Colesevelam/fenofibrate combination boosts efficacy in treatment of hyperlipidemia. Fenofibrate significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with mixed hyperlipidemia when
used in combination with the specifically engineered bile acid sequestrant (SE-BAS) colesevelam, according to a study published
in Current Medical Research and Opinion.
Compared with fenofibrate monotherapy, the fenofibrate/colesevelam mix also significantly reduced mean non-high-density lipoprotein
cholesterol (HDL-C), total cholesterol (TC), and apolipoprotein B (apo B) levels without significantly affecting the triglyceride
(TG)-lowering or HDL-C-raising effects of fenofibrate.
"These results have important implications for the management of patients with mixed hyperlipidemia," the authors stated.
They noted the recommendation of the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) that
a second treatment goal, as defined by non-HDL-C levels, be utilized for patients who had achieved their LDL-C treatment goal
but still displayed TG levels of greater than 200 mg/dL.
The randomized, double-blind, placebo-controlled, parallel-group study, the first to describe the effects of colesevelam in
patients with mixed hyperlipidemia, involved 129 patients, 119 of whom completed the trial. Following a 4- to 8-week wash-out
period, the subjects received fenofibrate 160 mg/d for 8 weeks before being randomized to receive colesevelam 3.75 g/d or
placebo in addition to fenofibrate 160 mg/d for 6 weeks. After 6 weeks of treatment, fenofibrate plus colesevelam produced a mean change of –10.4% in LDL-C, the primary efficacy end
point. Fenofibrate monotherapy resulted in a change of +2.3% (P<.0001). Fenofibrate plus colesevelam was significantly more effective than fenofibrate alone at reducing levels of secondary
end points non-HDL-C (9.6% difference), TC (7.4%), and apo B (8%) (P≤.0002).
No significant changes were recorded in the levels of other secondary end points, including HDL-C, TG, and apo A-1.
Both treatment regimens were safe and well-tolerated.
McKenney J, Jones M, Abby S. Safety and efficacy of colesevelam hydrochloride in combination with fenofibrate for the treatment
of mixed hyperlipidemia. Curr Med Res Opin. 2005; 21:1403–1412.