Evidence map›Paper›PMID 31561960›Full record

Trial reportThe Journal of pediatrics2019

Phase I/IIa Trial of Atorvastatin in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysm.

Adriana H Tremoulet, Sonia Jain, Pei-Ni Jone, Brookie M Best, Elizabeth H Duxbury, Alessandra Franco, Beth Printz, Samuel R Dominguez, Heather Heizer, Marsha S Anderson and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05488067 (The Safety and Efficacy of Atorvastatin on Xanthoma in Alagille Syndrome), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT05488067 phase4completednot on this mapstarted 2022, after this paper: background citation

The Safety and Efficacy of Atorvastatin on Xanthoma in Alagille Syndrome

TypeinterventionalSponsorChildren's Hospital of Fudan UniversityRan2022 to 2024Enrolled15ConditionsAlagille Syndrome, Atorvastatin, XanthomaArmsatorvastatin
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Intravenous immunoglobulin for the treatment of Kawasaki disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
  7. An Update on Kawasaki Disease.Current rheumatology reports · 2024
    Review
  8. Review
  9. [Recent research on the nuclear factor-kappa B signaling pathway in cardiac injury in children with Kawasaki disease].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2023
    Review
  10. Review
  11. Mitochondrial quality control in health and cardiovascular diseases.Frontiers in cell and developmental biology · 2023
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Kawasaki Disease: an Update.Current rheumatology reports · 2020
    Review
  18. Article
  19. 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

19 authors at 3 institutions in 1 country.

Adriana H TremouletKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA. Electronic address: atremoulet@ucsd.edu.
Sonia JainBiostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.
Pei-Ni JonePediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
Brookie M BestKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.
Elizabeth H DuxburyKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.
Alessandra FrancoKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
Beth PrintzKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
Samuel R DominguezPediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
Heather HeizerPediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
Marsha S AndersonPediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
Mary P GlodéPediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
Feng HeBiostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.
Robert L PadillaKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
Chisato ShimizuKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
Emelia BaintoKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
Joan PancheriKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
Harvey J CohenDepartment of Pediatrics, Stanford University, Stanford, CA.
John C WhitinDepartment of Pediatrics, Stanford University, Stanford, CA.
Jane C BurnsKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.
University of California San Diego · USChildren's Hospital Colorado · USStanford University · US

Funding

Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
Innate Immune Activation and Endothelial Cell Dysfunction in Acute Kawasaki DiseaseR01HL140898 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BURNS, JANE C, HOFFMAN, HAROLD M · 2018 to 2022
$4.3M
Safety and Dose Optimization of High-Dose Anakinra in Kawasaki DiseaseP50HD090259 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CAPPARELLI, EDMUND VINCENT, NIZET, VICTOR · 2019 to 2020
$1.4M
Phase I and IIa trial of atorvastatin in children with acute Kawasaki diseaseR01HD081296 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TREMOULET, ADRIANA H · 2014 to 2017
$1.3M
NCATS NIH HHS UL1 TR000154NHLBI NIH HHS R01 HL140898NICHD NIH HHS P50 HD090259NICHD NIH HHS R01 HD081296
6 · The paper itself

Abstract

objectivesTo determine the safety, tolerability, pharmacokinetics, and immunomodulatory effects of a 6-week course of atorvastatin in patients with acute Kawasaki disease with coronary artery (CA) aneurysm (CAA). STUDY

designThis was a Phase I/IIa 2-center dose-escalation study of atorvastatin (0.125-0.75 mg/kg/day) in 34 patients with Kawasaki disease (aged 2-17 years) with echocardiographic evidence of CAA. We measured levels of the brain metabolite 24(S)-hydroxycholesterol (24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.

resultsA 6-week course of up to 0.75 mg/kg/day of atorvastatin was well tolerated by the 34 subjects (median age, 5.3 years; IQR, 2.6-6.4 years), with no serious adverse events attributable to the study drug. The areas under the curve for atorvastatin and its metabolite were larger in the study subjects compared with those reported in adults, suggesting a slower rate of metabolism in children. The 24-OHC levels were similar between the atorvastatin-treated subjects and matched controls.

conclusionsAtorvastatin was safe and well tolerated in our cohort of children with acute Kawasaki disease and CAA. A Phase III efficacy trial is warranted in this patient population, which may benefit from the known anti-inflammatory and immunomodulatory effects of this drug.

Indexed as

Administration, OralAdolescentAtorvastatinChildChild, PreschoolCoronary AneurysmDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMucocutaneous Lymph Node SyndromeAtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitorsatorvastatincoronary artery abnormalitiesKawasaki diseasestatin

Identifiers

PMID31561960
PMCPMC6878161
OpenAlexW2976106203

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.