ColesevelamHClImprovesGlycemicControlandReducesLDLCholesterolinPatientsWithInadequatelyControlledType2DiabetesonSulfonylurea-BasedTherapy
http://care.diabetesjournals.org/cgi/content/abstract/31/8/1479
OBJECTIVE—Hyperglycemiaisariskfactorformicrovascularcomplicationsandmayincreasetheriskofcardiovasculardiseaseinpatientswithtype2diabetes.ThisstudytestedtheLDLcholesterol–loweringagentcolesevelamHCl(colesevelam)asapotentialnoveltreatmentforimprovingglycemiccontrolinpatientswithtype2diabetesonsulfonylurea-basedtherapy.
RESEARCHDESIGNANDMETHODS—A26-week,randomized,double-blind,placebo-controlled,parallel-group,multicenterstudywascarriedoutbetweenAugust2004andAugust2006toevaluatetheefficacyandsafetyofcolesevelamforreducingA1Cinadultswithtype2diabeteswhoseglycemiccontrolwasinadequate(A1C7.5–9.5%)withexistingsulfonylureamonotherapyorsulfonylureaincombinationwithadditionaloralanti-diabetesagents.Intotal,461patientswererandomized(230givencolesevelam3.75g/dayand231givenplacebo).Theprimaryefficacymeasurementwasmeanplacebo-correctedchangeinA1Cfrombaselinetoweek26intheintent-to-treatpopulation(lastobservationcarriedforward).
RESULTS—Theleastsquares(LS)meanchangeinA1Cfrombaselinetoweek26was–0.32%inthecolesevelamgroupand+0.23%intheplacebogroup,resultinginatreatmentdifferenceof–0.54%(P<0.001).TheLSmeanpercentchangeinLDLcholesterolfrombaselinetoweek26was–16.1%inthecolesevelamgroupand+0.6%intheplacebogroup,resultinginatreatmentdifferenceof–16.7%(P<0.001).FurThermore,significantreductionsinfastingplasmaglucose,fructosamine,totalcholesterol,non–HDLcholesterol,andapolipoproteinBweredemonstratedinthecolesevelamrelativetoplacebogroupatweek26.
CONCLUSIONS—ColesevelamimprovedglycemiccontrolandreducedLDLcholesterollevelsinpatientswithtype2diabetesreceivingsulfonylurea-basedtherapy.
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