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K Fox, W Remme, C Daly, M Bertrand, R Ferrari, M Simoons On behalf of the EUROPA investigators.

The diabetic sub study of. K Fox, W Remme, C Daly, M Bertrand, R Ferrari, M Simoons On behalf of the EUROPA investigators. Background. ACE inhibitor therapy of proven benefit in secondary prevention in myocardial infarction and heart failure

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K Fox, W Remme, C Daly, M Bertrand, R Ferrari, M Simoons On behalf of the EUROPA investigators.

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  1. The diabetic sub study of K Fox, W Remme, C Daly, M Bertrand, R Ferrari, M Simoons On behalf of the EUROPA investigators.

  2. Background • ACE inhibitor therapy of proven benefit in secondary prevention in myocardial infarction and heart failure • EUROPA concluded that perindopril was also beneficial in patients with CAD, without heart failure and with broad range of risk • Within the coronary disease population, diabetics are a subpopulation at high risk

  3. Aim of the study To investigate the effect of the ACE inhibitorperindopril 8 mg once daily added to standard therapy on cardiovascular events in diabetic patients with documented coronary disease

  4. Study endpoints Primary endpoint • CV mortality + non fatal MI + cardiac arrest Secondary endpoints • Fatal and non-fatal MI • Non-fatal MI • Stroke • Hospitalisation for heart failure • Development of renal failure

  5. Patient population • Known diabetes at randomisation: n=1502 • Male or female > 18 years of age • Documented coronary disease • Not scheduled for revascularisation • No clinical signs of heart failure

  6. Age (yrs) 60 ± 9 62 ± 9 62 ± 9 Male (%) 85 83 81 Weight (kg) 81 ± 12 83 ± 13 82 ± 13 SBP (mmHg) 137 ± 15 140 ± 15 140 ± 16 DBP (mmHg) 82 ± 8 81 ± 8 82 ± 8 Baseline characteristics EUROPA PERSUADE n=1502 Perindopril(mean ± SD) Placebo(mean ± SD) (mean ± SD)

  7. MI 65 65 68 CABG 32 30 33 PCI 29 27 26 Stroke / TIA 3 6 5 PVD 7 14 12 Medical history & risks EUROPA PERSUADE n=1502 Perindopril(%) Placebo(%) (%) Hypertension 27 38 41 Hyperlipidemia 63 61 61

  8. 14.1 PERSUADE EUROPA 11.1 8.9 8.9 7.1 6.5 6.0 3.8 2.7 2.5 1.6 1.3 1.0 0.6 PrimaryEndpoint TotalMortality CVMortality MI Stroke HeartFailure Doubl.Creatinine Clinical outcome (%) 16 14 12 10 8 6 4 2 0

  9. RRR with perindopril Perindopril better Placebo better Primary Endpoint Total Mortality CV mortality All MI Non Q MI Heart Failure Stroke (%) RRR 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8

  10. 20 PERSUADE RRR 19%p=0.131 placebo 16 perindopril 12 placebo PERSUADE 8 perindopril 4 0 Primary endpoint % CV death, MI and cardiac arrest EUROPA 0 1 2 3 4 5 Years from randomisation

  11. PERSUADE RRR 23%p=0.143 placebo placebo perindopril PERSUADE perindopril 0 1 2 3 4 5 Fatal and non fatal MI (%) 14 10 6 4 EUROPA 0 Years from randomisation

  12. placebo PERSUADE RRR 46%p=0.06 perindopril placebo PERSUADE perindopril Heart Failure (%) 4 2 EUROPA 0 0 1 2 3 4 5 Years from randomisation

  13. Summary of results • In PERSUADE, the relative risk reduction withperindopril on 1° and 2° endpoints was similar tothat in the main EUROPA population • Primary endpoint RRR 19% • Fatal and nonfatal MI RRR 23% • Heart Failure RRR 46%

  14. Conclusion Perindopril 8 mg once daily reducescardiovascular eventsin patients with coronary diseaseand diabetes NNT to prevent one cardiovascular deathor nonfatal myocardial infarction is just27 patients over 4 years

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