Evidence map›Paper›PMID 27749649›Full record

Trial reportThe Pediatric infectious disease journal2017

Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia.

Ann J Melvin, Grace Montepiedra, Lisa Aaron, William A Meyer, Hans M Spiegel, William Borkowsky, Mark J Abzug, Brookie M Best, Marilyn J Crain, Peggy R Borum and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in The Pediatric infectious disease journal, 2017. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

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

6 citing papers in PubMed.

  1. Observational
  2. Review
  3. Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022
    Article
  4. Review
  5. Review
  6. 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

15 authors.

Ann J MelvinFrom the *Division of Pediatric Infectious Disease, Department of Pediatrics, University of Washington and Seattle Children's Research Institute, Seattle, Washington; †Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts; ‡Quest Diagnostics, Baltimore, Maryland; §HJF-DAIDS, a Division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ¶Department of Pediatrics, New York University School of Medicine, New York City, New York; ‖Department of Pediatrics (Infectious Diseases), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado; **UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences and School of Medicine, University of California San Diego, San Diego, California; ††Department of Pediatrics and Microbiology, University of Alabama at Birmingham Pediatric Infectious Diseases, Birmingham, Alabama; ‡‡Department of Food Science and Human Nutrition, University of Florida, Gainesville, Florida; §§Frontier Science Inc., Buffalo, New York; ¶¶University of Southern California Maternal Child Adolescent Virology Research Lab, Los Angeles, California; ‖‖Pharmaceutical Affairs Branch Division of AIDS, NIAID, NIH, Bethesda, Maryland; and ***Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Grace Montepiedra
Lisa Aaron
William A Meyer
Hans M Spiegel
William Borkowsky
Mark J Abzug
Brookie M Best
Marilyn J Crain
Peggy R Borum
Bobbie Graham
Patricia Anthony
Katherine Shin
George K Siberry
P1063 Study Team

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
NIAID NIH HHS HHSN272200800014CNIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716
6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus (HIV)-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population.

methodsHIV-infected youth 10 to <24 years of age on stable ART with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL for ≥6 months initiated atorvastatin 10 mg once daily. Atorvastatin was increased to 20 mg if LDL-C efficacy criteria (LDL-C < 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy.

resultsTwenty-eight youth initiated atorvastatin; 7 were 10-15 years and 21 were 15-24 years. Mean baseline LDL-C was 161 mg/dL (standard deviation 19 mg/dL). Efficacy criteria were met at week 4 by 17 of 27 (63%) participants. Atorvastatin was increased to 20 mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% confidence interval: 26%, 35%) at week 4, 28% (90% confidence interval: 23%, 33%) at week 24 and 26% (90% confidence interval: 20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12 and 46% at weeks 24 and 48. Total cholesterol, non high-density lipoprotein (non-HDL)-C and apolipoprotein B decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin.

conclusionsAtorvastatin lowered total cholesterol, LDL-C, non HDL-C and apolipoprotein B in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.

Indexed as

AdolescentAdultAnti-HIV AgentsAtorvastatinChildC-Reactive ProteinFemaleHIV InfectionsHumansHyperlipidemiasMaleYoung AdultAnti-HIV AgentsAtorvastatinC-Reactive Protein

Identifiers

PMID27749649
PMCPMC5154931

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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.