Clinical effects of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes.

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Rosenstock J, Hernandez-Triana E, Handelsman Y, Misir S, Jones MR

Clinical effects of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes.

Postgrad Med. 2012 Jul;124(4):14-20. doi: 10.3810/pgm.2012.07.2564.

PubMed ID

22913890 [ View in PubMed

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Abstract

OBJECTIVE: To evaluate the efficacy and safety of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes. MATERIALS AND METHODS: A 16-week, randomized, double-blind, placebo-controlled, multinational study evaluating colesevelam in participants with primary hyperlipidemia (low-density lipoprotein cholesterol [LDL-C] level >/= 100 mg/dL) and prediabetes (fasting plasma glucose level >/= 110 to /= 140 to < 200 mg/dL during an oral glucose tolerance test) was conducted between January 14, 2008 and April 3, 2009. Participants were randomized 1:1 to colesevelam 3.75 g/day or placebo. The primary efficacy endpoint was mean change from baseline in LDL-C level with colesevelam compared with placebo. Participants who self-identified as Hispanic during enrollment were included in this exploratory analysis evaluating the efficacy of colesevelam in Hispanics with primary hyperlipidemia and prediabetes. RESULTS: From a total of 216 subjects with primary hyperlipidemia and prediabetes, 153 Hispanics were included in this post hoc analysis; 77 subjects were randomized to colesevelam and 76 subjects were randomized to placebo. At week 16, LDL-C levels were significantly reduced with colesevelam compared with placebo (mean treatment difference, -19.4%; P < 0.0001). Achievement of LDL-C level < 100 mg/dL was more frequent with colesevelam than with placebo (27% vs 11%; P = 0.002). In addition, significant mean reductions in non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein B levels (P

DrugBank Data that Cites this Article

Pharmaco-metabolomics

Drug	Drug Groups	Metabolite	Change	Description
Colesevelam	Approved	Triglycerides	increased	Colesevelam increases the level of Triglycerides in the blood
Colesevelam	Approved	Total cholesterol	decreased	Colesevelam decreases the level of Total cholesterol in the blood
Colesevelam	Approved	LDL cholesterol	decreased	Colesevelam decreases the level of LDL cholesterol in the blood
Colesevelam	Approved	Non-HDL cholesterol	decreased	Colesevelam decreases the level of Non-HDL cholesterol in the blood