Hypercholesterolemia
Conditions
Brief summary
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.
Interventions
simvastatin/ezetimibe 10/20 mg
DRUGatorvastatin
atorvastatin 10 mg
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of hypercholesterolemia * LDL-C \>/= 130 mg/dL but \</=250 mg/dL and triglyceride (TG) \</= 350 mg/dL * National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline
Exclusion criteria
* Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C Lowering Efficacy | 6 weeks | LDL-C = low density lipoprotein cholesterol, measured in mg/dl. |
Participant flow
Pre-assignment details
After a 4-week diet/wash-out period, patients still at or above drug treatment thresholds established by National Cholesterol Education Program Adult Treatment Panel III Guidelines were randomized. Randomization was stratified according to LDL-C levels obtained 1 week pre-randomization: ≥130 to \<160 mg/dL; ≥160 to \<190 mg/dL; ≥190 mg/dL.
Participants by arm
| Arm | Count |
|---|---|
| Vytorin Ezetimibe 10 mg/Simvastatin 20 mg | 108 |
| Atorvastatin Atorvastatin 10 mg | 95 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Atorvastatin | Total | Vytorin |
|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 8.7 | 58.5 years STANDARD_DEVIATION 9.8 | 58.4 years STANDARD_DEVIATION 10.7 |
| Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata <130 mg/dl | 3 Participants | 5 Participants | 2 Participants |
| Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata >=130 to <160 mg/dl | 32 Participants | 77 Participants | 45 Participants |
| Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata >=160 to <190 mg/dl | 43 Participants | 84 Participants | 41 Participants |
| Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata >=190 mg/dl | 17 Participants | 37 Participants | 20 Participants |
| Body Mass Index | 25 kg/m2 STANDARD_DEVIATION 2.8 | 25.2 kg/m2 STANDARD_DEVIATION 2.8 | 25.3 kg/m2 STANDARD_DEVIATION 2.9 |
| Sex: Female, Male Female | 56 Participants | 113 Participants | 57 Participants |
| Sex: Female, Male Male | 39 Participants | 90 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 108 | 0 / 95 |
| serious Total, serious adverse events | 0 / 108 | 0 / 95 |
Outcome results
Primary
LDL-C Lowering Efficacy
LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
Time frame: 6 weeks
Population: Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vytorin | LDL-C Lowering Efficacy | -51 Percent Change from Baseline | Standard Deviation 14.7 |
| Atorvastatin | LDL-C Lowering Efficacy | -41 Percent Change from Baseline | Standard Deviation 16 |
p-value: <0.00195% CI: [-14.3, -5.7]ANOVA