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Goldberg, Ronald B. Rosenson, Robert S. Hernandez-Triana, Eric Misir, Soamnauth Jones, Michael R. 2020-05-25T23:56:02Z 2020-05-25T23:56:02Z 2012 Background: The bile acid sequestrant colesevelam has been shown to significantly reduce low-density lipoprotein particle concentration (LDL-P) in adults with primary hyperlipidemia or type 2 diabetes mellitus (T2DM). Objective: To assess the effect of initial combination therapy with metformin plus colesevelam on lipoprotein particles in patients with T2DM (secondary efficacy variables). Methods: This 16-week, randomized, double-blind, placebo-controlled study enrolled drug-naïve adults with T2DM, glycated hemoglobin 6.5%-10.0%, low-density lipoprotein cholesterol (LDL-C) ?100 mg/dL, and triglycerides less than 500 mg/dL. Patients were randomized 1:1 to either open-label metformin (titrated to 1700 mg/day) plus double-blind colesevelam 3.75 g/day or open-label metformin plus double-blind placebo. Results: In total, 286 patients were randomized (metformin plus colesevelam [n = 145]; metformin plus placebo [n = 141]). Compared with metformin plus placebo, the combination of metformin plus colesevelam significantly reduced LDL-C (mean treatment difference: -16.3%), total cholesterol (-6.1%), non-high-density lipoprotein cholesterol (-8.3%), and apolipoprotein (apo) B (-8.0%) and significantly increased triglycerides (median treatment difference: 18.6%) and apoA-I (mean treatment difference: 4.4%; all P less than .001). Metformin plus colesevelam significantly reduced total LDL-P (mean treatment difference: absolute change -186 nmol/L [percent change -11.7%]; both P less than .0001), largely attributable to a reduction in small LDL-P, and increased total very-low-density lipoprotein particle concentration (mean treatment difference: absolute change 6 nmol/L; P =.03 [percent change 8.3%; P =.06]) and total high-density lipoprotein particle concentration (1.0 ?mol/L; P =.03 [4.5%; P =.01]) versus metformin plus placebo. Conclusion: Initial combination therapy with metformin plus colesevelam improved the atherogenic lipoprotein profile of patients with early T2DM by significantly reducing LDL-P. ClinicalTrials.gov identifier: NCT00570739. © 2012 National Lipid Association. All rights reserved. application/pdf https://doi.org/10.1016/j.jacl.2012.05.005 19332874 https://repository.urosario.edu.co/handle/10336/22299 eng 324 No. 4 318 Journal of Clinical Lipidology Vol. 6 Journal of Clinical Lipidology, ISSN:19332874, Vol.6, No.4 (2012); pp. 318-324 https://www.scopus.com/inward/record.uri?eid=2-s2.0-84864216037&doi=10.1016%2fj.jacl.2012.05.005&partnerID=40&md5=bf1e8ed8e877df4773a44cffb9164943 info:eu-repo/semantics/openAccess Abierto (Texto Completo) instname:Universidad del Rosario reponame:Repositorio Institucional EdocUR Apolipoprotein B Chylomicron Colesevelam Hemoglobin a1c High density lipoprotein cholesterol Lipoprotein Low density lipoprotein cholesterol Metformin Placebo Triacylglycerol Very low density lipoprotein Adult Article Cholesterol blood level Controlled study Correlational study Double blind procedure Drug dose increase Drug dose titration Drug efficacy Evening dosage Female Hemoglobin blood level Human Lipoprotein blood level Major clinical study Male Morning dosage Multicenter study Non insulin dependent diabetes mellitus Open study Priority journal Randomized controlled trial Treatment duration Triacylglycerol blood level Adult Allylamine Anticholesteremic Agents Apolipoprotein A-I Apolipoproteins B Double-Blind Method Drug Administration Schedule Female Humans Hyperlipidemias Male Metformin Middle Aged Placebo Effect Triglycerides Apolipoprotein Bile acid sequestrant Colesevelam Lipoprotein particles Low-density lipoprotein Type 2 diabetes mellitus Combination Type 2 LDL LDL HDL Glycosylated Cholesterol Cholesterol Diabetes Mellitus Drug Therapy Hemoglobin A Lipoproteins Initial combination therapy with metformin plus colesevelam improves lipoprotein particles in patients with early type 2 diabetes mellitus article info:eu-repo/semantics/publishedVersion Artículo