6533b7d6fe1ef96bd1265b02
RESEARCH PRODUCT
Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes
Green JbBethel MaArmstrong PwBuse JbEngel SsGarg JJosse RKaufman KdKoglin JKorn SLachin JmMcguire DkPencina MjStandl EStein PpSuryawanshi SVan De Werf FPeterson EdHolman RrHolman RrPeterson EdHolman RrPeterson EdArmstrong PwBuse JbJosse RgKaufman KdKoglin JKorn SLachin JmMcguire DkStandl EStein PpSuryawanshi SVan De Werf FEngel SsCaliff RmGoldstein BjShapiro DrSilverman RBethel AGreen JHayden SHannan KQuintero KRorick TBerdan LLeloudis DCaliff SWilson MMcfarron DTrollinger KPesarchick JEskenazi LCampbell CTownes OTolsma DKeenan JMilton JAthwal RDarbyshire JDoran ZKennedy IGregory VGarg JLokhnygina YPrather KWolfley AUsman MTajjar AGray RPfeffer MaGerstein HcGroop LMcmurray JjPocock SjClayton TSinay IBrieger DStranks SScheen ALopes RTankova THramiak IGrado CrWenying YGe JAschner PSkrha JAmbos AStrandberg TTravert FHanefeld MRiefflin AChan JcOfner PReddy NkChristopher JMathur AArambam PMittal SManchanda MWainstein JAmbrosio GPirags VJakuboniene NMohamed MScott RWhite HCornel JHalvorsen STykarski AVeresiu IaDreval AvMisinkova ITai EKrahulec BDistiller LPark YRovira AAlversson MChuang LmDelibasi TAdler ARodbard HwMarre MGoff DChacra ADevore ABeaven AShah BHirsch BBatch BBushnell CPatel CMelloni CHenshaw CKong DMcfarron DBernecki GTillman HKang HjGreen JHawes JStrickler JPiccini JWilder JAlexander KMahaffey KPatel KHyland KNewby KJackson LCooper LArmaganijan LSzczeh LKoshizaka MRoe MMorse MGuimaraes PHess PTricoci PMehta RLopes RMathews RKociol RHarrison RMentz RPokorney SLeblanc TLazzarini VEapen ZTruffa AFosbol EBrito FKatz MBahit MSantos MBarros PBernardez SAlvarisqueta AfArias PCagide AlCalella PrCantero McCanella JpCipullo MaDe Loredo LGelersztein EsGorban De Lapertosa SbKlyver MiMaffei LeMaldonado NOviedo AiPiskorz DlRidruejo McSaavedra SsSessa HaSinay IrSposetti GdUlla MrVico MlWaitman JnBinnekamp MCarroll PCheung WColman PDavis TDe Looze FDemden MFulcher GGerstman MHamilton ALehman SMoses RProietto JRoberts AShaw JSimpson RSinha AStranks STan YTopliss DVora PWaites JCrenier LDescamps OKeymeulen BMathieu CNobels FScheen AVan Den Bruel AVan Gaal LBorges JlCosta E Forti AEliaschewitz FgFelício JsGriz LhHissa MnLeite SPanarotto DPimentel Filho PRassi NSaraiva JkSgarbi JaSilva RpTambascia MWeber Silva DmBobeva RBostandzhieva RCinlikov IGeorgieva MIliev DIlieva EKovacheva SLiubenova LNikitov ZSheinikova GSlavcheva ASpasova VTankova TTemelkova-kurktschiev TVelichka DYakov ACarpentier AChiasson JlConstance CDumas RFilteau PGarceau CHramiak IHuynh TKaiser SKornder JLeiter LMereu LMiller DPandey SPunthakee ZRabasa-lhoret RRobitaille YSaunders KSigal RSigalas JVizel SWeisnagel SWoo VYale JfYared KZinman BBunster Balocchi LbEscobar Cerda EeGarces Flores EeLanas Zanetti FtLarrazabal Miranda Adel PMorales Alvarado JmOlivares Cañon CmPotthoff Cárdenas ShRaffo Grado CaRodriguez Venegas MeSaavedra Gajardo VaWesterberg Maldonado BhChen LlDong JGuo XLi QmShi BTang XlYang TYang WyZheng SxAschner Montoya PBotero Lopez RCoronel Arroyo JaCure CaGómez Medina AmMolina DiPerez Amador GaReyes Rincon AUrina Triana MaValenzuela Rincon AVélez Pelaez SYupanqui Lozno HBrabec TBrychta THasalova