Evidence map›Paper›PMID 23082133›Full record

Trial reportPloS one2012

Angiotensin converting enzyme inhibitor and HMG-CoA reductase inhibitor as adjunct treatment for persons with HIV infection: a feasibility randomized trial.

Jason V Baker, Kathleen Huppler Hullsiek, Rachel Prosser, Daniel Duprez, Richard Grimm, Russell P Tracy, Frank Rhame, Keith Henry, James D Neaton

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00982189. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
3.4field-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.

NCT00982189 nacompleted

Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study

Ran2009Enrolled37Registered outcomes9Posted comparisons0ConditionsCardiovascular Disease Risk, HIV InfectionArmslisinopril, pravastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pravastatin for lowering lipids.The Cochrane database of systematic reviews · 2023 · on this map
    Pooled it
  2. Pooled it
  3. Trial
  4. Rosuvastatin preserves renal function and lowers cystatin C in HIV-infected subjects on antiretroviral therapy: the SATURN-HIV trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Observational
  11. Article
  12. Evidence-based review of statin use in patients with HIV on antiretroviral therapy.Journal of clinical & translational endocrinology · 2017
    Review
  13. Inflammation, immune activation, and cardiovascular disease in HIV.AIDS (London, England) · 2016 · on this map
    Review
  14. Review
  15. Review
  16. Review
  17. HIV and aging: emerging research issues.Current opinion in HIV and AIDS · 2014
    Review
  18. Preventing Heart Failure in Inflammatory and Immune Disorders.Current cardiovascular risk reports · 2014
    Article
  19. Review
  20. 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

9 authors at 4 institutions in 1 country.

Jason V BakerDepartment of Medicine, Hennepin County Medical Center (HCMC), Minneapolis, Minnesota, USA. baker459@umn.edu
Kathleen Huppler Hullsiek
Rachel Prosser
Daniel Duprez
Richard Grimm
Russell P Tracy
Frank Rhame
Keith Henry
James D Neaton
University of Minnesota · USHennepin County Medical Center · USAbbott Northwestern Hospital · USUniversity of Vermont · US

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
NCATS NIH HHS UL1 TR000114
6 · The paper itself

Abstract

backgroundTreatments that reduce inflammation and cardiovascular disease (CVD) risk among individuals with HIV infection receiving effective antiretroviral therapy (ART) are needed. DESIGN AND

methodsWe conducted a 2 × 2 factorial feasibility study of lisinopril (L) (10 mg daily) vs L-placebo in combination with pravastatin (P) (20 mg daily) vs P-placebo among participants receiving ART with undetectable HIV RNA levels, a Framingham 10 year risk score (FRS) ≥ 3%, and no indication for ACE-I or statin therapy. Tolerability and adherence were evaluated. Longitudinal mixed models assessed changes in blood pressure (BP), blood lipids, and inflammatory biomarkers from baseline through months 1 and 4.

resultsThirty-seven participants were randomized and 34 [lisinopril/pravastatin (n=9), lisinopril/P-placebo (n=8), L-placebo/pravastatin (n=9), L-placebo/P-placebo (n=8)] attended at least one follow-up visit. Participants were 97% male, 41% white, 67% were current smokers, and 65% were taking a protease inhibitor. Median age was 48 years, CD4 count 483 cells/mm(3), FRS 7.79%, total cholesterol 184 mg/dL, and LDL-C 95 mg/dL. There was no treatment difference for pravastatin vs P-placebo in total cholesterol, LDL-C, or any of the inflammatory biomarkers. Participants randomized to lisinopril vs. L-placebo had significant declines in diastolic BP (-3.3 mmHg, p=0.05), hsCRP (-0.61 µg/mL, p=0.02) and TNF-α (-0.17 pg/mL, p=0.04). Participants taking lisinopril vs L-placebo were more likely to report missed doses (88 vs 35%; p=0.001) and have adherence <90% by pill count (42 vs. 0%; p=0.02). Few participants from either group reported side effects (n=3 vs. n=1).

conclusionsThe modest BP changes and decreased adherence with lisinopril and absence of lipid differences with pravastatin suggest future studies of these drug classes should consider a run-in period to assess adherence and use a different statin. Our results also indicate that ACE-I therapy may have anti-inflammatory benefits for ART-treated persons with HIV infection and this should be further evaluated.

trial registrationClinicalTrials.gov NCT00982189.

Indexed as

AdultAngiotensin-Converting Enzyme InhibitorsBiomarkersBlood PressureCholesterolFeasibility StudiesFemaleFollow-Up StudiesHIV InfectionsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsInflammationLisinoprilMaleMedication AdherenceMiddle AgedAngiotensin-Converting Enzyme InhibitorsBiomarkersCholesterolHydroxymethylglutaryl-CoA Reductase InhibitorsLisinoprilPlacebosPravastatin

Identifiers

PMID23082133
PMCPMC3474775
OpenAlexW2094513337

What OpenQuestion holds

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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.