Evidence map›Paper›PMID 39374532›Full record

Trial reportAnnals of internal medicine2024

Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial.

Kathleen V Fitch, Markella V Zanni, Jennifer Manne-Goehler, Marissa R Diggs, Arijeet K Gattu, Judith S Currier, Gerald S Bloomfield, Chiu-Bin Hsiao, Samir K Gupta, Judith A Aberg and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Annals of internal medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02344290. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

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

4 citing papers in PubMed.

  1. Primary Prevention for People Living With HIV: A Call to Action.Journal of the American College of Cardiology · 2026
    Article
  2. Review
  3. Article
  4. 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

16 authors.

Kathleen V FitchMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (K.V.F., M.V.Z., M.R.D., A.K.G., S.K.Gupta).
Markella V ZanniMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (K.V.F., M.V.Z., M.R.D., A.K.G., S.K.Gupta).ORCID 0000-0002-4711-3956
Jennifer Manne-GoehlerDivision of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (J.M.-G.).ORCID 0000-0001-9295-0035
Marissa R DiggsMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (K.V.F., M.V.Z., M.R.D., A.K.G., S.K.Gupta).
Arijeet K GattuMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (K.V.F., M.V.Z., M.R.D., A.K.G., S.K.Gupta).
Judith S CurrierDivision of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California (J.S.C.).ORCID 0000-0003-4279-4737
Gerald S BloomfieldDepartment of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina (G.S.B.).ORCID 0000-0002-7176-1611
Chiu-Bin HsiaoDivision of Infectious Diseases, Drexel University College of Medicine, Philadelphia, Pennsylvania (C.-B.H.).
Samir K GuptaMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (K.V.F., M.V.Z., M.R.D., A.K.G., S.K.Gupta).ORCID 0000-0001-6031-8705
Judith A AbergDivision of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York (J.A.A.).ORCID 0000-0001-8162-0284
Carlos D MalvestuttoDivision of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio (C.D.M.).ORCID 0000-0003-3156-2965
Carl J FichtenbaumDivision of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio (C.J.F.).ORCID 0000-0002-6778-7253
Michael T LuCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (M.T.L.).ORCID 0000-0003-4696-9610
Pamela S DouglasDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina (P.S.D.).ORCID 0000-0001-9876-4049
Heather J RibaudoCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Heath, Boston, Massachusetts (H.J.R.).ORCID 0000-0002-0394-3990
Steven K GrinspoonDivision of Infectious Diseases, Indiana University School of Medicine, Indianapolis, Indiana (S.K.Grinspoon).

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
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
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
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
REPRIEVE COVID-19 Administrative SupplementU01HL123336 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI DOUGLAS, PAMELA SUSAN, GRINSPOON, STEVEN K. · 2014 to 2021
$52.4M
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
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
1/2 REPRIEVE Extension for Trial CompletionUG3HL164285 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI DOUGLAS, PAMELA SUSAN, GRINSPOON, STEVEN K. · 2023 to 2025
$14.2M
REPRIEVE - DCCU01HL123339 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI LU, MICHAEL TSE-YIN, RIBAUDO, HEATHER JANE · 2014 to 2019
$6.0M
2/2 REPRIEVE Extension for Trial CompletionU24HL164284 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI LU, MICHAEL TSE-YIN, RIBAUDO, HEATHER JANE · 2023 to 2025
$2.9M
NCATS NIH HHS UL1 TR002384NHLBI NIH HHS U01 HL123336NHLBI NIH HHS U01 HL123339NHLBI NIH HHS U24 HL164284NHLBI NIH HHS UG3 HL164285NIAID NIH HHS K24 AI157882NIAID NIH HHS P30 AI050410NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106701NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

backgroundREPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) led to new guidelines for statin use among people with HIV (PWH) with low to moderate risk for atherosclerotic cardiovascular disease (ASCVD). Little is known about the natural history of diabetes mellitus (DM) or mechanisms contributing to statin effects on DM among this population.

objectiveTo determine the contribution of known DM risk factors to excess risk for DM with pitavastatin in REPRIEVE.

designPhase 3, primary ASCVD prevention trial over a median of 5.6 years of follow-up. (ClinicalTrials.gov: NCT02344290).

settingGlobal, multicenter trial.

participants7731 PWH aged 40 to 75 years with low to moderate ASCVD risk (by the pooled cohort equations from the American College of Cardiology and American Heart Association) without DM at study entry.

interventionRandom 1:1 assignment to pitavastatin, 4 mg daily, or placebo. MEASUREMENTS: New-onset DM was determined at each visit by clinical diagnosis requiring initiation of medication treatment for DM. The incidence of new-onset DM was assessed in relation to predefined demographic and metabolic risk factors, stratified by treatment group. Treatment effects of pitavastatin on progression to new DM in key subgroups were determined.

resultsParticipants with at least 3 DM risk factors (vs. no risk factors) had increased risk for DM in each treatment group (incidence rate, 3.24 per 100 person-years [PY] vs. 0.34 per 100 PY [pitavastatin] and 2.66 per 100 PY vs. 0.27 per 100 PY [placebo]). The incidence of DM was highest in South Asia. In adjusted analyses, high body mass index, prediabetes, and metabolic syndrome components were strongly associated with new-onset DM (all LIMITATION: Pitavastatin was the only statin assessed; DM was assessed clinically.

conclusionMetabolic risk factors, including prediabetes and obesity, contributed to new-onset DM in statin- and placebo-treated participants. A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry. Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute of the National Institutes of Health.

Indexed as

Cardiovascular DiseasesHIV InfectionsHydroxymethylglutaryl-CoA Reductase InhibitorsQuinolinesAdultAgedDiabetes MellitusFemaleHumansMaleMiddle AgedRisk FactorsHydroxymethylglutaryl-CoA Reductase InhibitorspitavastatinQuinolines

Identifiers

PMID39374532
PMCPMC11573625

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
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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.