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IONA

IONA. I mpact O f N icorandil in A ngina A Presentation given by Henry J Dargie Western Infirmary and University of Glasgow at the AHA Conference 14th Nov 2001. IONA. Background : Angina is common - affects over 10% of men and women over 60 Angina is disabling

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  1. IONA Impact Of Nicorandil in Angina A Presentation given by Henry J Dargie Western Infirmary and University of Glasgow at the AHA Conference 14th Nov 2001

  2. IONA • Background : • Angina is common - affects over 10% of men and women over 60 • Angina is disabling - quality of life can be poor • Angina affects outcome variably - 3% to 20% annual rate of cardiac events

  3. Anti anginal : nitrates beta blockers Ca++ channel blockers nicorandil Disease modifying : anti-platelet statin ACE inhibitors IONA- current medical treatment of angina

  4. IONA • Objective : To investigate the impact of nicorandil on outcome in patients with angina of effort - when added to existing treatments

  5. IONA • Primary Hypothesis : Treatment with nicorandil will reduce the incidence of the primary endpoint by 25% • Primary End Point : Coronary Heart Disease Death + Non fatal Myocardial Infarction + Unplanned Hospitalisation for Cardiac Chest Pain

  6. IONA • Secondary End Point : • Coronary Heart Disease Death • + • Non Fatal Myocardial Infarction

  7. IONA • Exploratory Analyses : • All cause mortality • All cardiovascular events

  8. IONA • Design and Methodology : • Double blind, randomised controlled trial of nicorandil versus placebo • 10 mg bd increasing to 20 mg bd after 2 weeks • Higher risk patients on existing medication • not being actively considered for revascularisation • Conducted exclusively in the UK • recruitment from hospital and primary care • Analysis was by intention to treat

  9. IONA • Inclusion criteria • Men or women • Stable angina with high risk features • Need for regular oral anti anginal medication (long acting nitrate, beta blocker or calcium channel blocker)

  10. IONA • Recruitment and follow up • 5126 patients recruited • 2561 (P), 2565 (N) • Average follow up of 1.6 years • (1- 3 years)

  11. Male (%) 76 Smoker (%) 16 Previous MI (%) 66 PTCA/CABG (%) 34 Diabetes (%) 8 Hypertension (%) 46 PVD (%) 12 Stroke/TIA (%) 7 Age (years) 67 SBP (mmHg) 138 DBP (mmHg) 79 CCSF (%) I 27 II 62 III 11 IV 1 IONA Baseline characteristics

  12. Antiplatelet 88 -blocker 56 Ca-antagonist 55 Nitrate 86 Statin 57 ACE inhibitor 29 Insulin 3.4 Hypoglycaemic 2.1 IONA Baseline therapy (%)

  13. (RRR = 17%, P = 0.014) Nicorandil Placebo

  14. Nicorandil (RRR = 21%, P=0.068) Placebo

  15. (RRR = 13%, P = 0.27) Nicorandil Placebo

  16. (RRR = 15%, P = 0.025) Nicorandil Placebo

  17. IONA • Summary • In patients with chronic stable angina: • Nicorandil significantly reduced the incidence of major coronary events and all cardiovascular events • IONA is the first large scale clinical trial to report on the effects of a specific anti - anginal medication on clinical outcome

  18. Anti anginal : nitrates beta blockers Ca++ channel blockers nicorandil Disease modifying : anti-platelet statin ACE inhibitors nicorandil IONA-future medical treatment of angina

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