Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Statins, Ezetimibe
Brief summary
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.
Interventions
DRUGVytorin
Vytorin 10/80 split into 4
DRUGSimvastatin
Simvastatin 20 milligrams
Sponsors
Bronx VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with an LDL-cholesterol greater than 100 mg/dL * Patients willing and able to provide signed informed consent
Exclusion criteria
* Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol) * Patients intolerant of statins * Patients receiving ezetimibe * Patients intolerant of ezetimibe * Patients receiving a niacin preparation * Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months * Cancer undergoing active treatment * Creatinine clearance \< 50 ml/minute * Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level * Participation in any clinical study within the last 30 days * Drug addition or alcohol abuse within the past 6 months * Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months * Active use of macrolide antibiotics or verapamil * Consumption of grapefruit juice on a daily basis * Patients unwilling or unable to provide informed consent * Patients with poor compliance * Women of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL Cholesterol | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Total Cholesterol | 6 weeks |
Countries
United States
Participant flow
Recruitment details
Thirty-four patients were randomized from August 2007 through October 2008. Patients were recruited from our cardiology and lipid clinics.
Pre-assignment details
There was no washout phase during the study. No patients were excluded after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 1Vytorin 10/80 Divided Into 4 Vytorin 10/80 divided into 4 | 17 |
| Simvastatin Simvastatin 20 milligrams | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued medication | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Simvastatin | 1Vytorin 10/80 Divided Into 4 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 13 Participants | 24 Participants |
| Age Continuous | 62.7 years STANDARD_DEVIATION 7.8 | 55.3 years STANDARD_DEVIATION 12.6 | 59.1 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
LDL Cholesterol
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1Vytorin 10/80 Divided Into 4 | LDL Cholesterol | -44.7 % change in LDL cholesterol | Standard Deviation 19 |
| Simvastatin | LDL Cholesterol | -27.1 % change in LDL cholesterol | Standard Deviation 22.4 |
Secondary
Total Cholesterol
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1Vytorin 10/80 Divided Into 4 | Total Cholesterol | -34.2 % change in total cholesterol | Standard Deviation 13 |
| Simvastatin | Total Cholesterol | -19.9 % change in total cholesterol | Standard Deviation 14.6 |