High LDL-cholesterol level
Conditions
Interventions
Ezetimibe Group
Pravastatin Group
Sponsors
Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine
Rinku General Medical Center(Osaka) Osaka Central Hospital (Osaka) Toyonaka Municipal Hospital(Osaka) Suita Municipal Hospital(Osaka)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Inclusion Criteria Outpatient whose LDL-C level was <180 mg/dl and who has not achieved lipid management goals based on risk assessment by Japan Atherosclerosis Society(JAS) Guidelines for Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases, 2007 Edition. 2) Eligibility Criteria (1)Patient who can be administrated either Ezetimibe or Pravastatin for the newly started lipid-lowering therapy (2)Patient who gave informed consent for the participation of this study
Exclusion criteria
Exclusion criteria: (1) Patient whose TG level was >150mg/dl at the entry period (2) Patient who suffered from moderate or severe hepatic dysfunction (3) Patients with acute coronary syndrome including unstable angina and acute myocardial infarction, old myocardial infarction and heart failure (Patients who are treated for the secondary prevention for heart disease (4) Patient with newly onset cerebrovascular disease (within 12 weeks after the onset) (5) Patient with uncontrolled diabetes mellitus (HbA1c>8.5%) (6) Patient with past history of drug allergy including shock, anaphylactic reaction or angioedema (7) Patient who took immunosuppressive drugs (8) Patient with familial hypercholesterolemia (9) Patient with hyperlipidemia caused by the following diseases; hypothyroidism, obstructive cholangitis, pancreatitis, Cushing disease, erythematosus, malignant lymphoma, Myeloma, Uncontrolled diabetes Mellitus (10) Alcoholics (11) Patient with hyperlipidemia caused by the steroid hormone or other related drugs (12) Patient who was pregnant or suckling, has the possibility of pregnancy or the wish of pregnancy by herself or her partner. (13) Patient who has the hypersensitivity of these drugs including their additive agent (14) Patient whom the doctor judged inappropriate (1) Patient who took specific health food containing plant sterols
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changing ratio of Cholesterol Absorption Markers | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) LDL-C, HDL-C and TG levels 2) Various lipid parameters including lipoprotein subclass and oxidized stress markers 3) Oxidized cholesterol level 4) Relationship between cholesterol absorption / synthesis markers and various lipid parameters including lipoprotein subclass and oxidized stress markers before the intervention of drugs 5) Relationship between changing value / ratio of LDL-C and cholesterol absorption / synthesis markers after the intervention of drugs 6) Relationship between changing value / ratio of oxidized cholesterol and cholesterol absorption / synthesis markers after the intervention of drugs 7) Diabetic parameters 8) Inflammatory parameters 9) Safety of drug usage | — |
Countries
Japan
Contacts
Public ContactDaisaku Masuda
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed