Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
Kowa, KRE, Hypercholesterolemia, combined dyslipidemia, dyslipidemia, pitavastatin, NK-104, simvastatin
Brief summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
Interventions
DRUGpitavastatin
DRUGsimvastatin
Sponsors
Kowa Research Europe
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females (18-75 years of age) * At least two cardiovascular disease risk factors * Must have been following a restrictive diet * Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Exclusion criteria
* Homozygous familial hypercholesterolemia * Conditions which may cause secondary dyslipidemia * Uncontrolled diabetes mellitus * Abnormal pancreatic, liver or renal function * Abnormal serum creatine kinase (CK) above the pre-specified level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in LDL-C | 12 weeks | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | 12 weeks | Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (\< 160 mg/dL) |
Countries
Denmark, Netherlands, Spain, Sweden
Participant flow
Recruitment details
Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.
Pre-assignment details
Patients who qualified entered a 6-8 week wash-out/dietary lead-in period followed by a 12- week treatment period. Patients were randomly assigned to one of the two treatment groups: pitavastatin 4 mg QD, or simvastatin 40 mg QD in a ratio of 2:1.
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 4 mg QD Pitavastatin 4 mg once daily | 233 |
| Simvastatin 40 mg QD Simvastatin 40 mg once daily | 119 |
| Total | 352 |
Baseline characteristics
| Characteristic | Pitavastatin 4 mg QD | Simvastatin 40 mg QD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 31 Participants | 80 Participants |
| Age, Categorical Between 18 and 65 years | 184 Participants | 88 Participants | 272 Participants |
| Age Continuous | 60.1 years STANDARD_DEVIATION 6.82 | 60.9 years STANDARD_DEVIATION 6.78 | 60.3 years STANDARD_DEVIATION 6.81 |
| Sex: Female, Male Female | 75 Participants | 37 Participants | 112 Participants |
| Sex: Female, Male Male | 158 Participants | 82 Participants | 240 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 51 / — | 13 / — |
| serious Total, serious adverse events | 4 / — | 5 / — |
Outcome results
Primary
Percent Change From Baseline in LDL-C
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time frame: 12 weeks
Population: Subjects who completed the treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg QD | Percent Change From Baseline in LDL-C | -43.96 mg/dL | Standard Deviation 12.77 |
| Simvastatin 40 mg QD | Percent Change From Baseline in LDL-C | -43.77 mg/dL | Standard Deviation 14.416 |
Secondary
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (\< 160 mg/dL)
Time frame: 12 weeks
Population: Full analysis set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pitavastatin 4 mg QD | Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | 203 participants |
| Simvastatin 40 mg QD | Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | 101 participants |