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Diabetes and Cardiovascular Risk

Diabetes and Cardiovascular Risk. La lezione dai grandi studi di intervento. Rischio di eventi cardiovascolari a 8 anni nel diabete. (Framingham Study). CHD Mortality in T2DM and in Non-diabetics with and without Prior AMI. Haffner, N Engl J Med 1998.

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Diabetes and Cardiovascular Risk

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

  2. Rischio di eventi cardiovascolaria 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 • 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. Vaccaro, Arch Intern Med 2004

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

  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 P = 0.02 P = 0.02 DCCT/EDIC, NEJM 2005

  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 preventionThe 4S extension Strandberg, Lancet 2004

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

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

  24. 30 4S-P 25 20 LIPID-P 4S-S Eventi coronarici(%) 15 HPS-P CARE-P CARE-S LIPS-P LIPID-S 10 HPS-S AtoZ 20 WOSCOPS-P TNT 10 PROVE-IT A PROVE-IT P WOSCOPS-S LIPS-S 5 ASCOT-P TNT 80 AtoZ 80 AFCAPS-S ASCOT-S AFCAPS-P 0 50 70 110 130 150 170 190 210 90 C-LDL LDL e rischio coronarico negli studi clinicidi riduzione dell‘iperlipidemia Statina-prevenzione 1aria Placebo-prevenzione 1aria Statina-prevenzione 2aria Placebo-prevenzione 2aria mg/dl Adattato da Ballantyne CM. Am J Cardiol 1998; 82 (9A): 3Q-12Q; O’Keefe JH et al. J Am Coll Cardiol 2004; 43 (11): 2142-2146.

  25. Target 160 mg/dL 190 Target 130mg/dL Target 130mg/dL 160 Target 100mg/dL Livelli di C-LDL 130 or optional 100mg/dL 100 or optional 70mg/dL 70 Rischio elevato di CHD o equivalenti di rischio coronarico (rischio a 10 anni > 20%) 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 The lower the betterATP III aggiorna gli obiettivi di C-LDL nel 2004 Adattato da Grundy SM et al. Circulation 2004;110 (2):227-239.

  26. Meta-analysis on primary CHD prevention by statins (8 trials) 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 Total mortality Serious AE CV events CHD events (females) CV events (>65 yrs) Abramson & Wright, Lancet 2007

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

  28. Diabetes & CV RiskPravastatin secondary prevention (LIPID study) • 1077 with DM and 940 IGT (out of 9014 overall population) • Pravastatin, 40 mg • Age, 31-75 years • T-Xol, 4.0 - 7.0 mmol/L Keech, Diabetes Care 2003

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

  30. Diabetes & CV RiskEffect of aggressive treatment (TNT study) • 1.501 Pts with DM and overt CHD • LDL-Xol <130 mg/dL • Follow-up, 4.9 yrs • (out of 10.001 total pts with CHD) • Significant differences in most individual outcomes • No differences in total mortality Sheperd, Diabetes Care 2006

  31. Diabetes & CV RiskEffect 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. Sheperd, Diabetes Care 2006

  32. CHD primary prevention in DMThe CARDS trial 2838 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 Colhoun, Lancet 2004

  33. CHD primary prevention in DMThe 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 sull’outcome primario composito • Outcome primario: • Morte per causa CV • infarto non fatale • stroke non fatale • necessità di chirurgia vascolare • amputazione Gaede, NEJM 2003

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

  39. Pioglitazone and macrovascular events (PROACTIVE study) 5238 Pts with T2DM and macrovascular disease PIO 15-45 mg/d Average F-up, 34.5 mo Primary outcome: composite end-point - not different Dormandy, Lancet 2005

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

  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 Durante il follow-up si allarga ulteriormente la differenza tra gruppo di controllo e di intervento Lo spostamento sull’asse delle ascisse supera i 4 anni Lindstrom, Lancet 2006

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

  44. Lifestyle vs. farmaci - metaanalisi Gillies, BMJ 2007

  45. Lifestyle treatment of HtxThe PREMIER experience • 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 PREMIER Collaborative Research Group, JAMA 2003

  46. Lifestyle treatment of HtxThe PREMIER experience PREMIER Collaborative Research Group, JAMA 2003

  47. Incident DM in RCT of hypertensionA network meta-analysis 48 groups in 22 RCT on pharmacologic treatment of Htx 143.153 pts without DM at entry Main outcome: proportion of Pts who develops DM Elliott & Meyer, Lancet 2007

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

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