Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

NCT00932620 | Completed Phase 4 Results

• 1 other identifier: 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not been assessed. The aim of the present study is to compare the effects of simvastatin 40 mg versus simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3 months after treatment initiation.

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia; statins; simvastatin; ezetimibe; LDL particles

Outcome Measures

Primary Outcomes (1)

• Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels

  Baseline and 3 months

Secondary Outcomes (1)

• Changes in Low-density Lipoprotein Cholesterol (LDL-C)

  3 months

Study Arms (2)

Simvastatin 40 mg

ACTIVE COMPARATOR

All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg (n=50) or simvastatin/ezetimibe 10/10 mg (n=50) daily

Drug: SIMVASTATIN 40 mg

Simvastatin 10 mg plus ezetimibe 10 mg

ACTIVE COMPARATOR

All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg (n=50) or simvastatin/ezetimibe 10/10 mg (n=50) daily

Drug: SIMVASTATIN/EZETIMIBE 10/10 mg

Interventions

SIMVASTATIN 40 mg DRUG

SIMVASTATIN 40 mg/day for 3 months

Simvastatin 40 mg

SIMVASTATIN/EZETIMIBE 10/10 mg DRUG

SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months

Simvastatin 10 mg plus ezetimibe 10 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-C levels above those recommended by the National Cholesterol Education
• Program Adult Treatment Panel III (NCEP-ATP III) based on each patient risk factors following a 3-month period of lifestyle changes.

You may not qualify if:

• Triglycerides \>500 mg/dL, renal disease (serum creatinine levels \>1.6 mg/dL), hypothyroidism \[thyroid stimulating hormone (TSH) \>5 IU/mL\] and liver disease (ALT and/or AST levels \>3-fold upper limit of normal in 2 consecutive measurements).
• Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
• Patients currently taking lipid lowering drugs or having stopped them less than 4 weeks before study entry will be excluded

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Ioannina, 45 110, Greece

Location

Related Publications (1)

• Florentin M, Liberopoulos EN, Moutzouri E, Rizos CV, Tselepis AD, Elisaf MS. The effect of simvastatin alone versus simvastatin plus ezetimibe on the concentration of small dense low-density lipoprotein cholesterol in subjects with primary hypercholesterolemia. Curr Med Res Opin. 2011 Mar;27(3):685-92. doi: 10.1185/03007995.2010.546394. Epub 2011 Jan 27.

  PMID: 21271793 RESULT

Related Links

• 2nd Department of Internal Medicine, University Hospital of Ioannina

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Simvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations of our study include its open-label design and the lack of clinical endpoints. However, all laboratory determinations were performed blindly with regard to treatment allocation.

Results Point of Contact

• Title: Prof Moses Elisaf
• Organization: University of Ioannina

egepi@cc.uoi.gr

+302651007509

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 19, 2011
• Results First Posted: August 12, 2011

Record last verified: 2011-06

Locations

GR (1)