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Diabetes and Cardiovascular Risk La lezione dai grandi studi di intervento.

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Presentazione sul tema: "Diabetes and Cardiovascular Risk La lezione dai grandi studi di intervento."— Transcript della presentazione:

1 Diabetes and Cardiovascular Risk La lezione dai grandi studi di intervento

2 Rischio di eventi cardiovascolari a 8 anni nel diabete (Framingham Study)

3 CHD Mortality in T2DM and in Non- diabetics with and without Prior AMI Haffner, N Engl J Med 1998

4 Cardiovascular and total mortality in DM and prior MI Vaccaro, Arch Intern Med 2004 DM and MI were similarly strong predictors of total mortality. Higher mortality from non-CVD causes was observed in those with DM only. Prior MI was more strongly predictive of CHD mortality than DM at any age and level of CVD risk factors. The difference in CHD mortality between the 2 groups was most evident in the first 10 years of follow-up.

5 Rischio stimato di malattia cardiovascolare nel DM1 Soedemah-Muthu, General Practice Research Database, Diabetes Care 2006 Casi indice: 7479 DM1 5x Controlli Liberi da malattia CV al momento dello studio

6 Controllo glicemico ed eventi cardiovascolari (UKPDS-33) UKPDS Group, Lancet 1998

7 Controllo glicemico ed eventi cardiovascolari (UKPDS-34) UKPDS Group, Lancet 1998

8 Glucose control and micro- /macrovascular complications (UKPDS 35) Stratton, BMJ 2000

9 Impatto del diabete su CHD instabile Malmberg, Circulation 2000

10 Compenso glicemico e rischio macrovascolare DCCT/EDIC, NEJM 2005 P = 0.02

11 Compenso glicemico e rischio macrovascolare DCCT/EDIC, NEJM 2003

12 Systolic blood pressure and micro- /macrovascular complications (UKPDS 36) Adler, BMJ 2000

13 Blood pressure control and micro- /macrovascular complications (UKPDS 38) UKPDS Study Group, BMJ 1998

14 Metanalysis of BP-lowering regimens on total mortality in pts with and without DM BP Lowering Treatment Trialists' Collaboration, Arch Intern Med 2005

15 Metanalysis of BP-lowering regimens on CHD risk in pts with and without DM BP Lowering Treatment Trialists' Collaboration, Arch Intern Med 2005

16 Metanalysis of BP-lowering regimens on CV deaths in patients with and without DM BP Lowering Treatment Trialists' Collaboration, Arch Intern Med 2005

17 Metanalysis on BP-lowering regimens on major CV events in pts with and without DM BP Lowering Treatment Trialists' Collaboration, Arch Intern Med 2005

18 Metanalysis of BP-lowering regimens on stroke risk in pts with and without DM BP Lowering Treatment Trialists' Collaboration, Arch Intern Med 2005

19 Fattori di rischio coronarico nel diabete (UKPDS-23) Turner, BMJ 1998

20 Fattori di rischio coronarico nel diabete (UKPDS-23) Turner, BMJ 1998

21 Long-term CHD primary prevention The 4S extension Strandberg, Lancet 2004

22 Lipid-lowering action of different statins and NCEP-ATPIII goal From Tuomilehto, Diab Res Clin Pract 2005

23 Cheung, Br J Clin Pharmacol 2003 Meta-analisys of statin use in CHD prevention

24 Statina-prevenzione 2 aria Placebo-prevenzione 2 aria Statina-prevenzione 1 aria Placebo-prevenzione 1 aria Adattato da Ballantyne CM. Am J Cardiol 1998; 82 (9A): 3Q-12Q; OKeefe JH et al. J Am Coll Cardiol 2004; 43 (11): mg/dl WOSCOPS-P WOSCOPS-S AFCAPS-P AFCAPS-S LIPID-S CARE-S 4S-S CARE-P LIPID-P 4S-P 30 HPS-P HPS-S LIPS-P ASCOT-S ASCOT-P LIPS-S PROVE-IT A PROVE-IT P TNT 80 TNT 10 AtoZ 20 AtoZ 80 Eventi coronarici (%) C-LDL LDL e rischio coronarico negli studi clinici di riduzione delliperlipidemia

25 Adattato da Grundy SM et al. Circulation 2004;110 (2): Rischio elevato di CHD o equivalenti di rischio coronarico (rischio a 10 anni > 20%) Livelli di C-LDL Rischio moderatamente alto 2 fattori di rischio (rischio a 10 anni 10-20%) Rischio moderato 2 fattori di rischio (rischio a 10 anni < 10%) Basso rischio < 2 fattori di rischio Target 130 mg/dL Target 130 mg/dL Target 160 mg/dL Target 100 mg/dL or optional 70 mg/dL or optional 100 mg/dL The lower the better ATP III aggiorna gli obiettivi di C-LDL nel 2004

