| Safety and efficacy of colesevelam hydrochloride in combination with fenofibrate for the treatment of mixed hyperlipidemia. | |
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MedLine Citation:
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PMID: 16197659 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: The aim of this study was to evaluate the amount of low-density lipoprotein cholesterol (LDL-C) reduction achieved by adding the specifically engineered bile acid sequestrant (SE-BAS) colesevelam HCl to a stable dose of fenofibrate in patients with mixed hyperlipidemia. RESEARCH DESIGN AND METHODS: Patients with mixed hyperlipidemia (n = 129) were enrolled in a randomized, double-blind, placebo-controlled, parallel-group study investigating the efficacy of fenofibrate plus colesevelam HCl versus fenofibrate monotherapy. After a 4- to 8-week washout period, subjects received fenofibrate 160 mg/day for 8 weeks and were then randomized to receive colesevelam HCl 3.75 g/day or placebo, in addition to fenofibrate 160 mg/day, for 6 weeks. MAIN OUTCOMES MEASURES: The primary efficacy endpoint was mean percent change in LDL-C during randomized treatment. Secondary endpoints included absolute and percent changes in mean levels of LDL-C, triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol (TC), and apolipoproteins (apo) A-I and B during randomized treatment and from washout to end of randomized treatment. RESULTS: Of the 129 patients randomized to treatment, 119 completed the study. After 6 weeks of treatment, fenofibrate plus colesevelam HCl produced a mean percent change in LDL-C of -10.4% versus +2.3% with fenofibrate monotherapy (p < 0.0001). Fenofibrate plus colesevelam HCl was significantly more effective than fenofibrate alone at reducing levels of non-HDL-C, TC, and apo B (p < or = 0.0002). Colesevelam HCl did not significantly affect the TG-lowering effects of fenofibrate. Both treatment regimens were safe and well tolerated. CONCLUSIONS: Compared with fenofibrate monotherapy in patients with mixed hyperlipidemia, fenofibrate/colesevelam HCl combination therapy significantly reduced mean LDL-C, non-HDL-C, TC, and apo B levels without significantly affecting the TG-lowering or HDL-C-raising effects of fenofibrate. Fenofibrate/colesevelam HCl combination therapy is a safe, useful alternative for the treatment of mixed hyperlipidemia. |
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Authors:
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James McKenney; Michael Jones; Stacey Abby |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Current medical research and opinion Volume: 21 ISSN: 0300-7995 ISO Abbreviation: Curr Med Res Opin Publication Date: 2005 Sep |
Date Detail:
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Created Date: 2005-10-03 Completed Date: 2005-10-28 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0351014 Medline TA: Curr Med Res Opin Country: England |
Other Details:
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Languages: eng Pagination: 1403-12 Citation Subset: IM |
Affiliation:
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National Clinical Research, Inc., Richmond, VA 23294, USA. jmckenney@ncrinc.net |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Allylamine
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administration & dosage,
adverse effects,
analogs & derivatives*,
therapeutic use Antilipemic Agents / administration & dosage, adverse effects, therapeutic use* Double-Blind Method Drug Therapy, Combination Female Humans Hyperlipoproteinemia Type V / drug therapy* Male Middle Aged Procetofen / administration & dosage, adverse effects, therapeutic use* Safety Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antilipemic Agents; 107-11-9/Allylamine; 182815-44-7/colesevelam; 49562-28-9/Procetofen |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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