N/A
N=42
Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT02304926 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Total Cholesterol Before and After Simvastatin/Ezetimibe Administration — 255; 253; 180; 215 mg/dl — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Simvastatin (Drug); Ezetimibe (Drug); Simvastatin + Ezetimibe (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cholesterol Before and After Simvastatin/Ezetimibe Administration |
255; 253; 180; 215; 173; 169 | <0.05 sig |
| PRIMARY Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration |
178; 172; 106; 138; 98; 94 | <0.05 sig |
| PRIMARY High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration |
47; 53; 50; 53; 51; 53 | <0.05 sig |
| PRIMARY Triglycerides Before and After Simvastatin/Ezetimibe Administration |
141; 120; 117; 105; 104; 81 | <0.05 sig |
| PRIMARY Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration |
208; 200; 130; 162; 122; 115 | <0.05 sig |
| PRIMARY Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration |
268.1; 270.4; 270.4; 271.5; 271.7; 272.0 | <0.05 sig |
| PRIMARY Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration |
139; 127; 92; 110; 84; 79 | <0.05 sig |
| SECONDARY Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration |
4.02; 4.43; 2.82; 3.98; 2.64; 3.31 | <0.05 sig |
| SECONDARY Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration |
2.44; 2.94; 2.83; 3.93; 4.43; 5.78 | >0.05 |
| SECONDARY Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration |
3.43; 3.01; 3.99; 5.09; 4.43; 4.35 | >0.05 |
| SECONDARY Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration |
1.09; 1.09; 1.54; 1.31; 1.76; 1.67 | <0.05 sig |
| SECONDARY Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration |
74.7; 72.8; 57.2; 63.5; 43.3; 48.9 | <0.05 sig |
| SECONDARY Membrane Potential Before and After Simvastatin/Ezetimibe Administration |
46.6; 48.4; 62.5; 56.7; 70.4; 67.5 | <0.05 sig |
| SECONDARY Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration |
2.68; 2.85; 5.67; 3.79; 7.92; 7.51 | <0.05 sig |
| SECONDARY Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration |
412; 421; 225; 392; 147; 196 | <0.05 sig |
| SECONDARY Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration |
25.1; 25.6; 15.0; 23.8; 10.9; 12.5 | <0.05 sig |
| SECONDARY Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration |
469; 524; 553; 533; 608; 629 | <0.05 sig |
| SECONDARY Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration |
1314; 1371; 1137; 1166; 1074; 1220 | >0.05 |
| SECONDARY Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration |
188; 160.6; 139.5; 114.7; 122.2; 108.1 | <0.05 sig |
| SECONDARY Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration |
45.1; 39.7; 38.9; 30.5; 29.2; 24.4 | <0.05 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02304926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.