Effects of colesevelam hydrochloride (WelChol) on biomarkers of inflammation in patients with mild hypercholesterolemia.
Inflammation is pivotal in atherogenesis. High-sensitivity C-reactive protein (hs-CRP), the prototypic marker of inflammation, has been shown to predict cardiovascular events. Colesevelam hydrochloride (HCl) (WelChol, Sankyo Pharma Incorporated, Parsippany, New Jersey), a specifically engineered bile acid sequestrant, has been shown to be effective in lowering low-density lipoprotein (LDL) cholesterol levels in monotherapy and in combination with statins or fenofibrate. Previously, we have shown that statins lower hs-CRP levels; however, a paucity of data is available examining the effect of colesevelam HCl on hs-CRP levels. The aim of this study was to examine the effect of colesevelam HCl therapy (3.75 g/day for 6 weeks) on hs-CRP in patients with mild hypercholesterolemia in a randomized, double-blind, placebo-controlled study. Twenty-five subjects on colesevelam HCl and 23 subjects on placebo completed the study. The median baseline hs-CRP levels for the treatment and placebo groups are 3.4 and 3.1 mg/L, respectively. Colesevelam HCl therapy resulted in a significant reduction in LDL cholesterol levels (p < 0.001). No significant changes were found in total triglyceride or high-density lipoprotein cholesterol levels between the 2 groups. Furthermore, colesevelam HCl therapy resulted in a significant reduction in hs-CRP levels compared with baseline and placebo (15.9% and 18.7% median reduction, respectively, p < 0.025). No correlation was found between LDL cholesterol lowering and hs-CRP lowering (r = 0.3). In conclusion, our results show that colesevelam HCl monotherapy significantly lowered hs-CRP levels in a double-blind, placebo-controlled study.
Devaraj
Sridevi
S
Laboratory for Atherosclerosis and Metabolic Research, University of California, Davis, Medical Center, Sacramento, California, USA.
Autret
Bryce
B
Jialal
Ishwarlal
I
D000328:Adult; D000499:Allylamine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism*; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D000069472:Colesevelam Hydrochloride; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007249:Inflammation / Q000097:blood*; D016896:Treatment Outcome
D015415:Biomarkers; D008078:Cholesterol, LDL; D000499:Allylamine; D002097:C-Reactive Protein; D000069472:Colesevelam Hydrochloride