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Initial combination therapy with metformin plus Colesevelam in drug-naïve hispanic patients with early type 2 diabetes
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Rosenstock, Julio
Hernandez-Triana, Eric
Handelsman, Yehuda
Misir, Soamnauth
Jones, Michael R.
Nagendran, Sukumar
Fecha
2012
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Medquest Communications LLC
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Abstract
Objective: To evaluate initial combination therapy with metformin plus colesevelam in drug-naïve Hispanic patients with type 2 diabetes mellitus. Research Design and Methods: Patients self-identifed as Hispanic from a previous study were included in this exploratory post hoc analysis. Patients were randomized to metformin plus colesevelam or metformin plus placebo. The primary effcacy parameter was the mean change in glycated hemoglobin (HbA1c) levels from baseline. Results: Metformin plus colesevelam had a greater mean HbA1c reduction (-1.2 ± 0.1%) than metformin plus placebo (-0.8 ± 0.1%; P = 0.001) from mean baselines of 7.7% and 7.6%, respectively. Low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein (apo) B levels were also reduced (P and lt; 0.0001 for all), while triglyceride (P and lt; 0.0001) and apoA-I (P and lt; 0.05) levels were increased with metformin plus colesevelam treatment compared with metformin plus placebo. With metformin plus colesevelam versus metformin plus placebo, more patients achieved an HbA1c of, 7.0% (75% vs 56%) and LDL-C of, 100 mg/dL (49% vs 14%; both P, 0.05). Conclusion: Metformin plus colesevelam may be an effective initial treatment option for Hispanic patients with early type 2 diabetes mellitus. © Postgraduate Medicine.
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Keywords
Apolipoprotein A1 , Type 2 , Colesevelam , Hemoglobin a1c , Low density lipoprotein cholesterol , Metformin , Placebo , Triacylglycerol , Allylamine , Antidiabetic agent , Cholesterol , Colesevelam , Drug derivative , Glycosylated hemoglobin , Hypocholesterolemic agent , Lipoprotein , Metformin , Abdominal distension , Abdominal pain , Adult , Article , Cholesterol blood level , Cohort analysis , Constipation , Controlled study , Diarrhea , Drug dose titration , Drug efficacy , Drug response , Drug safety , Drug withdrawal , Dyspepsia , Female , Flatulence , Gastritis , Hispanic , Human , Major clinical study , Male , Multicenter study (topic) , Nausea , Non insulin dependent diabetes mellitus , Post hoc analysis , Randomized controlled trial (topic) , Triacylglycerol blood level , Vomiting , Blood , Clinical trial , Controlled clinical trial , Double blind procedure , Drug combination , Ethnology , Hispanic , Randomized controlled trial , Treatment outcome , Allylamine , Anticholesteremic Agents , Cholesterol , Diabetes Mellitus , Double-Blind Method , Drug Therapy , Female , Hemoglobin A , Hispanic Americans , Humans , Hypoglycemic Agents , Lipoproteins , Male , Metformin , Treatment Outcome , Bile acid sequestrant , Colesevelam , Hispanic , Metformin , Type 2 diabetes mellitus
