Dr.ssa A8alla El Halabieh Nadia

Transcript

1 Scuola di Specializzazione in Mala/e dell Apparato Cardiovascolare Dire8ore Prof. Massimo Volpe Facoltà di Medicina e Psicologia, Università di Roma Sapienza Anno Accademico Dr.ssa A8alla El Halabieh Nadia Proge8o Formazione Avanzata in Cardiologia nel Web 2015 Scuola di Specializzazione in Mala/e dell Apparato Cardiovascolare Dire8ore: Prof. Massimo Volpe massimo.volpe@uniroma1.it Coordinatore: Dr. Giuliano Tocci giuliano.tocci@uniroma1.it

2 Effect of Sitaglip/n on Cardiovascular outcomes in type 2 Diabetes (TECOS) Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

3 Sitaglip/n is an oral an^hyperglycemic agent: DPP-4 inhibitor that increases the ac^ve levels of incre^ns.

4 Background Preclinical and clinical studies have inves^gated the CV effects of DPP-4 inhibitors or GLP-1 analogues in HF experimental models or HF pa^ents and shown improvements in cardiac func^on and protec^on against the development of adverse remodelling 1-3. Observa^on from 2 recent large trials suggest an increased risk for hospitaliza^on for HF with DPP-4 inhibitors (SAVOR-TIMI and EXAMINE). 1. Khan MA, et al. Heart Fail Rev 2013; 18: Takahashi A, et al. Am J Physiol Heart Circ Physiol 2013; 304: H Shigeta T, et al. Circula^on 2012; 126:

5 SAVOR-TIMI 53 Results N=16492 Pa^ents with DM II, history of established CVD or mul^ple risk factors for CVD, with HbA1c 6,5-12%. Scirica BM, et al NEJM 2013; 369:

6 N=5380 Pa^ents with DM II and a recent SCA. EXAMINE Results in a post-hoc analysis Zannad F, et al. Lancet 2015;385:

7 Objec/ve To determine whether the addi^on of Sitaglip^n to usual care is associated with longterm cardiovascular safety in pa^ent with type 2 diabetes and established cardiovascular disease. Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

8 Study popula/on Inclusion criteria: type 2 diabetes established cardiovascular disease (history of major coronary artery disease, ischemic cerebrovascular disease or atherosclero^c peripheral arterial disease) > 50 years Glycated haemoglobin level of 6,5 to 8% Treatment with stable doses of one or two oral an^diabe^c agents or insulin Exclusion criteria: GFR < 30 ml per minute per 1,73m2 treatment with DPP-4 inhibitor, GLP-1 receptor agonist or thiazolidinedione during the last 3 months History of two or more episodes of severe hypoglycemia Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

9 Methods Sitaglip^n 100 mg daily (or 50 mg daily if the GFR ml/min per 1,73 m2) Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

10 Primary outcome It was defined as the first confirmed event of CV death, non fatal MI, non fatal stroke or hospitaliza^on for unstable angina. Secondary outcome Effect of hospitaliza^on for hearth failure Changes in the glycated haemoglobin level Changes in the GFR Ini^a^on of addi^onal an^hyperglycemic agents or long-term insulin therapy Frequency of severe hypoglicemia Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

11 Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

12 Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

13 Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

14 What is the impact of Sitaglip/n on HF hospitaliza/on in the overall TECOS popula/on and in key relevant subgroups?

15 Baseline characteris/cs according to HF hospitaliza/on (1) Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

16 Baseline characteris/cs according to HF hospitaliza/on (2) Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

17 Time to first hospitaliza/on for HF (overall popula/on) Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

18 Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

19 HF-related outcomes: Sitaglip/n versus Placebo Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

20 Conclusions Sitaglip^n can be safely used in type 2 DM pa^ents without concern for worsening HF. Green JB, et al. for the TECOS Trial. N Engl J Med 2015 Jul 16;373(3):232-42

21 Final Considera/ons Poten^al reasons for the different findings versus SAVOR-TIMI 53 and EXAMINE: Differences in pa^ents enrolled Differences in background care provided Varia^on in acquisi^on/defini^on of HF among trials Intrinsic pharmacologic differences among the DDP-4 inhibitors

22 Scuola di Specializzazione in Mala/e dell Apparato Cardiovascolare Dire8ore Prof. Massimo Volpe Facoltà di Medicina e Psicologia, Università di Roma Sapienza Anno Accademico Dr.ssa A8alla El Halabieh Nadia Grazie per la Vostra A8enzione! Proge8o Formazione Avanzata in Cardiologia nel Web 2015 Scuola di Specializzazione in Mala/e dell Apparato Cardiovascolare Dire8ore: Prof. Massimo Volpe massimo.volpe@uniroma1.it Coordinatore: Dr. Giuliano Tocci giuliano.tocci@uniroma1.it