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Clinical effects of colesevelam in hispanic subjects with primary hyperlipidemia and prediabetes
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Autores
Rosenstock, Julio
Hernandez-Triana, Eric
Handelsman, Yehuda
Misir, Soamnauth
Jones, Michael R.
Fecha
2012
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Medquest Communications LLC
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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 less than 125 mg/dL, or 2-hour postload glucose level > 140 to less than 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-identifed as Hispanic during enrollment were included in this exploratory analysis evaluating the effcacy 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 less than 0.0001). Achievement of LDL-C level less than 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 less than 0.0002 for all), and a significant median increase in triglyceride levels (P = 0.003), were seen with colesevelam compared with placebo. At study end, there was a significant mean reduction in glycated hemoglobin levels and median reduction in fasting plasma glucose levels with colesevelam compared with placebo (P less than 0.02 for both). A fasting plasma glucose level less than 100 mg/dL was achieved in 44% of colesevelam recipients compared with 23% of placebo recipients (P less than 0.05). Overall, colesevelam was well tolerated. Conclusion: Colesevelam may be a treatment option for Hispanic subjects with primary hyperlipidemia and prediabetes, mainly to reduce LDL-C levels, with added beneficial effect on glucose levels. © Postgraduate Medicine.
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Keywords
Apolipoprotein B , Glycosylated , Glucose , Hemoglobin a1c , Low density lipoprotein cholesterol , Placebo , Allylamine , Apolipoprotein B , Colesevelam , Drug derivative , Glycosylated hemoglobin , High density lipoprotein , Hypocholesterolemic agent , Low density lipoprotein cholesterol , Abdominal pain , Adult , Article , Backache , Cholesterol blood level , Clinical effectiveness , Clinical evaluation , Constipation , Controlled study , Diarrhea , Dizziness , Double blind procedure , Drug effect , Drug efficacy , Drug safety , Drug tolerability , Dyspepsia , Female , Glucose blood level , Glycemic control , Headache , Hemoglobin blood level , Hispanic , Human , Hyperlipidemia , Hypertension , Impaired glucose tolerance , Influenza , Major clinical study , Male , Multicenter study , Nausea , Primary hyperlipidemia , Protein blood level , Randomized controlled trial , Treatment duration , Treatment planning , Upper abdominal pain , Blood , Clinical trial , Controlled clinical trial , Ethnology , Hispanic , Treatment outcome , Allylamine , Anticholesteremic Agents , Apolipoproteins B , Blood Glucose , Cholesterol , Double-Blind Method , Female , Hemoglobin A , Hispanic Americans , Humans , Hyperlipidemias , Lipoproteins , Male , Prediabetic State , Treatment Outcome , Colesevelam , Hispanic , Hyperlipidemia , Prediabetes
