Ítem
Solo Metadatos

Clinical effects of colesevelam in hispanic subjects with primary hyperlipidemia and prediabetes

Mostrar el registro sencillo de la publicación
dc.creatorRosenstock, Juliospa
dc.creatorHernandez-Triana, Ericspa
dc.creatorHandelsman, Yehudaspa
dc.creatorMisir, Soamnauthspa
dc.creatorJones, Michael R.spa
dc.date.accessioned2020-05-25T23:58:22Z
dc.date.available2020-05-25T23:58:22Z
dc.date.created2012spa
dc.description.abstractObjective: 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.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.3810/pgm.2012.07.2564
dc.identifier.issn325481
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/22848
dc.language.isoengspa
dc.publisherMedquest Communications LLCspa
dc.relation.citationEndPage20
dc.relation.citationIssueNo. 4
dc.relation.citationStartPage14
dc.relation.citationTitlePostgraduate Medicine
dc.relation.citationVolumeVol. 124
dc.relation.ispartofPostgraduate Medicine, ISSN:325481, Vol.124, No.4 (2012); pp. 14-20spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84871699451&doi=10.3810%2fpgm.2012.07.2564&partnerID=40&md5=83cc0d72a003f1d86ea159230f73053espa
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.keywordGlycosylatedeng
dc.subject.keywordGlucosespa
dc.subject.keywordHemoglobin a1cspa
dc.subject.keywordLow density lipoprotein cholesterolspa
dc.subject.keywordPlacebospa
dc.subject.keywordAllylaminespa
dc.subject.keywordApolipoprotein Bspa
dc.subject.keywordColesevelamspa
dc.subject.keywordDrug derivativespa
dc.subject.keywordGlycosylated hemoglobinspa
dc.subject.keywordHigh density lipoproteinspa
dc.subject.keywordHypocholesterolemic agentspa
dc.subject.keywordLow density lipoprotein cholesterolspa
dc.subject.keywordAbdominal painspa
dc.subject.keywordAdultspa
dc.subject.keywordArticlespa
dc.subject.keywordBackachespa
dc.subject.keywordCholesterol blood levelspa
dc.subject.keywordClinical effectivenessspa
dc.subject.keywordClinical evaluationspa
dc.subject.keywordConstipationspa
dc.subject.keywordControlled studyspa
dc.subject.keywordDiarrheaspa
dc.subject.keywordDizzinessspa
dc.subject.keywordDouble blind procedurespa
dc.subject.keywordDrug effectspa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug safetyspa
dc.subject.keywordDrug tolerabilityspa
dc.subject.keywordDyspepsiaspa
dc.subject.keywordFemalespa
dc.subject.keywordGlucose blood levelspa
dc.subject.keywordGlycemic controlspa
dc.subject.keywordHeadachespa
dc.subject.keywordHemoglobin blood levelspa
dc.subject.keywordHispanicspa
dc.subject.keywordHumanspa
dc.subject.keywordHyperlipidemiaspa
dc.subject.keywordHypertensionspa
dc.subject.keywordImpaired glucose tolerancespa
dc.subject.keywordInfluenzaspa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordMalespa
dc.subject.keywordMulticenter studyspa
dc.subject.keywordNauseaspa
dc.subject.keywordPrimary hyperlipidemiaspa
dc.subject.keywordProtein blood levelspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordTreatment durationspa
dc.subject.keywordTreatment planningspa
dc.subject.keywordUpper abdominal painspa
dc.subject.keywordBloodspa
dc.subject.keywordClinical trialspa
dc.subject.keywordControlled clinical trialspa
dc.subject.keywordEthnologyspa
dc.subject.keywordHispanicspa
dc.subject.keywordTreatment outcomespa
dc.subject.keywordAllylaminespa
dc.subject.keywordAnticholesteremic Agentsspa
dc.subject.keywordApolipoproteins Bspa
dc.subject.keywordBlood Glucosespa
dc.subject.keywordCholesteroleng
dc.subject.keywordDouble-Blind Methodspa
dc.subject.keywordFemalespa
dc.subject.keywordHemoglobin Aeng
dc.subject.keywordHispanic Americansspa
dc.subject.keywordHumansspa
dc.subject.keywordHyperlipidemiasspa
dc.subject.keywordLipoproteinseng
dc.subject.keywordMalespa
dc.subject.keywordPrediabetic Statespa
dc.subject.keywordTreatment Outcomespa
dc.subject.keywordColesevelamspa
dc.subject.keywordHispanicspa
dc.subject.keywordHyperlipidemiaspa
dc.subject.keywordPrediabetesspa
dc.titleClinical effects of colesevelam in hispanic subjects with primary hyperlipidemia and prediabetesspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
Archivos
Colecciones
Artículos