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30. 20. 10. 0. CORONA - Primary Endpoint. The combined endpoint of cardiovascular death or non-fatal MI or non-fatal stroke (time to first event). Placebo. Rosuvastatin 10 mg. Percent of patients with primary endpoint. Hazard ratio = 0.92 (95% CI 0.83 to 1.02) p =0.12. 0. 6. 12.
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30 20 10 0 CORONA - Primary Endpoint The combined endpoint of cardiovascular death or non-fatal MI or non-fatal stroke (time to first event) Placebo Rosuvastatin 10 mg Percent of patients with primary endpoint Hazard ratio = 0.92 (95% CI 0.83 to 1.02) p=0.12 0 6 12 18 24 30 36 Months of follow-up No. at risk Placebo 2497 2315 2156 2003 1851 1431 811 Rosuvastatin 2514 2345 2207 2068 1932 1484 855 Kjekshus et al. N Engl J Med 2007;357(22):2248-61.
CORONA Atherosclerotic Events 15 Post- hoc analysis of the number fatal/non-fatal MI or stroke in the primary endpoint Placebo 12 Rosuvastatin 10 mg 9 Percent of patients with event Hazard ratio = 0.84 (95% CI 0.70 to 1.00) p = 0.05 6 3 0 0 6 12 18 24 30 36 Months of follow-up No. at risk Placebo 2497 2315 2156 2003 1851 1431 811 Rosuvastatin 2514 2345 2207 2068 1932 1484 855 Kjekshus et al. N Engl J Med 2007;357(22):2248-61.
CORONA – Secondary Endpoints Total number of hospitalizations Placebo (n=2,497) 4,074 Rosuvastatin 10 mg (n=2,514) 4,000 3,694 3,000 2,564 Number of hospitalizations 2,193 2,000 1,510 1,501 1,299 1,109 1,000 0 All cause CV cause Heart failure Non-CV cause p=0.007 p<0.001 p=0.01 Kjekshus et al. N Engl J Med 2007;357(22):2248-61.
CORONA – Side Effects and Adverse Events Tolerability and safety data Placebo Rosuvastatin [n=2497] [n=2514] no. of pts no. of pts Discontinuation of study drug1546 490 Adverse event2 302 241 Patient unwilling to continue 162 187 Other reason 82 62 1Hazard ratio 0.88; (95% CI 0.78 to 0.99; p=0.03)2Hazard ratio 0.78; (95% CI 0.66 to 0.92; p=0.004) Kjekshus et al. N Engl J Med 2007;357(22):2248-61.