Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
hypercholesterolemia, kowa, dyslipidemia, pitavastatin, NK-104, Primary Hypercholesterolemia or Combined Dyslipidemia
Brief summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
Interventions
DRUGPitavastatin
Pitavastatin once daily
DRUGSimvastatin
Simvastatin once daily
Sponsors
Kowa Research Europe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females (18-75 years) * Must have been following a restrictive diet * Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Exclusion criteria
* Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia; * Conditions which may cause secondary dyslipidemia. * Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%) * Abnormal serum creatine kinase (CK) above the pre-specified level * Abnormal pancreatic, liver or renal function * Significant heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | Baseline to 12 weeks | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Cholesterol Education Program (NCEP) LDL-C Target Attainment | 12 week | Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12 |
Countries
Finland, Italy, Norway, Russia, United Kingdom
Participant flow
Recruitment details
Subjects were randomized to one of 4 treatment arms based on inclusion/exclusion criteria.
Pre-assignment details
After a 6-8 week run in period when no lipid lowering therapy was allowed, subjects were randomized to one of 4 treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 2 mg Pitavastatin 2 mg once daily | 311 |
| Simvastatin 20 mg Simvastatin 20 mg once daily | 107 |
| Pitavastatin 4 mg Pitavastatin 4 mg once daily | 320 |
| Simvastatin 40 mg Simvastatn 40 mg once daily | 110 |
| Total | 848 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 2 | 8 | 1 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 1 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 5 | 7 | 2 |
Baseline characteristics
| Characteristic | Pitavastatin 2 mg | Simvastatin 20 mg | Pitavastatin 4 mg | Simvastatin 40 mg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 97 Participants | 35 Participants | 89 Participants | 34 Participants | 255 Participants |
| Age, Categorical Between 18 and 65 years | 214 Participants | 72 Participants | 231 Participants | 76 Participants | 593 Participants |
| Age Continuous | 58.7 years STANDARD_DEVIATION 8.83 | 58.6 years STANDARD_DEVIATION 9.64 | 57.7 years STANDARD_DEVIATION 8.97 | 58.4 years STANDARD_DEVIATION 9.54 | 58.3 years STANDARD_DEVIATION 9.08 |
| Sex: Female, Male Female | 196 Participants | 63 Participants | 195 Participants | 48 Participants | 502 Participants |
| Sex: Female, Male Male | 115 Participants | 44 Participants | 125 Participants | 62 Participants | 346 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 56 / 311 | 28 / 107 | 44 / 320 | 10 / 110 |
| serious Total, serious adverse events | 3 / 311 | 2 / 107 | 4 / 320 | 2 / 110 |
Outcome results
Primary
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 2 mg | Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | -38.99 Percent change | Standard Deviation 14.573 |
| Simvastatin 20 mg | Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | -34.97 Percent change | Standard Deviation 15.528 |
| Pitavastatin 4 mg | Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | -43.97 Percent change | Standard Deviation 14.494 |
| Simvastatin 40 mg | Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | -42.84 Percent change | Standard Deviation 15.769 |
Secondary
National Cholesterol Education Program (NCEP) LDL-C Target Attainment
Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12
Time frame: 12 week
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pitavastatin 2 mg | National Cholesterol Education Program (NCEP) LDL-C Target Attainment | 215 Participants |
| Simvastatin 20 mg | National Cholesterol Education Program (NCEP) LDL-C Target Attainment | 69 Participants |
| Pitavastatin 4 mg | National Cholesterol Education Program (NCEP) LDL-C Target Attainment | 253 Participants |
| Simvastatin 40 mg | National Cholesterol Education Program (NCEP) LDL-C Target Attainment | 86 Participants |