Trial reportAIDS (London, England)2025

No evidence of pitavastatin effect on muscle area or density among people with HIV.

Kristine M Erlandson, Triin Umbleja, Heather J Ribaudo, Michael T Lu, Jana Taron, Marissa R Diggs, Pamela S Douglas, Kathleen V Fitch, Carl J Fichtenbaum, Markella V Zanni and 12 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2025. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. Cited by 1 paper.

2numbers the graph read from it
1cell of the map it votes in
1citing 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.

← favours the treatmentfavours the comparator →
1.000 · no effect
Height-adjusted MApitavastatin vs placebono clear difference · ascvdfeeds one cell of the map
Δ 0.50>0.2
The estimated treatment group differences in baseline-adjusted month 24 outcomes were minimal [within 0.5 cm 2 /m for height-adjusted MA with 95% confidence interval (95% CI) bounds within <1 cm 2 /m, and within 1 Hounsfield units (HU) for MD with 95% CI bounds within <3 HU; all P  > 0.2].
MDpitavastatin vs placebono clear difference · ascvdfeeds one cell of the map
Δ 1.00>0.2
The estimated treatment group differences in baseline-adjusted month 24 outcomes were minimal [within 0.5 cm 2 /m for height-adjusted MA with 95% confidence interval (95% CI) bounds within <1 cm 2 /m, and within 1 Hounsfield units (HU) for MD with 95% CI bounds within <3 HU; all P  > 0.2].

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×body weight & composition

InconclusiveOpen on the map →What to test next →

2 readable studies in this cell: 1 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.25no deciding trial · 0 families support, 0 contradict · against placebo
Without it
0.25This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2025
Δ 0.50
4 · 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

22 authors.

Kristine M ErlandsonDivision of Infectious Diseases, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
Triin UmblejaCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
Heather J RibaudoCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
Michael T LuCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Jana TaronCardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Marissa R DiggsMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Pamela S DouglasDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Kathleen V FitchMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Carl J FichtenbaumDivision of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Markella V ZanniMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Judith A AbergDivision of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
Maria C Rodriguez-BarradasInfectious Diseases Section, Michael E. DeBakey VA Medical Center.
Katharine BreauxInfectious Diseases Section, Michael E. DeBakey VA Medical Center.
Rosalba Gomez MoronesInfectious Diseases Section, Michael E. DeBakey VA Medical Center.
Craig A SponsellerKowa Pharmaceuticals America, Inc., Montgomery, Alabama.
Judith S CurrierDivision of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, California.
Gerald S BloomfieldDepartment of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Sarah M ChuMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Alex B LuMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Carlos D MalvestuttoDivision of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio.
Steven K GrinspoonMetabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Todd T BrownDivision of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University, Baltimore, Maryland, USA.

Funding

AIDS Clinical Trials Group for Research on Therapeutics for HIV and Related InfectionsUM1AI068636 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$229.0M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2021 to 2025
$81.6M
AIDS Clinical Trial Group Laboratory CenterUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$54.5M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$22.2M
Pitt-Ohio State Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 to 2025
$13.1M
1/2 REPRIEVE Extension for Trial CompletionUG3HL164285 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · 2023 to 2025
$9.5M
PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · UNIVERSITY OF COLORADO DENVER · 1995 to 2025
$7.7M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · MASSACHUSETTS GENERAL HOSPITAL · 1994 to 2025
$6.0M
2/2 REPRIEVE Extension for Trial CompletionU24HL164284 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · 2023 to 2025
$1.7M
NHLBI NIH HHS U01 HL123336NHLBI NIH HHS U01 HL123339NHLBI NIH HHS U24 HL164284NHLBI NIH HHS UG3 HL164285NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106701NIA NIH HHS R01 AG054366NIDDK NIH HHS P30 DK040561NIDDK NIH HHS P30 DK048520
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundSkeletal muscle area and muscle density are key determinants of physical function and typically decline with increasing age. Statins have well known musculoskeletal effects but whether statins impact muscle area or muscle density is not well established, especially in the setting of randomized treatment.

methodsREPRIEVE is a double-blind randomized trial evaluating the effect of pitavastatin for primary prevention of major adverse cardiovascular events in people with HIV (PWH). Thoracic paraspinal, pectoralis, and infraspinatus muscle area and muscle density were assessed among Mechanistic Substudy participants with CT at baseline and month 24.

resultsOf 804 substudy participants, 510 remained on study treatment and had imaging at baseline and month 24. Median age was 51 years; 17% were natal female, 35% Black, and 27% Hispanic. There were no apparent changes in muscle measures from baseline to month 24 within the treatment groups. The estimated treatment group differences in baseline-adjusted month 24 outcomes were minimal [within 0.5 cm 2 /m for height-adjusted MA with 95% confidence interval (95% CI) bounds within <1 cm 2 /m, and within 1 Hounsfield units (HU) for MD with 95% CI bounds within <3 HU; all P  > 0.2]. Findings were generally consistent in subgroup analyses.

conclusionPitavastatin was associated with no apparent change in muscle measures over 24 months, and with no evidence of detrimental effect among PWH.

Indexed as

Cardiovascular DiseasesHIV InfectionsHydroxymethylglutaryl-CoA Reductase InhibitorsMuscle, SkeletalQuinolinesAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedTomography, X-Ray ComputedHydroxymethylglutaryl-CoA Reductase InhibitorspitavastatinQuinolinesHIVmuscle areamuscle densitymyosteatosissarcopeniastatin

Identifiers

PMID40704993
PMCPMC12313271

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.