勃林格-礼来在美国推出糖尿病复方新药Glyxambi

2015年3月23日讯/生物谷BIOON/--勃林格-礼来糖尿病联盟近日联合在美国推出糖尿病复方新药Glyxambi，该药是首个双效抑制剂降糖药，由已上市药物Jardiance（empagliflozin，一种钠-葡萄糖联合转运体-2（SGLT2）抑制剂）和Trajenta（linagliptin，一种二肽基肽酶-4抑制剂（DPP-4））组成。FDA于今年2月批准Glyxambi作为每日一次的口服药物，辅助饮食和运动用于改善2型糖尿病成人患者的血糖控制。Glyxambi是一种每日一次的片剂，在每天早上服药，该药由10mg或25mgSGLT2抑制剂empagliflozin和5mgDPP-IV抑制剂linagliptin组成。Glyxambi不适用于1型糖尿病或糖尿病酮症酸中毒的治疗。
empagliflozin属于钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂类药物，开发用于2型糖尿病成人患者的治疗。新兴的SGLT-2抑制剂类药物，已被证实能够阻断肾脏中葡萄糖的再吸收作用，将过多的葡萄糖通过尿液排泄到体外，从而达到降低血糖水平的效果，而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。
linagliptin则属于二肽基肽酶-4（DPP-4）抑制剂类药物，可刺激刺激胰腺分泌更多的胰岛素，并刺激肝脏产生更少的葡萄糖。目前，linagliptin已在美国上市，品牌名为Tradjenta，作为每日一次的药物，结合饮食和运动改善2型糖尿病成人患者的血糖控制。
Glyxambi是首个将这2种具独特作用机制的药物合并至单一片剂的复方新药，该药也是勃林格-礼来糖尿病联盟联合开发的重要产品之一。
英文原文：First-in-classtype2diabetestreatmentGlyxambi?(empagliflozin/linagliptin)tabletsforadultsnowavailableinU.S.pharmacies
NewdualinhibitorSGLT2/DPP-4combinationtherapyoffersimprovedglycemiccontrolasanadjuncttodietandexercise
NewGLYXAMBIsavingsprogramofferedforeligiblepatients
RIDGEFIELD,Conn.,andINDIANAPOLIS,March23,2015/PRNewswire/--Glyxambi?(empagliflozin/linagliptin)tabletsarenowavailablebyprescriptioninmanyleadingchainandindependentpharmaciesacrosstheU.S.,includingWalgreensandRiteAid.GLYXAMBI,partoftheBoehringerIngelheimPharmaceuticals,Inc.(BIPI)andEliLillyandCompany(LLY)Diabetesallianceportfolio,isthefirstandonlydualinhibitorcombinationtherapyapprovedintheU.S.tocombinethemechanismsofactionofasodiumglucoseco-transporter-2(SGLT2)inhibitorandadipeptidylpeptidase-4(DPP-4)inhibitorinaonce-dailytablet.
GLYXAMBIisapprovedasanadjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetes(T2D)whenbothempagliflozinandlinagliptinareappropriatetreatments.GLYXAMBIisaonce-dailytablettakeninthemorningthatcombines10mgor25mgofempagliflozin,anSGLT2inhibitor,with5mgoflinagliptin,aDPP-4inhibitor.GLYXAMBIisnotforpeoplewithtype1diabetesorfordiabeticketoacidosis(increasedketonesinthebloodorurine).Ifyouhavehadpancreatitis(inflammationofthepancreas)itisnotknownifyouhaveahigherchanceofgettingpancreatitiswhiletakingGLYXAMBI.
"TherapidmarketavailabilityofGLYXAMBIfollowingitsrecentFDAapprovalinlateJanuaryisareflectionofBoehringerIngelheimandLillyscommitmenttobringingnewtreatmentoptionstopeoplewithtype2diabetes,"saidKathleenDowd,seniorvicepresident,marketing,BoehringerIngelheimPharmaceuticals,Inc."AsthefourthdiabetesmedicinetoemergefromouralliancepipelineintheU.S.,webelieveGLYXAMBImayhelpadultswithtype2diabeteslowertheirbloodsugarandmanagetheirdiabetes."
AGLYXAMBIsavingscardprogramisavailableonlineandinmanydoctorsofficesforpatientswhoqualify.Fortermsandconditionsandanyquestionsregardingeligibilityorbenefits,visitGLYXAMBIsavings.comorcall1-855-GLYXAMBI(1-855-459-9262).
