Hypercholesterolemia
Conditions
Keywords
Metabolic Disorder
Brief summary
Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.
Interventions
simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
atorvastatin 10 mg; tablet, once daily, 8 Weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement * No history of diabetes and 100 \<=LDL-C \<=250 mg/dl
Exclusion criteria
* Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months * Congestive heart failure defined by New York Heart Association (NYHA) class III or IV * Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * Uncontrolled hypertension * Unstable angina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | Baseline and 8 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Baseline and 8 weeks | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk). |
Other
| Measure | Time frame |
|---|---|
| Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | Baseline and Week 8 |
Participant flow
Recruitment details
Patients were recruited between June 2007 and May 2008.
Pre-assignment details
Patients who have Metabolic syndrome and Hypercholesterolemia had 4 weeks wash-out period were enrolled in this study. The eligible patients was allocated to one of Vytorin 10/20 mg or Atorvastatin 10 mg group.
Participants by arm
| Arm | Count |
|---|---|
| Vytorin simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks | 130 |
| Atorvastatin atorvastatin 10 mg; tablet, once daily, 8 Weeks | 126 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Vytorin | Atorvastatin | Total |
|---|---|---|---|
| Age, Continuous | 58.96 years STANDARD_DEVIATION 9.42 | 60.26 years STANDARD_DEVIATION 9.44 | 59.61 years STANDARD_DEVIATION 9.44 |
| Body Mass Index (BMI) | 26.75 kg/m^2 STANDARD_DEVIATION 3.59 | 26.45 kg/m^2 STANDARD_DEVIATION 3.34 | 26.61 kg/m^2 STANDARD_DEVIATION 3.46 |
| Diastolic Blood Pressure | 81.01 mm Hg STANDARD_DEVIATION 8.47 | 82.11 mm Hg STANDARD_DEVIATION 8.49 | 81.55 mm Hg STANDARD_DEVIATION 8.48 |
| LDL-C (low-Density-Lipoprotein-Cholesterol) | 159.95 mg/dL STANDARD_DEVIATION 30.33 | 159.95 mg/dL STANDARD_DEVIATION 27.34 | 159.95 mg/dL STANDARD_DEVIATION 28.84 |
| Sex: Female, Male Female | 36 Participants | 43 Participants | 79 Participants |
| Sex: Female, Male Male | 94 Participants | 83 Participants | 177 Participants |
| Systolic Blood Pressure | 130.81 mm Hg STANDARD_DEVIATION 13.91 | 129.85 mm Hg STANDARD_DEVIATION 14.51 | 130.34 mm Hg STANDARD_DEVIATION 14.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / — | 29 / — |
| serious Total, serious adverse events | 1 / — | 1 / — |
Outcome results
Primary
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
Time frame: Baseline and 8 Weeks
Population: All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vytorin | Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | -49.29 Percent of Baseline Value | Standard Deviation 15.22 |
| Atorvastatin | Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | -38.05 Percent of Baseline Value | Standard Deviation 12.28 |
p-value: <0.0001ANCOVA
Secondary
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).
Time frame: Baseline and 8 weeks
Population: All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vytorin | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | 105 Participants attaining LDL-C goal |
| Atorvastatin | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | 93 Participants attaining LDL-C goal |
p-value: <0.0001ANCOVA
Other Pre-specified
Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.
Time frame: Baseline and Week 8
Population: All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vytorin | Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | 83.52 mg/dL | Standard Deviation 33.84 |
| Atorvastatin | Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | 98.27 mg/dL | Standard Deviation 21.82 |
p-value: <0.0001ANCOVA