Investigation on the effectiveness and safety of lipid-lowering treatments in patients with familial hypercholesterolemia (FAME: Familial Hypercholesterolemia Expert Forum Trial)
- Conditions
- familial hypercholesterolemia
- Registration Number
- JPRN-UMIN000003211
- Lead Sponsor
- Osaka University Graduate School of Medicine
- Brief Summary
762 heterozygous and 7 homozygous FH patients were enrolled. CAD was recorded in 23% of patients. Patients without CAD with LDL-C < 100mg/dL, 12.3% and those with CAD with < 70 mg/dL, 1.8%. Male gender, age > 40, FH score < 20, hypertension, and sibling CAD were significantly positively associated with CAD. Male gender, CAD at the baseline, and parental CAD were related to the development of atherosclerotic cardiovascular disease events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 769
Not provided
1) Patients whose serum triglyceride level is over 400 mg/dl at the time of registration should be excluded. 2) Patients who are suffering from severe liver dysfunction (acute phase and decompensated cirrhosis) 3) Patients with dyslipidemia who are suffering from the following diseases (1) hypothyroidism (2) pancreatitis 4) Patients with uncontrolled diabetes mellitus, whose HbA1c level is over 9%. 5) Patients who are pregnant, suckling or likely to be pregnant. 6) Patients who are judged by the doctor to be improper to be enrolled in this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method