Reducing the risk of cardiovascular events

Abstract

Combination therapy with rivaroxaban and aspirin successfully reduces the risk of cardiovascular events in patients who have coronary artery disease and/or peripheral artery disease.

1 .- 12 . (canceled) 
     
     
         13 . A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a population of human patients with coronary artery disease and/or peripheral artery disease, comprising administering to each human patient in the population rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial disease, wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75-100 mg daily, and wherein the hazard ratio for myocardial infarction, stroke, or cardiovascular death with the administration of rivaroxaban and aspirin compared to aspirin alone is 0.70-0.80 with a confidence interval of at least 0.56 to 0.96 and optionally the hazard ratio for major bleeding events with the administration of rivaroxaban and aspirin compared to aspirin alone is 1.60-1.90 with a confidence interval of at least 1.35 to 2.15. 
     
     
         14 . The method of  claim 13 , wherein 100 mg of aspirin is administered daily. 
     
     
         15 . The method of  claim 13 , wherein 81 mg of aspirin is administered daily. 
     
     
         16 . The method of  claim 13 , wherein 75 mg of aspirin is administered daily. 
     
     
         17 . A method of reducing the risk of stroke, myocardial infarction, or cardiovascular death, in a population of human patients with peripheral artery disease, comprising administering to each human patient in the population rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of stroke, myocardial infarction, or cardiovascular death, in a human patient with peripheral arterial disease, wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75-100 mg daily, and wherein the hazard ratio for stroke, myocardial infarction, or cardiovascular death is 0.50-0.60, with a 95% confidence interval of at least 0.30-1.10. 
     
     
         18 . (canceled)