Evidence map›Paper›PMID 19770624›Full record

Trial reportAIDS (London, England)2009

Short-term ezetimibe is well tolerated and effective in combination with statin therapy to treat elevated LDL cholesterol in HIV-infected patients.

Dominic Chow, Huichao Chen, Marshall J Glesby, Anthony Busti, Scott Souza, Janet Andersen, Sharon Kohrs, Julia Wu, Susan L Koletar

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.6field-weighted citation impact, top 11% 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.

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

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Primary Prevention for People Living With HIV: A Call to Action.Journal of the American College of Cardiology · 2026
    Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Novel functions of PXR in cardiometabolic disease.Biochimica et biophysica acta · 2016
    Review
  9. Review
  10. 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

9 authors at 5 institutions in 1 country.

Dominic ChowUniversity of Hawaii, John A. Burns School of Medicine, Hawaii AIDS Clinical Research Program, 3675 Kilauea Avenue, 5th Floor, Young Building, Honolulu, HI 96816, USA. dominicc@hawaii.edu
Huichao Chen
Marshall J Glesby
Anthony Busti
Scott Souza
Janet Andersen
Sharon Kohrs
Julia Wu
Susan L Koletar
University of Hawaiʻi at Mānoa · USCornell University · USTexas Tech University Health Sciences Center · USThe Ohio State University · USUniversity of Cincinnati · 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 Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
Alabama-Clinical Trials UnitU01AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, MICHAEL S. · 2007 to 2011
$16.6M
Case AIDS Clinical Trials UnitU01AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI LEDERMAN, MICHAEL MARCEL · 2007 to 2011
$14.7M
WOMEN'S HEALTH AGENDAU01AI025859 · NIAID · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI GOLDMAN, MITCHELL · 1987 to 2008
$14.5M
University of Pittsburgh Clinical Trials UnitU01AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MELLORS, JOHN W · 2007 to 2011
$13.9M
YOHIMBINE CHALLENGE IN PARKINSONIAN PATIENTS WITH PANIC DISORDERM01RR000044 · NCRR · UNIVERSITY OF ROCHESTER · PI GUZICK, DAVID S · 1985 to 2006
$13.8M
NCRR NIH HHS M01 RR000044NHLBI NIH HHS K23 HL088981NIAID NIH HHS AI68634NIAID NIH HHS AI68636NIAID NIH HHS K24 AI078884NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069434NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069494NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069511NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069532NIAID NIH HHS U01 AI069556NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069434NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069532
6 · The paper itself

Abstract

backgroundEzetimibe inhibits intestinal absorption of cholesterol.

methodsMulticentered double-blind, randomized, placebo-controlled, crossover study to determine the short-term safety, efficacy, and tolerability of ezetimibe in combination with ongoing statin therapy in HIV-infected adults with elevated low-density lipoprotein cholesterol (LDL-C). Participants on stable HAART with fasting LDL-C at least 130 mg/dl and stable statin were randomized to ezetimibe 10 mg daily or placebo for 12 weeks followed by 4 weeks of washout and then 12 weeks with alternative study assignment. Percentage and absolute change in LDL-C (primary endpoint), total cholesterol, triglyceride, high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, and high sensitivity C-reactive protein were compared. Changes in clinical symptoms and safety laboratory measurements were assessed.

resultsForty-four participants enrolled: 70% men, median age 49 years, 43% White/Non-Hispanic, median CD4 cell count 547 cells/microl, and 95% HIV RNA less than 50 copies/ml. Median (interquartile range) percentage change in LDL-C was -20.8% (-25.4, -10.7) with ezetimibe and -0.7% (-10.3,18.6) with placebo; the median within-participant effect of ezetimibe was -14.1% (-33.0, -5.0; P < 0.0001). Median difference in absolute LDL-C values between ezetimibe and placebo was -32 mg/dl (-58, -6, P < 0.0001). Significant differences in within-participant effect of ezetimibe were noted for total cholesterol -18.60% (-27.22, -11.67, P < 0.001), non-HDL-C -23.18% (-33.14, -14.36, P < 0.0001), and apolipoprotein B -8.73% (-18.75, 1.99, P = 0.02). No significant changes seen in HDL-C, triglyceride, or high sensitivity C-reactive protein. Ezetimibe was well tolerated. Adverse events were similar between phases.

conclusionThe present short-term study found adding ezetimibe to ongoing statin therapy was well tolerated and effective in reducing LDL-C, total cholesterol, non-HDL-C, and apolipoprotein B. Adding ezetimibe to statin therapy offers reasonable treatment option for HIV-infected patients with elevated LDL-C.

Indexed as

Anticholesteremic AgentsAntiretroviral Therapy, Highly ActiveAzetidinesCD4 Lymphocyte CountCholesterol, LDLCross-Over StudiesDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEzetimibeFemaleHIV InfectionsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleAnticholesteremic AgentsAzetidinesCholesterol, LDLEzetimibeHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID19770624
PMCPMC2782438
OpenAlexW2079256224

What OpenQuestion holds

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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 OpenQuestion graph.