Zapletalova JHavelkova JHejnicova KHola OHornackova MHrdina TKafkova DKellnerova IKrystl TKutejova VMikulkova INevrla JPantlikova CPetr MRacicka ESarbochova RSkrha JSmolenakova KTurcinek RUrbancova KVejvodova JVondrakova MZachoval RAlt IAmbos AKaasik ÜKiiroja KLanno RMärtsin KPast MVides HViitas LKantola INieminen SPerhonen MStrand JStrandberg TValle TClergeot ACouffinhal TCourreges JpGouet DMoulin PTravert FZiegler OBadenhoop KBehnke TBender GBraun MDshabrailov JHamann AHanefeld MHimpel-boenninghoff AKamke WKasperk CLuedemann JMayr PMerkel MOerter EmOhlow MaOtt POverhoff UPaschen BRemppis RRiefflin ARose LSchumm-draeger PmSegiet TStrotmann HjStuchlik GStürmer WThinesse-mallwitz MTytko AWendisch UWurziger JHo AyKam GKong ApLam YyLau EyLee SSiu ScTomlinson BTsang CcYeung VtDezső EDudás MFöldesi IFülöp TKésmárki NKoranyi LNagy KOfner POroszlán TPécsvárady ZPles ZTaller AAgarwal PAmbulkar SAravind SBalaji VChristopher JKalra SKesavadev JKudalkar HKumar AMisra AMithal AMohan VPitale SRamu MReddy NShah SShamanna PSharda ASharma AShunmugavelu MSrikanta SSuryaprakash GAbramov GAdawi FBashkin ADarawsha MFuchs SHarman-boehm IHayek TJaffe AKnobler HMinuchin OMosseri MShechter MShimon IStern NTsur AVishlitzky VWainstein JAlfonsi FCavalot FDel Vecchio LFrisinghelli AGambardella SLauro DLembo GLeotta SMondillo SNovo SPedrinelli RPiatti PSalvioni ATritto IZavaroni DzAhn KjChoi KmChung CHan SjKim DmKim IjKim MhLee IkNam MPark IebPark KsPark TsPark YRhee EjYoo SjAndersone IBalode AEglite RGersamija AKakurina NJegere BLeitane IPastare SPirags VStalte VTeterovska DBaltramonaitiene KBarsiene LCeponis JJakuboniene NLasiene JLevinger ASirutaviciene ASulskiene MUrbanaviciene LValius LVaranauskiene EVelickiene DMahendran KaAbu Hassan MrAziz NaHussein ZIsmail IsKamaruddin NaMohamed MNordin ZNayar SkRamanathan GrSothiratnam RBeijerbacht HBreedveld RCornel JhDen Hartog FHermans WKietselaer BKooy ALenderink TNierop PRemmen JRojas Lingan GRonner EVan Der Heijden RVan Hessen MVan Kempen WVoors-pette CWestendorp IBaker JBenatar JCutfield RKrebs JLeikis RLunt HManning PScott RWilliams MBirkeland KClaudi THalvorsen SIstad HKarlsson TOssum Gronert JArciszewska MArtemiuk EBlach EBlicharski TCypryk KDabrowska MGórny GGórska MJakubowska IJazwinska-tarnawska EKarczmarczyk AKitowska-koterla JKoltowski LKrzyzagorska EPasternak DPentela-nowicka JPiesiewicz WPrzekwas-jaruchowska MRajzer MSalamon-ferenc ASawicki ASkowron TŚMiałowski ATykarski AAlbota AAlexandru CCrisan CDumitrescu AFerariu IeLupusoru DaMunteanu MNegru DNicolau APintiliei EPopescu ASerban GVeresiu IaVoitec MBabenko ABarbarash OBondar IChizhov PDemin ADora SDreval AErshova OGratsiansky NKetova GKotelnikov MLevashov SMorugova TMustafina SPekarskiy SRaskina TRechkova ESamoylova YSazonova OSherenkov AShilkina NStetsyuk OTretyakova TTurova EValeeva FZadionchenko VDalan RTan RsTay LBuganova IFabry JJan CKrahulec BToserova EZak RZimanova JBadat ABester FBurgess LDe Jong DDistiller LEllis GFouche LGovender PGovind UNaidoo VNieuwoudt GNortje HRheeder PRobertson LSiddique NStapelberg AmTrinder YVan Der Merwe AVan Zyl LViljoen MWilhase ABotella MCiveira Murillo FDe Teresa LDel Cañizo FjExtremera BgGimeno EjMartin-hidalgo AMorales CNubiola ARovira ATinahones