Hypercholesterolemia
Conditions
Keywords
Hypercholesterolaemia
Brief summary
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
Interventions
simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are naïve to lowering lipid agent * Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.
Exclusion criteria
* Impaired kidney function * Increased liver enzyme levels * Pregnant women * Hypersensitivity to ezetimibe and other statin agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment | After 6 weeks of treatment | Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment | After 12 weeks of the treatment | If patients didn't achieve LDL-C \<100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. |
Participant flow
Recruitment details
Patient were recruited between September 2006 and May 2008.
Pre-assignment details
Patients who were naïve to lipid-lowering agent or patients who were treated with lipid-lowering agent and had 4 week' wash-out period were enrolled in the study. The eligible patients will be allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Vytorin Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C \< 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day. | 118 |
| Atorvastatin Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day. | 111 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 24 Weeks Follow-up (3 Centers) | Adverse Event | 1 | 0 |
| 24 Weeks Follow-up (3 Centers) | Lost to Follow-up | 2 | 2 |
| 24 Weeks Follow-up (3 Centers) | Protocol Violation | 2 | 1 |
| 24 Weeks Follow-up (3 Centers) | Withdrawal by Subject | 1 | 3 |
| Base Study (12 Week Follow-up) | Adverse Event | 1 | 0 |
| Base Study (12 Week Follow-up) | Death | 0 | 1 |
| Base Study (12 Week Follow-up) | Protocol Violation | 7 | 3 |
| Base Study (12 Week Follow-up) | Withdrawal by Subject | 9 | 8 |
Baseline characteristics
| Characteristic | Atorvastatin | Total | Vytorin |
|---|---|---|---|
| Age, Continuous | 61.74 years STANDARD_DEVIATION 9.94 | 61.30 years STANDARD_DEVIATION 9.59 | 60.89 years STANDARD_DEVIATION 9.28 |
| Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata LDL-C 130-159mg/dl | 61 Participants | 125 Participants | 64 Participants |
| Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata LDL-C <130mg/dl | 1 Participants | 1 Participants | 0 Participants |
| Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata LDL-C 160-189mg/dl | 31 Participants | 69 Participants | 38 Participants |
| Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata LDL-C >=190mg/dl | 18 Participants | 34 Participants | 16 Participants |
| Baseline values for Apolipoprotein B (Apo B) | 110.63 mg/dL STANDARD_DEVIATION 31.63 | 111.97 mg/dL STANDARD_DEVIATION 31.25 | 113.23 mg/dL STANDARD_DEVIATION 30.97 |
| Baseline values for High-Density Lipoprotein Cholesterol (HDL-C) | 48.9 mg/dL STANDARD_DEVIATION 13.01 | 48.55 mg/dL STANDARD_DEVIATION 11.65 | 48.23 mg/dL STANDARD_DEVIATION 10.25 |
| Baseline values for LDL-C:HDL-C | 3.54 Ratio STANDARD_DEVIATION 1.04 | 3.54 Ratio STANDARD_DEVIATION 1.08 | 3.54 Ratio STANDARD_DEVIATION 1.13 |
| Baseline values for Low-Density Lipoprotein Cholesterol(LDL-C) | 162.56 mg/dL STANDARD_DEVIATION 26.75 | 163.36 mg/dL STANDARD_DEVIATION 30.37 | 164.11 mg/dL STANDARD_DEVIATION 33.52 |
| Baseline values for Non HDL-C | 190.72 mg/dL STANDARD_DEVIATION 31.11 | 191.14 mg/dL STANDARD_DEVIATION 34.88 | 191.54 mg/dL STANDARD_DEVIATION 38.25 |
| Baseline values for Total Cholesterol (TC) | 239.58 mg/dL STANDARD_DEVIATION 30.86 | 240.51 mg/dL STANDARD_DEVIATION 35.51 | 241.4 mg/dL STANDARD_DEVIATION 39.53 |
| Baseline values for Triglycerides (TG) | 144 mg/dL STANDARD_DEVIATION 57.34 | 143 mg/dL STANDARD_DEVIATION 73.69 | 142 mg/dL STANDARD_DEVIATION 86.27 |
| Body Mass Index (BMI) | 24.86 Kg/m2 STANDARD_DEVIATION 2.64 | 24.92 Kg/m2 STANDARD_DEVIATION 2.78 | 24.97 Kg/m2 STANDARD_DEVIATION 2.92 |
| Body Weight | 64.40 Kilograms (Kg) STANDARD_DEVIATION 10.51 | 64.51 Kilograms (Kg) STANDARD_DEVIATION 10.12 | 64.61 Kilograms (Kg) STANDARD_DEVIATION 9.78 |
| Diastolic Blood Pressure | 77.74 mm Hg STANDARD_DEVIATION 10.53 | 76.77 mm Hg STANDARD_DEVIATION 15.98 | 75.86 mm Hg STANDARD_DEVIATION 10.16 |
| Sex: Female, Male Female | 53 Participants | 110 Participants | 57 Participants |
| Sex: Female, Male Male | 58 Participants | 119 Participants | 61 Participants |
| Systolic Blood Pressure | 129.53 mm Hg STANDARD_DEVIATION 16.65 | 127.94 mm Hg STANDARD_DEVIATION 15.98 | 126.44 mm Hg STANDARD_DEVIATION 15.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 108 | 22 / 103 |
| serious Total, serious adverse events | 0 / 108 | 5 / 103 |
Outcome results
Primary
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
Time frame: After 6 weeks of treatment
Population: The analysis used 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 Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment | 89 Participants |
| Atorvastatin | Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment | 63 Participants |
95% CI: [1.77, 7.78]
Secondary
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
If patients didn't achieve LDL-C \<100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.
Time frame: After 12 weeks of the treatment
Population: All patient treated (APT) approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vytorin | Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment | 85 Participants |
| Atorvastatin | Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment | 63 Participants |
95% CI: [1.32, 5.06]