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Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia

6. februar 2018 opdateret af: Antonio Hernandez Mijares, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study of Lipoprotein Subfractions, Inflammation, Oxidative Stress and Endothelial Function After Treatment With Simvastatin and Ezetimibe Administered Alone and in Combination in Hyperlipidemic Patients

Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with statins and ezetimibe generally constituting the medication of choice. By acting at different levels, the combination of these drugs allows the therapeutic objective to be achieved. However, it is not known how these drugs qualitatively affect the composition of lipoprotein subfractions, which differ in size and atherogenic potential. The investigators set out to evaluate this effect as well as their effects on inflammatory, oxidative stress and endothelial function parameters.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study consisted of a randomised parallel trial and took place during a period of 2 months. A total of 42 hyperlipidemic patients were randomly assigned to one of 2 groups: one received simvastatin (40 mg/day) and the other received ezetimibe (10 mg/day) for 4 weeks, after which both groups were administered combined therapy for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • LDL cholesterol concentration of between 160-190 mg/dl in patients with less than 2 cardiovascular risk factors
  • LDL concentration of between 130-160 mg/dl in patients that presented 2 or more cardiovascular risk factors.

Cardiovascular risk factors were defined as: age (≥ 45 years in men and ≥55 years in women), a smoking habit, hypertension (≥140/90 mmHg), diabetes mellitus, a high-density lipoprotein (HDL) cholesterol concentration of ≤ 40mg/dl, and a family history of cardiovascular disease.

Exclusion Criteria:

  • Triglyceride concentration > 400 mg/dl
  • Diabetes Mellitus
  • Kidney, liver, or thyroid disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Simvastatin
Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Medicin: Simvastatin
simvastatin (40 mg/day) for 4 weeks
Medicin: Simvastatin + Ezetimibe
combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period
Eksperimentel: Ezetimibe
Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Medicin: Simvastatin + Ezetimibe
combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period
Medicin: Ezetimibe
ezetimibe (10 mg/day) for 4 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Cholesterol Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Total cholesterol concentration was measured by enzymatic assay
Baseline, 4 weeks and 8 weeks
Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.
Baseline, 4 weeks and 8 weeks
High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method
Baseline, 4 weeks and 8 weeks
Triglycerides Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Triglyceride concentration were measured by enzymatic assay
Baseline, 4 weeks and 8 weeks
Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc
Baseline, 4 weeks and 8 weeks
Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.
Baseline, 4 weeks and 8 weeks
Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Levels of apolipoprotein B were determined by inmunonephelometry
Baseline, 4 weeks and 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay
Baseline, 4 weeks and 8 weeks
Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system
Baseline, 4 weeks and 8 weeks
Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system
Baseline, 4 weeks and 8 weeks
Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode
Baseline, 4 weeks and 8 weeks
Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques
Baseline, 4 weeks and 8 weeks
Membrane Potential Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques
Baseline, 4 weeks and 8 weeks
Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques
Baseline, 4 weeks and 8 weeks
Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period.
Baseline, 4 weeks and 8 weeks
Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds.
Baseline, 4 weeks and 8 weeks
Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm.
Baseline, 4 weeks and 8 weeks
Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system
Baseline, 4 weeks and 8 weeks
Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system
Baseline, 4 weeks and 8 weeks
Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration
Tidsramme: Baseline, 4 weeks and 8 weeks
E-selectin was evaluated in serum by Luminex® 200™ system
Baseline, 4 weeks and 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Efterforskere

  • Ledende efterforsker: Antonio Hernández, MD, Phd, FISABIO - University Hospital Dr Peset

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2009

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

25. november 2014

Først indsendt, der opfyldte QC-kriterier

26. november 2014

Først opslået (Skøn)

2. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SIM-EZE-2009-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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