Evidence map›Paper›PMID 24662777›Full record

Trial reportPloS one2014

Effects of lipid-lowering drugs on high-density lipoprotein subclasses in healthy men-a randomized trial.

Heiner K Berthold, Manfredi Rizzo, Nadine Spenrath, Giuseppe Montalto, Wilhelm Krone, Ioanna Gouni-Berthold

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

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00317993 (Effects of Ezetimibe and Simvastatin on LDL Receptor Protein Expression and on LDL Receptor and HMG-CoA Reductase mRNA Expression in Mononuclear Cells), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT00317993 phase4completednot on this map

Effects of Ezetimibe and Simvastatin on LDL Receptor Protein Expression and on LDL Receptor and HMG-CoA Reductase mRNA Expression in Mononuclear Cells: a Randomized Controlled Study in Healthy Men

TypeinterventionalSponsorUniversity of CologneRan2004 to 2004Enrolled60ConditionsHealthy MenArmsezetimibe, simvastatin, ezetimibe plus simvastatin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. 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

6 authors at 3 institutions in 2 countries.

Heiner K BertholdDepartment of Internal Medicine and Geriatrics, Bielefeld Evangelical Hospital (EvKB), Bielefeld, Germany.
Manfredi RizzoBioMedical Department of Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy; Euro-Mediterranean Institute of Science and Technology, Palermo, Italy.
Nadine SpenrathCenter for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.
Giuseppe MontaltoBioMedical Department of Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy.
Wilhelm KroneCenter for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.
Ioanna Gouni-BertholdCenter for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.
University of Cologne · DEUniversity of Palermo · ITEvangelisches Krankenhaus Bielefeld · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CONTEXT AND

objectiveInvestigating the effects of lipid-lowering drugs on HDL subclasses has shown ambiguous results. This study assessed the effects of ezetimibe, simvastatin, and their combination on HDL subclass distribution. DESIGN AND

participantsA single-center randomized parallel 3-group open-label study was performed in 72 healthy men free of cardiovascular disease with a baseline LDL-cholesterol of 111±30 mg/dl (2.9±0.8 mmol/l) and a baseline HDL-cholesterol of 64±15 mg/dl (1.7±0.4 mmol/l). They were treated with ezetimibe (10 mg/day, n = 24), simvastatin (40 mg/day, n = 24) or their combination (n = 24) for 14 days. Blood was drawn before and after the treatment period. HDL subclasses were determined using polyacrylamide gel-tube electrophoresis. Multivariate regression models were used to determine the influence of treatment and covariates on changes in HDL subclass composition.

resultsBaseline HDL subclasses consisted of 33±10% large, 48±6% intermediate and 19±8% small HDL. After adjusting for baseline HDL subclass distribution, body mass index, LDL-C and the ratio triglycerides/HDL-C, there was a significant increase in large HDL by about 3.9 percentage points (P<0.05) and a decrease in intermediate HDL by about 3.5 percentage points (P<0.01) in both simvastatin-containing treatment arms in comparison to ezetimibe. The parameters obtained after additional adjustment for the decrease in LDL-C indicated that about one third to one half of these effects could be explained by the extent of LDL-C-lowering.

conclusionsIn healthy men, treatment with simvastatin leads to favorable effects on HDL subclass composition, which was not be observed with ezetimibe. Part of these differential effects may be due to the stronger LDL-C-lowering effects of simvastatin.

trial registrationClinicalTrials.gov NCT00317993.

Indexed as

Healthy VolunteersAdipokinesAdultAzetidinesBiomarkersDrug Therapy, CombinationEzetimibeGlucoseHumansHypercholesterolemiaHypolipidemic AgentsLipoproteins, HDLMaleSimvastatinAdipokinesAzetidinesBiomarkersEzetimibeGlucoseHypolipidemic AgentsLipoproteins, HDLSimvastatin

Identifiers

PMID24662777
PMCPMC3963857
OpenAlexW2079838050

What OpenQuestion 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 OpenQuestion graph.