GLYXAMBIshouldnotbetakenifyouhaveseverekidneyproblems,areondialysisorifyouareallergictoempagliflozinandlinagliptinoranyoftheingredientsinGLYXAMBI.SymptomsofaseriousallergicreactiontoGLYXAMBImayincludeskinrash,itching,flakingorpeeling;raisedredpatchesonyourskin(hives);difficultyswallowingorbreathing;orswellingofyourface,lips,tongue,andthroatthatmaycausedifficultybreathingorswallowing.Ifyouhaveanyofthesesymptoms,stoptakingGLYXAMBIandcallyourdoctororgototheemergencyroomrightaway.
"Asanadd-ontometformin,GLYXAMBIwassuperiorinreducingA1Cwhencomparedwitheitherempagliflozinorlinagliptinalone,"saidDavidKendall,M.D.,vicepresident,medicalaffairs,LillyDiabetes."Themanagementoftype2diabetesrequiresapersonalizedtreatmentplan,andGLYXAMBIprovidespatientsandtheirphysicianswithanewoptiontohelpimprovebloodsugarcontrol."
TheU.S.FoodandDrugAdministrationapprovalwasbasedonaphaseIIIclinicaltrialthatevaluatedtheefficacyandsafetyofGLYXAMBI(10/5mgand25/5mg)comparedwiththeindividualcomponentsofempagliflozin(10mgor25mg)orlinagliptin(5mg)inadultswithT2Dwhowerealsotakinghigh-dosemetformin(meandose1889mgdaily).Thestudy,whichrandomized686adultswithT2DandhemoglobinA1C(ameasureofaveragebloodglucoseoverthepasttwotothreemonths)between7.0and10.5percent,examinedthechangefrombaselineinA1Cat24weeks.ThestudydemonstratedsuperiorA1CreductionwithGLYXAMBIcomparedwiththeindividualcomponentsofempagliflozinorlinagliptin.Startingfromameanbaselineofapproximately8.0percent,adultsinthistrialachievedameanA1Cof6.9and6.7percentwithGLYXAMBI10/5mgand25/5mg,respectively,comparedwithameanA1Cof7.3and7.4percentforempagliflozin10mgand25mg,respectively,and7.3percentforlinagliptin5mg.
DatarecentlypublishedinDiabetesCaredemonstratedthat58percentand62percentofpatientstakingGLYXAMBI10/5mgor25/5mg,respectively,inadditiontometforminachievedanA1Coflessthan7percentfromabaselineA1Cofapproximately8percent,comparedwith28percentofpatientstakingempagliflozin10mg,33percenttakingempagliflozin25mgand36percenttakinglinagliptin5mg.
Through52weeks,thesafetyprofileofGLYXAMBIwasdemonstratedinapooledanalysis,andthemostcommonadversereactionswereurinarytractinfection(UTI)(12.5percentand11.4percentforGLYXAMBI10/5mgand25/5mg,respectively;through52weeks,nopatientdiscontinuedGLYXAMBIduetoUTIs),nasopharyngitis(5.9percentand6.6percentforGLYXAMBI10/5mgand25/5mg,respectively)andupperrespiratorytractinfection(7.0percentforGLYXAMBI10/5mgand25/5mg).
SerioussideeffectscanhappentopeopletakingGLYXAMBI,includinginflammationofthepancreas(pancreatitis),whichmaybesevereandleadtodeath.BeforeyoustarttakingGLYXAMBI,tellyourdoctorifyouhaveeverhadpancreatitis,gallstones,ahistoryofalcoholism,orhightriglyceridelevels.StoptakingGLYXAMBIandcallyourdoctorrightawayifyouhavepaininyourstomacharea(abdomen)thatissevereandwillnotgoaway.Thepainmaybefeltgoingfromyourabdomentoyourback.Thepainmayhappenwithorwithoutvomiting.Thesemaybesymptomsofpancreatitis.
WhatisGLYXAMBI?GLYXAMBIisaprescriptionmedicinethatcontains2diabetesmedicines,empagliflozinandlinagliptin.GLYXAMBIcanbeusedalongwithdietandexercisetolowerbloodsugarinadultswithtype2diabeteswhentreatmentwithbothempagliflozinandlinagliptinisappropriate.
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