Evidence map›Paper›PMID 25148829›Full record

Trial reportJournal of the International AIDS Society2014

Dyslipidemia in HIV-positive patients: a randomized, controlled, prospective study on ezetimibe+fenofibrate versus pravastatin monotherapy.

Anna M Grandi, Eleonora Nicolini, Laura Rizzi, Sara Caputo, Filippo Annoni, Anna M Cremona, Chiara Marchesi, Luigina Guasti, Andrea M Maresca, Paolo Grossi

Open access · goldFull text readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the International AIDS Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 24% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Evidence-based review of statin use in patients with HIV on antiretroviral therapy.Journal of clinical & translational endocrinology · 2017
    Review
  7. 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

10 authors at 1 institution in 1 country.

Anna M GrandiDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Eleonora NicoliniDepartment of Internal Medicine, Ospedale di Circolo, Varese, Italy; elonikolini@libero.it.
Laura RizziDepartment of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
Sara CaputoDepartment of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
Filippo AnnoniDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Anna M CremonaDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Chiara MarchesiDepartment of Internal Medicine, Ospedale di Circolo, Varese, Italy.
Luigina GuastiDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Andrea M MarescaDepartment of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Paolo GrossiDepartment of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
University of Insubria · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe designed a randomized, controlled prospective study aimed at comparing efficacy and tolerability of ezetimibe+fenofibrate treatment versus pravastatin monotherapy in dyslipidemic HIV-positive (HIV+) patients treated with protease inhibitors (PIs).

methodsWe consecutively enrolled 42 HIV+ dyslipidemic patients on stable PIs therapy (LDL cholesterol >130 mg/dl or triglycerides 200-500 mg/dl with non-HDL cholesterol >160 mg/dl). After basal evaluation, patients were randomized to a six-month treatment with ezetimibe 10 mg/day+fenofibrate 200 mg/day or with pravastatin 40 mg/day. Both at the basal evaluation and after the six-month treatment, the patients underwent blood tests for lipid parameters, and muscle and liver enzymes.

resultsAt baseline, the two groups (21 patients each) were similar with regards to gender, age, BMI, blood pressure and virologic and metabolic parameters. After the six-month therapy, total cholesterol, LDL cholesterol and non-HDL cholesterol decreased significantly (p<0.01) in both groups. high-density lipoprotein (HDL) cholesterol increased (44 ± 10 to 53 ± 12 mg/dl, p<0.005) and triglycerides decreased (from 265 ± 118 mg/dl to 149 ± 37 mg/dl, p<0.001) in the ezetimibe+fenofibrate group, whereas both parameters remained unchanged in the pravastatin group. Mean values of creatine kinase (CK), alanine aminotransferase and aspartate aminotransferase were unchanged in both groups; only one patient in the pravastatin group stopped the treatment after two months, due to increased CK.

conclusionsIn dyslipidemic HIV+ patients on PI therapy, the association of ezetimibe+fenofibrate is more effective than pravastatin monotherapy in improving lipid profile and is also well tolerated.

Indexed as

AdultAnticholesteremic AgentsAzetidinesDrug-Related Side Effects and Adverse ReactionsDyslipidemiasEzetimibeFemaleFenofibrateHIV InfectionsHIV Protease InhibitorsHumansMaleMiddle AgedPravastatinProspective StudiesTreatment OutcomeAnticholesteremic AgentsAzetidinesEzetimibeFenofibrateHIV Protease InhibitorsPravastatindyslipidemiaezetimibefenofibrateHIV infectionpravastatinprotease inhibitors

Identifiers

PMID25148829
PMCPMC4141938
OpenAlexW2006837126

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Registered trials

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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.