Evidence map›Paper›PMID 17302378›Full record

Trial reportAntiviral therapy2006

Safety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: AIDS Clinical Trials Group Study A5148.

Michael P Dubé, Julia W Wu, Judith A Aberg, Mark A Deeg, Beverly L Alston-Smith, Mark E McGovern, Daniel Lee, Sharon L Shriver, Ana I Martinez, Martha Greenwald and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Antiviral therapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01683656 (ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 8% 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.

NCT01683656 phase4terminatedstarted 2012, after this paper: background citation

ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART

Ran2012Enrolled4Registered outcomes5Posted comparisons0ConditionsAtherosclerosis, HIVArmsNiacin/laropiprant, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. The effects of extended release niacin on lipoprotein sub-particle concentrations in HIV-infected patients.Hawai'i journal of medicine & public health : a journal of Asia Pacific Medicine & Public Health · 2013
    Trial
  4. Trial
  5. Trial
  6. Review
  7. The Plasma NADRejuvenation research · 2019
    Article
  8. Review
  9. Treatment of dyslipidemia in HIV.Current atherosclerosis reports · 2015
    Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. HIV and HAART-Associated Dyslipidemia.The open cardiovascular medicine journal · 2011
    Article
  17. Article
  18. Review
  19. Article
  20. Lipid management in patients who have HIV and are receiving HIV therapy.Endocrinology and metabolism clinics of North America · 2009
    Review
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

12 authors at 15 institutions in 1 country.

Michael P DubéDepartment of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. mpdube@iupui.edu
Julia W Wu
Judith A Aberg
Mark A Deeg
Beverly L Alston-Smith
Mark E McGovern
Daniel Lee
Sharon L Shriver
Ana I Martinez
Martha Greenwald
James H Stein
AIDS Clinical Trials Group A5148 Study Team
University of California, San Diego · USCase Western Reserve University · USIndiana University – Purdue University Indianapolis · USOffice of AIDS Research · USStanford University · USUniversity of Cincinnati · USUniversity of Miami · USWashington University in St. Louis · USHarvard University · USIndiana University School of MedicineMetroHealth · USMetroHealth Medical Center · USNew York University · USSocial and Scientific Systems (United States) · USUniversity of Wisconsin–Madison · US

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
XOLAIR IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH FOOD ALLERGYM01RR000070 · NCRR · STANFORD UNIVERSITY · PI RASGON, NATALIE L · 1985 to 2008
$32.4M
ZOSUQUIDAR TRIHYDROCHLORIDE DURING CONVENTIONAL INDUCTION AND POST-REMISSIONM01RR000750 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI RODRIGUEZ, HENRY · 1985 to 2008
$25.5M
WOMEN'S HEALTH AGENDAU01AI025859 · NIAID · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI GOLDMAN, MITCHELL · 1987 to 2008
$14.5M
WOMEN'S HEALTH AGENDAU01AI027670 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 1988 to 2006
$13.7M
WOMEN'S HEALTH AGENDAU01AI027661 · NIAID · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BALFOUR, HENRY H. · 1988 to 2008
$13.4M
WOMEN'S HEALTH AGENDAU01AI027665 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 1988 to 2006
$11.8M
WOMEN'S HEALTH AGENDAU01AI027663 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 1988 to 2006
$11.4M
WOMEN'S HEALTH AGENDAU01AI027675 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FISCHL, MARGARET A · 1988 to 2006
$10.5M
NCRR NIH HHS RR-00070NCRR NIH HHS RR-00750NIAID NIH HHS AI-25859NIAID NIH HHS AI25859NIAID NIH HHS AI27661NIAID NIH HHS AI-27663NIAID NIH HHS AI27670NIAID NIH HHS AI27675NIAID NIH HHS AI-38855NIAID NIH HHS AI-38858NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027663NIAID NIH HHS U01 AI027665NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858
6 · The paper itself

Abstract

backgroundDyslipidaemia is very common in patients with HIV infection, but current therapies are often suboptimal. Since niacin may cause insulin resistance and hepatotoxicity, it has generally been avoided in this setting.

methodsNon-diabetic male subjects (n=33) who had well-controlled HIV infection on antiretroviral therapy, fasting triglycerides > or =2.26 mmol/l and non-high density lipoprotein cholesterol (non-HDL-C) > or =4.66 mmol/l received escalating doses of extended-release niacin (ERN) up to 2,000 mg nightly for up to 44 weeks.

resultsFourteen subjects (42%) had pre-diabetes at entry. Twenty-three subjects (70%) received the maximum dose, eight (24%) received 1,500 mg. Niacin was well-tolerated. Only four subjects (12%) discontinued study treatment. There were small increases in fasting glycaemia and insulin resistance estimated by the homeostasis model assessment, but insulin resistance measures from the 2-h oral glucose tolerance test only transiently worsened. No subject developed persistent fasting hyperglycaemia; one had persistently elevated 2-h glucose >11.1 mmol/l. There were no significant changes in serum transaminases or uric acid. At week 48, the median change in fasting lipid levels in mmol/l (interquartile range) were: total cholesterol -0.21 (-1.35, -0.05), HDL-C +0.013 (-0.03,+0.28), non-HDL-C -0.49 (-1.37,+0.08) and triglycerides -1.73 (-3.68, -0.72). Favourable changes in large HDL and large very low density lipoprotein particle concentration were observed by nuclear magnetic resonance spectroscopy.

conclusionsERN in doses up to 2,000 mg daily was safe, well-tolerated and efficacious in HIV-infected subjects with atherogenic dyslipidaemia. Increases in glycaemia and insulin resistance tended to be transient.

Indexed as

AdultBlood GlucoseDelayed-Action PreparationsDyslipidemiasHIV InfectionsHumansHypolipidemic AgentsMaleMiddle AgedNiacinTriglyceridesBlood GlucoseDelayed-Action PreparationsHypolipidemic AgentsNiacinTriglycerides

Identifiers

PMID17302378
PMCPMC2288649
OpenAlexW2303640659

What OpenQuestion holds

Texttitle and abstract
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.