scuola di specializzazione in malae dell’apparato cardiovascolare … · 2016-01-04 · scuola di...
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ScuoladiSpecializzazioneinMala/edell’ApparatoCardiovascolareDire8oreProf.MassimoVolpeFacoltàdiMedicinaePsicologia,UniversitàdiRomaSapienzaAnnoAccademico2014-2015Dr.ssaA8allaElHalabiehNadia
Proge8oFormazioneAvanzatainCardiologianelWeb2015ScuoladiSpecializzazioneinMala/edell’ApparatoCardiovascolare
Dire8ore:Prof.MassimoVolpe
E-mail:[email protected]
Coordinatore:Dr.GiulianoTocciE-mail:[email protected]
EffectofSitaglip/nonCardiovascularoutcomesintype2Diabetes
(TECOS)
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
• Sitaglip/nisanoralan^hyperglycemicagent:DPP-4inhibitorthatincreasestheac^velevelsofincre^ns.
• Preclinicalandclinicalstudieshaveinves^gatedtheCVeffectsofDPP-4inhibitorsorGLP-1analoguesinHFexperimentalmodelsorHFpa^entsandshownimprovementsincardiacfunc^onandprotec^onagainstthedevelopmentofadverseremodelling1-3.
• Observa^onfrom2recentlargetrialssuggestanincreasedriskforhospitaliza^onforHFwithDPP-4inhibitors(SAVOR-TIMIandEXAMINE).
Background
1.KhanMA,etal.HeartFailRev2013;18:141–482.TakahashiA,etal.AmJPhysiolHeartCircPhysiol2013;304:H1361–69
3.ShigetaT,etal.Circula^on2012;126:1838–51
SAVOR-TIMI53Results
SciricaBM,etalNEJM2013;369:1317-26
N=16492Pa^entswithDMII,history
ofestablishedCVDormul^pleriskfactorsforCVD,withHbA1c6,5-12%.
EXAMINEResultsinapost-hocanalysis
ZannadF,etal.Lancet2015;385:2067-76
N=5380Pa^entswithDMIIanda
recentSCA.
Objec/ve
• Todeterminewhethertheaddi^onofSitaglip^ntousualcareisassociatedwithlong-termcardiovascularsafetyinpa^entwithtype2diabetesandestablishedcardiovasculardisease.
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
Studypopula/on
Inclusioncriteria:• type2diabetes• establishedcardiovasculardisease
(historyofmajorcoronaryarterydisease,ischemiccerebrovasculardiseaseoratherosclero^cperipheralarterialdisease)
• >50years• Glycatedhaemoglobinlevelof6,5to8%• Treatmentwithstabledosesofoneor
twooralan^diabe^cagentsorinsulin
Exclusioncriteria:• GFR<30mlperminuteper1,73m2• treatmentwithDPP-4inhibitor,GLP-1
receptoragonistorthiazolidinedioneduringthelast3months
• Historyoftwoormoreepisodesofseverehypoglycemia
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
Methods
Sitaglip^n100mgdaily(or50mgdailyiftheGFR30-50
ml/minper1,73m2)
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
Primaryoutcome• ItwasdefinedasthefirstconfirmedeventofCVdeath,nonfatalMI,nonfatalstrokeorhospitaliza^onforunstableangina.
Secondaryoutcome• Effectofhospitaliza^onforhearthfailure• Changesintheglycatedhaemoglobinlevel• ChangesintheGFR• Ini^a^onofaddi^onalan^hyperglycemicagentsorlong-terminsulintherapy• Frequencyofseverehypoglicemia
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
WhatistheimpactofSitaglip/nonHFhospitaliza/onintheoverallTECOSpopula/onandinkeyrelevantsubgroups?
Baselinecharacteris/csaccordingtoHFhospitaliza/on(1)
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
Baselinecharacteris/csaccordingtoHFhospitaliza/on(2)
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
Timetofirsthospitaliza/onforHF(overallpopula/on)
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
HF-relatedoutcomes:Sitaglip/nversusPlacebo
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
Conclusions• Sitaglip^ncanbesafelyusedintype2DMpa^ents
withoutconcernforworseningHF.
GreenJB,etal.fortheTECOSTrial.NEnglJMed2015Jul16;373(3):232-42
FinalConsidera/ons
Poten^alreasonsforthedifferentfindingsversusSAVOR-TIMI53andEXAMINE:• Differencesinpa^entsenrolled• Differencesinbackgroundcareprovided• Varia^oninacquisi^on/defini^onofHFamongtrials• IntrinsicpharmacologicdifferencesamongtheDDP-4
inhibitors
ScuoladiSpecializzazioneinMala/edell’ApparatoCardiovascolareDire8oreProf.MassimoVolpeFacoltàdiMedicinaePsicologia,UniversitàdiRomaSapienzaAnnoAccademico2014-2015Dr.ssaA8allaElHalabiehNadia
Proge8oFormazioneAvanzatainCardiologianelWeb2015ScuoladiSpecializzazioneinMala/edell’ApparatoCardiovascolare
Dire8ore:Prof.MassimoVolpe
E-mail:[email protected]
Coordinatore:Dr.GiulianoTocciE-mail:[email protected]
GrazieperlaVostraA8enzione!