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Initial combination therapy with metformin plus colesevelam improves lipoprotein particles in patients with early type 2 diabetes mellitus

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dc.creatorGoldberg, Ronald B.spa
dc.creatorRosenson, Robert S.spa
dc.creatorHernandez-Triana, Ericspa
dc.creatorMisir, Soamnauthspa
dc.creatorJones, Michael R.spa
dc.date.accessioned2020-05-25T23:56:02Z
dc.date.available2020-05-25T23:56:02Z
dc.date.created2012spa
dc.description.abstractBackground: 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.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1016/j.jacl.2012.05.005
dc.identifier.issn19332874
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/22299
dc.language.isoengspa
dc.relation.citationEndPage324
dc.relation.citationIssueNo. 4
dc.relation.citationStartPage318
dc.relation.citationTitleJournal of Clinical Lipidology
dc.relation.citationVolumeVol. 6
dc.relation.ispartofJournal of Clinical Lipidology, ISSN:19332874, Vol.6, No.4 (2012); pp. 318-324spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84864216037&doi=10.1016%2fj.jacl.2012.05.005&partnerID=40&md5=bf1e8ed8e877df4773a44cffb9164943spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordApolipoprotein Bspa
dc.subject.keywordCombinationeng
dc.subject.keywordColesevelamspa
dc.subject.keywordHemoglobin a1cspa
dc.subject.keywordHigh density lipoprotein cholesterolspa
dc.subject.keywordLipoproteinspa
dc.subject.keywordLow density lipoprotein cholesterolspa
dc.subject.keywordMetforminspa
dc.subject.keywordPlacebospa
dc.subject.keywordTriacylglycerolspa
dc.subject.keywordVery low density lipoproteinspa
dc.subject.keywordAdultspa
dc.subject.keywordArticlespa
dc.subject.keywordCholesterol blood levelspa
dc.subject.keywordControlled studyspa
dc.subject.keywordCorrelational studyspa
dc.subject.keywordDouble blind procedurespa
dc.subject.keywordDrug dose increasespa
dc.subject.keywordDrug dose titrationspa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordEvening dosagespa
dc.subject.keywordFemalespa
dc.subject.keywordHemoglobin blood levelspa
dc.subject.keywordHumanspa
dc.subject.keywordLipoprotein blood levelspa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordMalespa
dc.subject.keywordMorning dosagespa
dc.subject.keywordMulticenter studyspa
dc.subject.keywordNon insulin dependent diabetes mellitusspa
dc.subject.keywordOpen studyspa
dc.subject.keywordPriority journalspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordTreatment durationspa
dc.subject.keywordTriacylglycerol blood levelspa
dc.subject.keywordAdultspa
dc.subject.keywordAllylaminespa
dc.subject.keywordAnticholesteremic Agentsspa
dc.subject.keywordApolipoprotein A-Ispa
dc.subject.keywordApolipoproteins Bspa
dc.subject.keywordCholesteroleng
dc.subject.keywordCholesteroleng
dc.subject.keywordDiabetes Mellituseng
dc.subject.keywordDouble-Blind Methodspa
dc.subject.keywordDrug Administration Schedulespa
dc.subject.keywordDrug Therapyeng
dc.subject.keywordFemalespa
dc.subject.keywordHemoglobin Aeng
dc.subject.keywordHumansspa
dc.subject.keywordHyperlipidemiasspa
dc.subject.keywordLipoproteinseng
dc.subject.keywordMalespa
dc.subject.keywordMetforminspa
dc.subject.keywordMiddle Agedspa
dc.subject.keywordPlacebo Effectspa
dc.subject.keywordTriglyceridesspa
dc.subject.keywordApolipoproteinspa
dc.subject.keywordBile acid sequestrantspa
dc.subject.keywordColesevelamspa
dc.subject.keywordLipoprotein particlesspa
dc.subject.keywordLow-density lipoproteinspa
dc.subject.keywordType 2 diabetes mellitusspa
dc.titleInitial combination therapy with metformin plus colesevelam improves lipoprotein particles in patients with early type 2 diabetes mellitusspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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