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CURE: Design Issues

CURE: Design Issues. 12, 562 patients enrolled in 28 countries Europe enrolled 5,000; Canada enrolled 2,000; the US enrolled 500 Male: 61% Unstable angina 75% EKG abnormal 93% Elevated troponin 25% Heparin 46% LMWH 50% Beta blocker 78% Lipid lowering 47%. S Yusuf, Am Coll Cardiol 2001.

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CURE: Design Issues

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  1. CURE: Design Issues • 12, 562 patients enrolled in 28 countries • Europe enrolled 5,000; Canada enrolled 2,000; the US enrolled 500 • Male: 61% • Unstable angina 75% • EKG abnormal 93% • Elevated troponin 25% • Heparin 46% • LMWH 50% • Beta blocker 78% • Lipid lowering 47% S Yusuf, Am Coll Cardiol 2001

  2. CURE: Design Issues 12,562 pts. Randomized to either ASA 75 to 325 mg PO qd ASA + Clopidogrel (300 mg load, 75 mg qd) 3 to 12 month follow-up Average 9 months S Yusuf, Am Coll Cardiol 2001

  3. CURE: Primary Endpoint Results Risk Ratio 0.80 p=0.00005 11.47% 9.28% There was a 20% reduction in the primary endpoint of the study CV Death / MI / Stroke (%) N = 6,259 N = 6,303 Aspirin + Clopidogrel Aspirin S Yusuf, Am Coll Cardiol 2001

  4. CURE: Subgroup Results P = NS P = NS P < 0.001 P = NS 5.4% 5.06% 6.68% 0.67% 1.4% 0.7% 5.19% 1.2% MI (%) Risk of Stroke (%) Non CV Death (%) CV Death (%) S Yusuf, Am Coll Cardiol 2001

  5. CURE: Other efficacy results Aspirin + clopidogrel (n=6259) Endpoint Aspirin (n=6303) Relative risk p value CV death, MI, stroke , refractory ischemia (2nd primary endpoint) 19.02% 16.68% 0.88 0.0004 Refractory ischemia 8.8% 0.93 9.4% N/A Refractory ischemia in hospital 2.08% 1.42% 0.69 Significant Refractory ischemia after discharge 7.66% 7.67% 1.00 N/A Severe ischemia 5.03% 0.76 0.001 3.83% S Yusuf, Am Coll Cardiol 2001

  6. CURE: Bleeding Results Aspirin + clopidogrel (n=6259) Relative risk p value Endpoint Aspirin (n=6303) Major bleeding 2.7% 3.6% 1.34 0.003 2.1% Life-threatening bleeding N/A 1.8% 1.15 15.3% 1.78 <0.001 Minor bleeding 8.6% Transfusions 2.2% 2.8% 1.28 0.03 S Yusuf, Am Coll Cardiol 2001

  7. CURE: High-risk/low-risk subgroup analysis: primary endpoint Aspirin (n=6303) Aspirin + clopidogrel (n=6259) Endpoint Risk ratio ST changes 14.3% 11.5% 0.79 No ST changes 8.7% 7.0% 0.80 Enzyme elevations 0.81 13.1% 10.7% 0.79 No enzyme elevations 10.9% 8.8% Previous revascularizations 8.4% 0.55 14.6% No previous revascularizations 10.8% 9.5% 0.87 Postrandimization revascularizations 11.4% 0.81 1.39% No postrandimization revascularizations 0.79 8.4% 10.1% S Yusuf, Am Coll Cardiol 2001

  8. CURE: Results in Context • Potential Magnitude of Benefit • 2 million hospitalizations each year for ACS in US alone • “50,000 to 100,000 deaths, MIs and strokes could be prevented each year in North America alone” (S. Yusuf, P.I.) • 250,000 to 500,000 major events prevented worldwide even if only 20% of eligible patients are treated • Potential Obstacles to Benefit • Cost of $2.00 to $3.00 per day per pill, not covered by Medicare outpatient costs (inpatient costs of the drug would be covered) S Yusuf, Am Coll Cardiol 2001

  9. CURE: Future Studies • There are 12 million patients with stable CAD in the US and it is unclear if these patients would benefit from the drug and this will require further study S Yusuf, Am Coll Cardiol 2001

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