6533b7d2fe1ef96bd125e387
RESEARCH PRODUCT
Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial.
O VaccaroM MasulliE BonoraS Del PratoCb GiordaAp MaggioniP MocarelliA NicolucciAa RivelleseS SquatritoG RiccardiT. O. S. C. A. It Study GroupG RiccardiE BonoraS Del PratoCb GiordaAp MaggioniP MocarelliA NicolucciCm SudS ImbaroAa RivelleseS SquatritoO VaccaroO VaccaroM MasulliN GarofaloE FerranniniB HowardE GerdtsG ImperatoreL TavazziF PellegriniCm SudS ImbaroG FabbriG LevantesiF TurazzaS GentileS PanicoP MocarelliP BrambillaS SignoriniF CappelliniC ParmaA NicolucciD D'alonzoB Di NardoS FerrariM FranciosiR PecceM ValentiniCm SudS ImbaroM CeseriF BianchiniE BaldiniA AtzoriM BoemiF D'angeloR GiansantiL RicciA RanchelliP Di BerardinoE CannarsaF GiorginoM ManiconeL TarantinoR TrevisanC ScarannaG ForlaniL MontesiA AielloA BarreaS SquatritoT SinagraS LonghitanoG SestiA GnassoC CaralloC ScicchitanoC SantiniG CalbucciR RipaniL CorsiS CorsiCb GiordaF RomeoV AsprinoG DonnarummaB TizioG ClementeF TomasiN DozioE MannucciC LamannaM CignarelliOl MacchiaS FarielloR CorderaC MazzucchelliM PupilloA ZugaroA BoscoA De LucaR IannarelliA GiulianiL PolidoroA SperandioF SciarrettaB RaffaellaC VendittiG Di CianniC GorettiMa DolciL BruselliM MoriF BaccettiG GregoriA VeneziaD CucinottaB PintaudiF RagoneseP PataPm PiattiP LuccottiE OrsiM BonomoL MenicattiAa RivelleseAa TurcoO CianoP VallefuocoG CoriglianoC PentangeloE PetraroliP AulettaO CarbonaraG CapobiancoG CaiazzoB AngiulliG De SimoneC MicheleV MastrilliG NunziataG RomanoI GaetaT SorrentinoC IovineG DonnarummaF NappiG PaolissoMr RizzoA AvogaroM VedovatoA LapollaG SartoreS BurlinaNc ChilelliA GalluzzoyC GiordanoV TorregrossaL ArsenioE Dall'aglioF CioniM BabiniG MoncastroppaG PerrielloA TimiA ConsoliF GinestraD ZavaroniF CalzoniS Del PratoR MiccoliC BianchiS PolitiR AnichiniA TedeschiG CitroA ZampinoS RosaM NataleCl GiocoliA VeneziaE CarusoL TramontanoA ImbroiniseCd PernaM CalabreseA ZogheriA LubertoG BallardiniAc BabiniC ZannoniG PuglieseL SalviG MazzitelliA ZappaterrenoS FrontoniA VentriciniD LauroA GalliMe RinaldiS LeottaL FontanaS GorettiP PozzilliF LeonettiS MoranoS FilettiSd CosmoS BacciAp PalenaP CalatolaG CapuanoU AmeliaFrancesco DottaE GuarinoE CeccarelliC LalliM ScarponiE ForteS PotenzianiPc PerinS MarenaC ZuccoM PerottoA BossiM FilopantiF GrimaldiL TonuttiA CavarapeE BonoraM CigoliniI PichiriC BranganiE TomasettoC CapraM. Cigolinisubject
Blood GlucoseMaleBIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICAEndocrinology Diabetes and Metabolismpioglitazone sulfonylurea type 2 diabetes metformin cardiovascular eventsMedicine (miscellaneous)Type 2 diabetesSettore MED/13 - EndocrinologiaBody Mass Indexlaw.inventionRandomized controlled trialRisk FactorslawSurveys and QuestionnairesCardiovascular DiseasepioglitazonepiogllitazoneStrokeDiabetes Therapy PioglitazoneNutrition and DieteticsDiabetesThiazolidinedionecardiovascular events; pioglitazone; Type 2 Diabetes Mellitus; sulphonylureasType 2 diabetesMiddle AgedMetforminSulfonylurea CompoundTreatment OutcomeTolerabilitysulphonylureasCardiovascular DiseasesDrug Therapy CombinationFemaletype 2 diabetesCardiology and Cardiovascular MedicineHumanmedicine.drugmedicine.medical_specialtyEndpoint Determinationsulfonylureacardiovascualr eventSudden deathFollow-Up Studiecardiovascular eventsInternal medicineDiabetes mellitusmedicineHumansHypoglycemic Agentssulfonylureasinterventio trialtype 2 diabetes; cardiovascular events; pioglitazone; sulfonylureas; randomized controlled trialAgedHypoglycemic AgentQuestionnairebusiness.industryRisk Factormedicine.diseaseSurgeryType 2 Diabetes MellitusSulfonylurea CompoundsDiabetes Mellitus Type 2randomized controlled trialQuality of LifeThiazolidinedionesTherapybusinessmetforminPioglitazoneFollow-Up Studiesdescription
Abstract Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-11-01 |