IONA

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
IONA- current medical treatment of angina

• Anti anginal
• nitrates
• beta blockers
• Ca channel blockers
• nicorandil

• Disease modifying
• anti-platelet
• statin
• ACE inhibitors

4
IONA

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

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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

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IONA

• Secondary End Point
• Coronary Heart Disease Death
• Non Fatal Myocardial Infarction

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IONA

• Exploratory Analyses
• All cause mortality
• All cardiovascular events

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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

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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)

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IONA

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

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IONA Baseline
characteristics

• 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

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IONA Baseline therapy ()

• Antiplatelet 88
• ?-blocker 56
• Ca-antagonist 55
• Nitrate 86
• Statin 57
• ACE inhibitor 29
• Insulin 3.4
• Hypoglycaemic 2.1

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(RRR 17, P 0.014)
Nicorandil
Placebo
14
Nicorandil
(RRR 21, P0.068)
Placebo
15
(RRR 13, P 0.27)
Nicorandil
Placebo
16
(RRR 15, P 0.025)
Nicorandil
Placebo
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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

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IONA- future medical treatment of angina

• Anti anginal
• nitrates
• beta blockers
• Ca channel blockers
• nicorandil

• Disease modifying
• anti-platelet
• statin
• ACE inhibitors
• nicorandil