)KL2TR001115 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, KRAFT, MONICA · 2013 to 2017
$5.1M
Duke CTSAKL2TR000437 · NCATS · DUKE UNIVERSITY · PI CALIFF, ROBERT M · 2012 to 2012
$180k
NCATS NIH HHS KL2 TR000437NCATS NIH HHS KL2 TR001115NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117
6 · The paper itself

Abstract

backgroundPatent ductus arteriosus (PDA) is common in extremely premature infants and associated with increased morbidity and mortality. Medical management of PDA uses either indomethacin or ibuprofen. Despite numerous studies, uncertainty exists as to which drug is safer or more effective; we sought to fill this knowledge gap.

methodsWe identified infants <28weeks gestational age discharged from neonatal intensive care units included in the Pediatrix Medical Group Clinical Data Warehouse between 2006 and 2012 who were treated with indomethacin or ibuprofen between postnatal days 2 and 14. Infants treated with both drugs or infants with a congenital malformation were excluded. We used multivariable logistic regression to determine the association of indomethacin versus ibuprofen on clinical outcomes.

resultsOf 6349 patients who met study criteria, 1177 (19%) received ibuprofen and 5172 (81%) received indomethacin. The median gestational age was 25weeks (interquartile range 24-26), and 2894 (46%) infants were <750g at birth. On unadjusted analysis, infants who received ibuprofen had significantly higher incidences of death prior to discharge, surgical ligation of the PDA prior to discharge, death or spontaneous intestinal perforation within 7days of therapy, death or surgical ligation of the PDA prior to discharge, and an elevated creatinine within 7days of treatment. However, on multivariable analysis, no significant differences in outcomes were observed (odds ratio for death/PDA ligation for ibuprofen vs. indomethacin=1.12 [95% CI 0.91-1.39]).

conclusionsWe observed similar effectiveness and safety profiles for indomethacin and ibuprofen in the medical management of PDA in premature infants.

Indexed as

Cardiovascular AgentsDatabases, FactualDuctus Arteriosus, PatentFemaleGestational AgeHumansIbuprofenIndomethacinInfantInfant, Extremely PrematureInfant, NewbornIntensive Care Units, NeonatalMaleTreatment OutcomeCardiovascular AgentsIbuprofenIndomethacinBronchopulmonary dysplasiaMedical managementMortalityPremature infants

Identifiers

PMID26386610
PMCPMC4662898

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Registered trials

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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.