Hypercholesterolemia With Type2DM
Conditions
Keywords
pitavastatin, PWV, ESPRIT, Pitavastatin and Atorvastatin, Adiponectin, fasting insulin, hs-CRP, baPWV
Brief summary
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Detailed description
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
Interventions
DRUGPitavastatin
Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
DRUGAtorvastatin
Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 25yrs\ 75yrs * Fasting TG \<400mg/dL, LDL-C ≥130mg/dL * 3months \> Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
Exclusion criteria
* Type1 DM, Gestational diabetes * Patient need to treat with Insulin * Patient with operational treatment for severe diabetic complication * Uncontrolled Hypothyroidism * Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4) * Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg) * Renal disorder (Serum creatinine ≥ 2.0mg/dL) * Hepatic disorder (AST or ALT ≥ 2.5 X UNL) * Creatinine Kinase \> 2.5 X UNL * Gravida or lactation phase * Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving LDL- C<100mg/dL | After 16wk drug administration | compare the proportion of patients achieving LDL- C\<100mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change of LDL-C | After 16wk drug administration | The change of LDL-C between at 16-week and baseline |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin Group Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks | 83 |
| Atorvastatin Group Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks | 78 |
| Total | 161 |
Baseline characteristics
| Characteristic | Atorvastatin Group | Total | Pitavastatin Group |
|---|---|---|---|
| Age, Continuous | 59.1 years | 59.3 years | 59.6 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment South Korea | 78 participants | 161 participants | 83 participants |
| Sex: Female, Male Female | 54 Participants | 109 Participants | 55 Participants |
| Sex: Female, Male Male | 24 Participants | 52 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 70 |
| other Total, other adverse events | 3 / 81 | 0 / 70 |
| serious Total, serious adverse events | 0 / 81 | 0 / 70 |
Outcome results
Primary
Proportion of Patients Achieving LDL- C<100mg/dL
compare the proportion of patients achieving LDL- C\<100mg/dL
Time frame: After 16wk drug administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pitavastatin Group | Proportion of Patients Achieving LDL- C<100mg/dL | 61 Participants |
| Atorvastatin Group | Proportion of Patients Achieving LDL- C<100mg/dL | 54 Participants |
Secondary
The Change of LDL-C
The change of LDL-C between at 16-week and baseline
Time frame: After 16wk drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin Group | The Change of LDL-C | -69.8 mg/dl | Standard Deviation 22.5 |
| Atorvastatin Group | The Change of LDL-C | -70.9 mg/dl | Standard Deviation 28.2 |