Evidence map›Paper›PMID 38381407›Full record

ArticleJAMA cardiology2024

Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV: Mechanistic Substudy of the REPRIEVE Randomized Clinical Trial.

Michael T Lu, Heather Ribaudo, Borek Foldyna, Markella V Zanni, Thomas Mayrhofer, Julia Karady, Jana Taron, Kathleen V Fitch, Sara McCallum, Tricia H Burdo and 19 more

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in JAMA cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT02344290. Cited by 54 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 4 pooled it
47.7field-weighted citation impact, top 1% 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.

NCT02344290 phase3completed

Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE

Ran2015Enrolled7,769Registered outcomes37Posted comparisons40ConditionsCardiovascular Diseases, HIVArmsPitavastatin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 4 syntheses or guidelines pooled it, 69 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 13 institutions in 3 countries.

Michael T LuCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Heather RibaudoCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Borek FoldynaCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Markella V ZanniMetabolism Unit, Massachusetts General Hospital, Harvard Medical School, Boston.
Thomas MayrhoferCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Julia KaradyCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Jana TaronCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Kathleen V FitchMetabolism Unit, Massachusetts General Hospital, Harvard Medical School, Boston.
Sara McCallumMetabolism Unit, Massachusetts General Hospital, Harvard Medical School, Boston.
Tricia H BurdoDepartment of Microbiology, Immunology, and Inflammation, Center for NeuroVirology and Gene Editing, Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania.
Kayla ParadisCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Sandeep S HedgireCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Nandini M MeyersohnCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Christopher DeFilippiInova Heart and Vascular Institute, Falls Church, Virginia.
Carlos D MalvestuttoDivision of Infectious Diseases, Ohio State University Medical Center, Columbus.
Audra SturnioloCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Marissa DiggsMetabolism Unit, Massachusetts General Hospital, Harvard Medical School, Boston.
Sue SiminskiFrontier Science Foundation, Amherst, New York.
Gerald S BloomfieldDepartment of Medicine, Duke Global Health Institute, Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Beverly Alston-SmithDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Patrice Desvigne-NickensDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Edgar T OvertonDivision of Infectious Diseases, University of Alabama at Birmingham.
Judith S CurrierDivision of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles.
Judith A AbergDivision of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
Carl J FichtenbaumDivision of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Udo HoffmannCleerly, Denver, Colorado.
Pamela S DouglasDuke University Research Institute, Duke University School of Medicine, Durham, North Carolina.
Steven K GrinspoonMetabolism Unit, Massachusetts General Hospital, Harvard Medical School, Boston.
REPRIEVE Trial Writing Group
Harvard University · USDuke University · USNational Institutes of Health · USCancer Research And Biostatistics · USFrontier Science & Technology Research Foundation · USIcahn School of Medicine at Mount Sinai · USSemmelweis University · HUTemple University · USThe Ohio State University Wexner Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, Los Angeles · USUniversity of Cincinnati Medical Center · USAlaska Heart and Vascular Institute · US

Funding

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
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David W Haas, Spyros A Kalams · 2012 to 2026
$33.1M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Elizabeth Austen Lawson, Takara Leah Stanley · 1994 to 2026
$31.6M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
1/2 REPRIEVE Extension for Trial CompletionUG3HL164285 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI DOUGLAS, PAMELA SUSAN, GRINSPOON, STEVEN K. · 2023 to 2025
$14.2M
COLUMBIA-ADARC-CORNELL AIDS CLINICAL TRIALS UNITU01AI046386 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2000 to 2006
$10.4M
NCATS NIH HHS UL1 TR002384NHLBI NIH HHS U01 HL123339NHLBI NIH HHS U24 HL164284NHLBI NIH HHS UG3 HL164285NIAID NIH HHS K24 AI157882NIAID NIH HHS U01 AI046386NIAID NIH HHS U01 AI069470NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069494NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

Importance: Cardiovascular disease (CVD) is increased in people with HIV (PWH) and is characterized by premature noncalcified coronary plaque. In the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), pitavastatin reduced major adverse cardiovascular events (MACE) by 35% over a median of 5.1 years. Objective: To investigate the effects of pitavastatin on noncalcified coronary artery plaque by coronary computed tomography angiography (CTA) and on inflammatory biomarkers as potential mechanisms for MACE prevention. Design, Setting, and Participants: This double-blind, placebo-controlled randomized clinical trial enrolled participants from April 2015 to February 2018 at 31 US clinical research sites. PWH without known CVD who were taking antiretroviral therapy and had low to moderate 10-year CVD risk were included. Data were analyzed from April to November 2023. Intervention: Oral pitavastatin calcium, 4 mg per day. Main Outcomes and Measures: Coronary CTA and inflammatory biomarkers at baseline and 24 months. The primary outcomes were change in noncalcified coronary plaque volume and progression of noncalcified plaque. Results: Of 804 enrolled persons, 774 had at least 1 evaluable CTA. Plaque changes were assessed in 611 who completed both CT scans. Of 611 analyzed participants, 513 (84.0%) were male, the mean (SD) age was 51 (6) years, and the median (IQR) 10-year CVD risk was 4.5% (2.6-7.0). A total of 302 were included in the pitavastatin arm and 309 in the placebo arm. The mean noncalcified plaque volume decreased with pitavastatin compared with placebo (mean [SD] change, -1.7 [25.2] mm3 vs 2.6 [27.1] mm3; baseline adjusted difference, -4.3 mm3; 95% CI, -8.6 to -0.1; P = .04; 7% [95% CI, 1-12] greater reduction relative to placebo). A larger effect size was seen among the subgroup with plaque at baseline (-8.8 mm3 [95% CI, -17.9 to 0.4]). Progression of noncalcified plaque was 33% less likely with pitavastatin compared with placebo (relative risk, 0.67; 95% CI, 0.52-0.88; P = .003). Compared with placebo, the mean low-density lipoprotein cholesterol decreased with pitavastatin (mean change: pitavastatin, -28.5 mg/dL; 95% CI, -31.9 to -25.1; placebo, -0.8; 95% CI, -3.8 to 2.2). The pitavastatin arm had a reduction in both oxidized low-density lipoprotein (-29% [95% CI, -32 to -26] vs -13% [95% CI, -17 to -9]; P < .001) and lipoprotein-associated phospholipase A2 (-7% [95% CI, -11 to -4] vs 14% [95% CI, 10-18]; P < .001) compared with placebo at 24 months. Conclusions and Relevance: In PWH at low to moderate CVD risk, 24 months of pitavastatin reduced noncalcified plaque volume and progression as well as markers of lipid oxidation and arterial inflammation. These changes may contribute to the observed MACE reduction in REPRIEVE. Trial Registration: ClinicalTrials.gov Identifier: NCT02344290.

Indexed as

Cardiovascular DiseasesCoronary Artery DiseaseHIV InfectionsHydroxymethylglutaryl-CoA Reductase InhibitorsPlaque, AtheroscleroticQuinolinesBiomarkersDouble-Blind MethodFemaleHumansInflammationLipoproteins, LDLMaleMiddle AgedBiomarkersHydroxymethylglutaryl-CoA Reductase InhibitorsLipoproteins, LDLpitavastatinQuinolines

Identifiers

PMID38381407
PMCPMC10882511
OpenAlexW4392004733

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY
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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.