IONA Impact Of Nicorandil in Angina A Presentation

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

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

IONA - current medical treatment of angina Anti anginal : – – nitrates beta blockers Ca++ channel blockers nicorandil Preliminary results AHA 2001 Disease modifying : – anti-platelet – statin – ACE inhibitors

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

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

IONA Secondary End Point : Coronary Heart Disease Death + Non Fatal Myocardial Infarction Preliminary results AHA 2001

IONA Exploratory Analyses : – All cause mortality – All cardiovascular events

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 Preliminary results AHA 2001

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) Preliminary results AHA 2001

IONA Recruitment and follow up – 5126 patients recruited • 2561 (P), 2565 (N) – Average follow up of 1. 6 years • (1 - 3 years) Preliminary results AHA 2001

IONA Baseline characteristics Male (%) 76 Smoker (%) 16 Previous MI (%) PTCA/CABG (%) Diabetes (%) 8 Hypertension (%) PVD (%) 12 Stroke/TIA (%) 7 Preliminary results AHA 2001 66 34 46 Age (years) SBP (mm. Hg) DBP (mm. Hg) CCSF (%) I II IV 67 138 79 27 62 11 1

IONA Baseline therapy (%) Antiplatelet -blocker Ca-antagonist Nitrate Statin ACE inhibitor Insulin Hypoglycaemic Preliminary results AHA 2001 88 56 55 86 57 29 3. 4 2. 1

(RRR = 17%, P = 0. 014) Nicorandil Placebo Preliminary results AHA 2001

Nicorandil Placebo Preliminary results AHA 2001 (RRR = 21%, P=0. 068)

(RRR = 13%, P = 0. 27) Nicorandil Placebo Preliminary results AHA 2001

(RRR = 15%, P = 0. 025) Nicorandil Placebo Preliminary results AHA 2001

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 Preliminary results AHA 2001

IONA - future medical treatment of angina Anti anginal : – – nitrates beta blockers Ca++ channel blockers nicorandil Preliminary results AHA 2001 Disease modifying : – – anti-platelet statin ACE inhibitors nicorandil