26 Meta-analysis on primary CHD prevention by statins (8 trials) Total mortality Serious AE CV events CHD events (females) CV events (>65 yrs) Abramson & Wright, Lancet 2007

27 Yusuf, Lancet 2002 CHD secondary prevention In smokers, an additional 50% reduction is expected, lowering the RR by 80% (to 20% of basal values)

28 Keech, Diabetes Care 2003 Diabetes & CV Risk Pravastatin secondary prevention (LIPID study) 1077 with DM and 940 IGT (out of 9014 overall population) Pravastatin, 40 mg Age, years T-Xol, mmol/L

29 Keech, Diabetes Care 2003 Diabetes & CV Risk Meta-analisys of secondary prevention (LIPID study)

30 Diabetes & CV Risk Effect of aggressive treatment (TNT study) Pts with DM and overt CHD LDL-Xol <130 mg/dL Follow-up, 4.9 yrs (out of total pts with CHD) Significant differences in most individual outcomes No differences in total mortality Sheperd, Diabetes Care 2006

31 Diabetes & CV Risk Effect of aggressive treatment (TNT study) An average 3-5% ARR is observed across different groups, independent of metabolic control (HbA1c), age, entry LDL-Xol, duration of diabetes.

32 CHD primary prevention in DM The CARDS trial Colhoun, Lancet Pts, with no previous history of CHD; LDL-Xol < 4.14 mMol, TG < 6.78 mMol Tx: Atorvastatin 10 mg vs. Pl The study was prematurely halted

33 CHD primary prevention in DM The CARDS trial Colhoun, Lancet 2004

34 CHD primary prevention in DM Garg, Lancet 2004

35 Intervento multifattoriale e rischio CV nel DM2 (STENO-2) RCT trattamento convenzionale vs. trattamento intensivo 160 Pazienti con DM2 Età, 55 anni; Follow-up, 7.8 anni Trattamento intensivo: Progressiva educazione per modificare lo stile di vita Stretto controllo della glicemia, ipertensione, dislipemia, microalbuminuria con terapia farmacologica intensiva (+ aspirina). Outcome primario: Morte per causa CV, infarto non fatale, stroke non fatale, necessità di rivascolarizzazione, amputazione. Gaede, NEJM 2003

36 STENO-2: percentuale di pazienti a target Gaede, NEJM 2003

37 STENO-2: risultati sulloutcome primario composito Gaede, NEJM 2003 Outcome primario: Morte per causa CV infarto non fatale stroke non fatale necessità di chirurgia vascolare amputazione

38 STENO-2: risultati sullo sviluppo di complicanze Gaede, NEJM 2003

39 Dormandy, Lancet 2005 Pioglitazone and macrovascular events (PROACTIVE study) 5238 Pts with T2DM and macrovascular disease PIO mg/d Average F-up, 34.5 mo Primary outcome: composite end- point - not different

40 Dormandy, Lancet 2005 Pioglitazone and macrovascular events (PROACTIVE study) Significant differences in a secondary end-point (composite) Concern for fluid retention

41 Cumulative Incidence Time since Randomization, y Development of MS by intervention group in the DPP Orchard, Ann Intern Med 2005

42 DPS - risultati a lungo termine Lindstrom, Lancet 2006 Durante il follow-up si allarga ulteriormente la differenza tra gruppo di controllo e di intervento Lo spostamento sullasse delle ascisse supera i 4 anni

43 DPS - risultati a lungo termine Lindstrom, Lancet 2006 Durante il follow-up si allarga ulteriormente la differenza tra gruppo di controllo e di intervento

44 Lifestyle vs. farmaci - metaanalisi Gillies, BMJ 2007

45 Lifestyle treatment of Htx The PREMIER experience PREMIER Collaborative Research Group, JAMA 2003 RCT on the effects on BP of behavioral approach ± DASH (dietary approach to stop Htx) 810 pts with above optimal BP Outcome Htx status at 6 mo Behavior intervention 4 individual + 14 group sessions Format recording of food diaries, physical activity, calorie and Na intake +DASH: fruit, vegetables, fat snd dairy product intake

46 Lifestyle treatment of Htx The PREMIER experience PREMIER Collaborative Research Group, JAMA 2003

47 Incident DM in RCT of hypertension A network meta-analysis 48 groups in 22 RCT on pharmacologic treatment of Htx pts without DM at entry Main outcome: proportion of Pts who develops DM Elliott & Meyer, Lancet 2007

48 Incident DM in RCT of hypertension A network meta-analysis Elliott & Meyer, Lancet 2007


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