The overall objective of the CAP study was to determine genetic influences on efficacy of simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers of cardiovascular disease risk.
Despite widespread use of statin therapy for reducing risk of cardiovascular disease risk, there is considerable inter-individual variation in statin efficacy, and it would be desirable to identify markers that would be predictive of the magnitude of beneficial response. The effect of statin most strongly associated with improved clinical outcomes is reduction in LDL cholesterol. The CAP study was a six week non-randomized, open label study of simvastatin 40 mg/day in a group of 335 African-American and 609 Caucasian volunteer subjects. Measurements of plasma lipids and lipoproteins, as well as other markers of cardiovascular disease risk, were obtained at the screening and entry visits, and after four and six weeks of simvastatin treatment. Both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms. Significant findings are being replicated in other study cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
40mg/day
San Francisco General Hospital
San Francisco, California, United States
Total Cholesterol
Time frame: -2, 0, 4, 6 weeks
LDL Cholesterol
Time frame: -2, 0, 4, 6 weeks
HDL Cholesterol
Time frame: -2, 0, 4, 6 weeks
Triglycerides
Time frame: -2, 0, 4, 6 weeks
C-reactive protein
Time frame: -2, 0, 4, 6 weeks
Total Cholesterol/HDL Cholesterol
Time frame: -2, 0, 4, 6 weeks
Apolipoprotein B
Time frame: -2, 0, 4, 6 weeks
Apolipoprotein AI
Time frame: -2, 0, 4, 6 weeks
Apolipoprotein CIII
Time frame: -2, 0, 4, 6 weeks
LDL Peak Particle size
Time frame: -2, 0, 4, 6 weeks
LDL Subfractions
Time frame: -2, 0, 4, 6 weeks
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