Evidence map›Paper›PMID 20824151›Full record

Trial reportJournal of clinical lipidology

Treatment with pravastatin and fenofibrate improves atherogenic lipid profiles but not inflammatory markers in ACTG 5087.

Carl J Fichtenbaum, Tzu-Min Yeh, Scott R Evans, Judith A Aberg

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical lipidology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006412 (A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 9% 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.

NCT00006412 phase3completednot on this map

A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrolled630ConditionsHIV Infections, LipodystrophyArmsPravastatin sodium, Fenofibrate
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Rosuvastatin preserves renal function and lowers cystatin C in HIV-infected subjects on antiretroviral therapy: the SATURN-HIV trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Trial
  4. Review
  5. Article
  6. Review
  7. Association of Statin Use With Kidney Damage and Function Among HIV-Infected Men.Journal of acquired immune deficiency syndromes (1999) · 2019
    Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Carl J FichtenbaumDivision of Infectious Diseases, Department of Internal Medicine, University of Cincinnati College of Medicine, PO Box 670405, 231 Albert Sabin Way, Cincinnati, OH 45267-0405, USA. carl.fichtenbaum@uc.edu
Tzu-Min Yeh
Scott R Evans
Judith A Aberg
Harvard University · USNew York University · USUniversity of Cincinnati Medical Center · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
WOMEN'S HEALTH AGENDAU01AI025897 · NIAID · UNIVERSITY OF CINCINNATI · PI FEINBERG, JUDITH E · 1987 to 2006
$12.5M
WOMEN'S HEALTH AGENDAU01AI027665 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 1988 to 2006
$11.8M
University of Cincinnati AIDS Clinical Trials Unit- UC ACTUU01AI069513 · NIAID · UNIVERSITY OF CINCINNATI · PI FICHTENBAUM, CARL J · 2007 to 2011
$8.6M
New York University HIV/AIDS Clinical Trial UnitU01AI069532 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 2007 to 2011
$7.5M
University of Cincinnati AIDS Clinical Trials Unit- UC ACTUUM1AI069513 · NIAID · UNIVERSITY OF CINCINNATI · PI FICHTENBAUM, CARL J · 2012 to 2013
$3.2M
New York University HIV/AIDS Clinical Trial UnitUM1AI069532 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 2012 to 2014
$2.9M
NIAID NIH HHS U01 AI025897NIAID NIH HHS U01 AI027665NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069532NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069532
6 · The paper itself

Abstract

objectivesStatins and fibrates alter lipids, apolipoproteins and inflammatory markers in persons without HIV. The objective of this study was to evaluate changes in lipoproteins, apolipoproteins and other markers of inflammation with the use of pravastatin and fenofibrate.

designEvaluation of participants in ACTG A5087, a randomized trial of pravastatin 40 mg/day or fenofibrate 200 mg/day for the treatment of dyslipidemia. Participants that failed single-agent therapy at week 12 were given the combination.

methodsParticipants with available specimens were tested for apolipoproteins A1 and B, adiponectin, plasminogen-activator inhibitor type 1 (PAI-1), P-selectin, and high-sensitivity C-reactive protein (hs-CRP).

results74 participants (37 per randomized arm) received either pravastatin or fenofibrate for 12 weeks with 60 receiving combination treatment from weeks 12-48. There were no significant changes in hs-CRP, PAI-1, and P-selectin. From baseline to week 12, the median Apo B levels (-8 mg/dL, P=0.01 for fenofibrate and -27 mg/dL, P<0.01 for pravastatin) and ApoB/A1 ratios (-0.16, P<0.01 for both arms) significantly decreased. From baseline to week 48, median adiponectin (-1 ng/dL, P<0.01), Apo B (-22 mg/dL, P<0.01) and Apo B/A1 ratios (-0.2, P<0.01) all decreased in those who went on combination therapy, whereas Apo A1 (9.5 mg/dL, P=0.01) levels increased.

conclusionTreatment with pravastatin or fenofibrate improves the atherogenic lipid profile within the first 12 weeks and is sustained through 48 weeks with combination therapy. Adiponectin levels decrease with lipid-lowering therapy. However, markers of inflammation and platelet activation were not appreciably changed suggesting that the biologic properties of these agents differ in persons with HIV infection.

Indexed as

AdiponectinAdultAgedAnticholesteremic AgentsAnti-Retroviral AgentsApolipoproteins AApolipoproteins BBiomarkersC-Reactive ProteinDrug Administration ScheduleDyslipidemiasFemaleFenofibrateHIV InfectionsHumansMaleAdiponectinAnticholesteremic AgentsAnti-Retroviral AgentsApolipoproteins AApolipoproteins BBiomarkersC-Reactive ProteinFenofibratePlasminogen Activator Inhibitor 1PravastatinP-SelectinRNA, ViralAntiretroviral therapyApolipoproteinsDyslipidemiaFenofibrateHIVInflammationLipoproteinsPravastatin

Identifiers

PMID20824151
PMCPMC2932453
OpenAlexW2047549051

What OpenQuestion holds

Texttitle and abstract
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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.