Madueño FTranche STrescolí Serrano CAlvarsson MEizyk EGillblad AJohansson PLöndahl MOhlsson-önerud ÅRautio ASundström UTorstensson IChen JfChou CwChuang LmHo LtHsieh IcHuang BhHuang ClHuang CnLai WtLo PhPei DSheu WhWang SyAraz MBakiner OComlekci ADelibasi TGuler SSahin ISarac FTarkun IUkinc KYilmaz MAbdulhakim EAbraham PAdamson KAdler ABlagden MBundy CDaly MDavies MDeshpande MGillings SHarvey PHorvathova VHorvathova VHristova DJaap AJohnson AJones HKerrane JKilvert AKo TKumar JLindsay RLitchfield JMccrimmon RMcknight JMillward BOyesile BPurewal TRavikumar CRobinson ASathyapalan TSimpson HThomas HTurner WWeaver JWilding JWiles PAdkins KAkpunonu BAlbu JAnagnostis GAnastasi LArgoud GAroda VAzizad MBanerji MaBartkowiak A JrBays HBehn PBergenstal RBhargava ABias DBolster EBuchanan PBusch RChadha CChang MCheng CCohen ACohen JCole BConnery LCooperman MCushman WDagostino RDavies MDayamani PDe Lemos JDe Meireles MDean JDehart DDetweiler RDonovan DDugano-daphnis PDulin MDunn FEaton CErickson BEstevez RFeinglos MFonseca VForce RForker AFox DGabriel JGarcia RGarvey TGaudiani LGetaneh AGoff DGoldberg AGoldman SHairston KHarris RHaught WHidalgo H JrHiggins AHouchin VIson RJacobs GJaffrani NJafry BKapsner PKaye WLabroo ALevinson LLewis SLillestol MLuttrell LMadu IMcneill RMerrick BMetzger FNadar VNagelberg SNash SOparil SOsei KPapademetriou VPatel NPedley CPrentiss ARadbill MRaisinghani ARassouli NReddy RRees PRendell MRobbins DRodbard HRohlf JRoseman HRudolph LSadler LSchnall ASchramm RSchubart USeneviratne TShanik MSnyder HSorli CStich MSweeney MeTsao JUkwade PViswanath DVo AVogel CVoyce SWeintraub HWhite JWood MWu PWysham CZimmerman Rsubject
Oralmedicine.medical_specialtyHeart diseasesGlycosylatedAdministration Oralheart failureType 2 diabetesDipeptidyl peptidase-4 inhibitorKaplan-Meier EstimatePlaceboSitagliptin PhosphateSitagliptin Cardiovascular Outcomeschemistry.chemical_compoundDrug TherapyDouble-Blind MethodInternal medicineDiabetes MellitusmedicineHumansHypoglycemic AgentsGlycated HemoglobinHemoglobin A GlycosylatedAdministration Oral; Cardiovascular Diseases; Diabetes Mellitus Type 2; Double-Blind Method; Drug Therapy Combination; Follow-Up Studies; Heart Diseases; Heart Failure; Hemoglobin A Glycosylated; Hospitalization; Humans; Hypoglycemic Agents; Kaplan-Meier Estimate; Pyrazines; Sitagliptin Phosphate; Triazoles; Medicine (all)business.industryMedicine (all)SemaglutideSitagliptin PhosphateHemoglobin AGeneral MedicineTriazolesta3121medicine.diseaseSurgeryHospitalizationCardiovascular diseaseschemistryDiabetes Mellitus Type 2SitagliptinPyrazinesAdministrationCombinationDrug Therapy CombinationGlycated hemoglobinbusinessType 2Alogliptinmedicine.drugFollow-Up Studiesdescription
BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to-0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P=0.98). There were no significant between-group differences in rates of acute pancreatitis (P=0.07) or pancreatic cancer (P=0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events. (Funded by Merck Sharp & Dohme; TECOS ClinicalTrials.gov number, NCT00790205.).
year | journal | country | edition | language |
---|---|---|---|---|
2015-07-16 | New England Journal of Medicine |