Hypercholesterolemia, Hypertension, Type 2 Diabetes
Conditions
Keywords
Hypercholesterolemia with concomitant type 2 diabetes and hypertension
Brief summary
The study is being conducted to compare the effect of standard treatment (target LDL-C level: \<120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: \<70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.
Interventions
DRUGPravastatin
5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)
DRUGRosuvastatin
5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)
Sponsors
Positive Trial Group
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting the following inclusion criteria will be included in the study: 1. Patients giving voluntary written consent to participate in the study 2. Male or female patients 50 years of age or older (at informed consent) 3. Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL) 4. Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy) 5. Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy) 6. Patients with two or more of the following risk factors * Male * 65 years of age or older * Smoker * L/H ratio: ≥3.0 •HbA1c level: ≥8.0% * Left ventricular hypertrophy * First- or second-degree family history of MACE * Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (\<60 mL/min/1.73 m2)
Exclusion criteria
Patients meeting the following criteria will be excluded from the study: 1. Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent 2. Patients judged to have familial hypercholesterolemia 3. Patients with a serum triglyceride level of ≥400 mg/dL 4. Patients with a history of myocardial infarction 5. Patients with a history of coronary revascularization (PCI or CABG) 6. Patients with a history of treatment of unstable angina 7. Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction) 8. Heart failure patients 9. Patients with a history of hypersensitivity to statins 10. Patients with a history of drug-induced myopathy 11. Patients with poorly controlled arrhythmia 12. Patients with severe liver or kidney disease 13. Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan 14. Patients who are or may be pregnant 15. Patients judged by the investigators to be ineligible for participation in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event | At baseline |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of MACE(combination of each category) | At baseline |
| Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) | At baseline |
| Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as L/H ratio) | At baseline |
| Prevention of individual MACE | At baseline |
| Frequency and distribution of type of hospitalizations during the study period | At baseline |
| Frequency of other events (malignancy, dementia, need of nursing care) | At baseline |
| Frequency and type of adverse events | At baseline |
| Frequency and distribution of type of deaths during the study period | At baseline |
Countries
Japan
Outcome results
None listed