Evidence map›Paper›PMID 26872608›Full record

Trial reportLipids in health and disease2016

Effect of alirocumab on specific lipoprotein non-high-density lipoprotein cholesterol and subfractions as measured by the vertical auto profile method: analysis of 3 randomized trials versus placebo.

Peter P Toth, Sara C Hamon, Steven R Jones, Seth S Martin, Parag H Joshi, Krishnaji R Kulkarni, Poulabi Banerjee, Corinne Hanotin, Eli M Roth, James M McKenney

3 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lipids in health and disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–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.

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.

NCT01266876 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of REGN727 in Patients With Heterozygous Familial Hypercholesterolemia

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2011 to 2011Enrolled77ConditionsHypercholesterolemiaArmsAlirocumab, Placebo
NCT01288443 phase2completednot on this map

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Five Doses and Two Dose Regimens of SAR236553 Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥ 2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy

TypeinterventionalSponsorSanofiRan2011 to 2011Enrolled183ConditionsHypercholesterolemiaArmsAlirocumab, Placebo (for alirocumab), Atorvastatin
NCT01288469 phase2completednot on this map

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose/Dose Regimen, Multicenter Study Evaluating the Efficacy and Safety of SAR236553 When Co-administered With 80 mg of Atorvastatin Over 8 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥2.59 mmol/L) on Atorvastatin 10 mg

TypeinterventionalSponsorSanofiRan2011 to 2011Enrolled92ConditionsHypercholesterolemiaArmsAlirocumab, Placebo (for alirocumab), Atorvastatin, Placebo (for atorvastatin)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
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  12. Review
  13. The effect of chronic kidney disease on lipid metabolism.International urology and nephrology · 2019
    Review
  14. Article
  15. Threshold Effects of Circulating Angiopoietin-Like 3 Levels on Plasma Lipoproteins.The Journal of clinical endocrinology and metabolism · 2017
    Article
  16. Review
  17. PCSK9 targets important for lipid metabolism.Clinical research in cardiology supplements · 2017
    Review
  18. 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.

Peter P TothCGH Medical Center, 101 East Miller Rd, Sterling, Illinois, 61081, USA. peter.toth@cghmc.com.
Sara C HamonRegeneron, Tarrytown, NY, USA.
Steven R JonesJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Seth S MartinJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Parag H JoshiJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Krishnaji R KulkarniAtherotech, Birmingham, AL, USA.
Poulabi BanerjeeRegeneron, Tarrytown, NY, USA.
Corinne HanotinSanofi, Paris, France.
Eli M RothThe Sterling Research Group, Cincinnati, OH, USA.
James M McKenneyVirginia Commonwealth University, Richmond, VA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effect of alirocumab on potentially atherogenic lipoprotein subfractions was assessed in a post hoc analysis using the vertical auto profile (VAP) method.

methodsPatients from three Phase II studies with low-density lipoprotein cholesterol (LDL-C) ≥ 2.59 mmol/L (100 mg/dL) at baseline on stable statin therapy were randomised to receive subcutaneous alirocumab 50-150 mg every 2 weeks (Q2W) or 150-300 mg every 4 weeks (according to study) or placebo for 8-12 weeks. Samples from patients treated with alirocumab 150 mg Q2W (n = 74; dose common to all three trials) or placebo (n = 71) were analysed by VAP. Percent change in lipoprotein subfractions with alirocumab vs. placebo was analysed at Weeks 6, 8 or 12 using analysis of covariance.

resultsAlirocumab significantly reduced LDL-C and the cholesterol content of subfractions LDL1, LDL2 and LDL3+4. Significant reductions were also observed in triglycerides, apolipoproteins CII and CIII and the cholesterol content of very low-density, intermediate-density, and remnant lipoproteins.

conclusionAlirocumab achieved reductions across a spectrum of atherogenic lipoproteins in patients receiving background statin therapy.

trial registrationClinicaltrials.gov identifiers: NCT01288443, NCT01288469, NCT01266876.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLDouble-Blind MethodFemaleHumansHypercholesterolemiaLipid MetabolismLipoproteinsLipoproteins, HDLLipoproteins, VLDLMaleMiddle AgedTriglyceridesalirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLLipoproteinsLipoproteins, HDLLipoproteins, VLDLTriglycerides

Identifiers

PMID26872608
PMCPMC4752766

What Socratic holds

Textmetadata
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 Socratic graph.