Study design, rationale, and baseline characteristics: evaluation of fenofibric acid on carotid intima-media thickness in patients with type iib dyslipidemia with residual risk in addition to atorvastatin therapy (first) trial
Cardiovascular Drugs and Therapy, 06/01/2012
Davidson M et al. – This trial is the first to examine the effect of fenofibric acid on carotid intima–media thickness (CIMT) and the first CIMT trial to select patients with controlled low–density lipoprotein cholesterol (LDL–C) and elevated triglycerides (TG) and low high–density lipoprotein cholesterol (HDL–C) as inclusion criteria. Also, this trial will prospectively evaluate the effect of treatment on LDL particles and address shortcomings of previous CIMT trials.
- In this multicenter, double–blind study.
- 682 patients were randomized to once–daily delayed–release capsules of choline fenofibrate 135 mg (fenofibric acid [Trilipix; Abbott, North Chicago, IL]) or placebo plus atorvastatin treatment after a 2– to 10–week diet and atorvastatin run–in period.
- Key inclusion criteria included age ≥45 years; posterior–wall common CIMT ≥0.7 mm on at least one side at baseline; fasting results of TG ≥150 mg/dL, and HDL–C ≤45 mg/dL for men or HDL–C ≤55 mg/dL for women at screening while receiving atorvastatin; controlled LDL–C; and known coronary heart disease (CHD) or a CHD risk equivalent.
- The primary efficacy variable is the rate of change from baseline through week 104 in the mean posterior–wall intima–media thickness of the common carotid arteries (composite value of left and right sides).