FDA has approved twice-daily Xarelto 2.5-mg dose to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease
The U.S. Food and Drug Administration ( FDA ) has approved Xarelto ( Rivaroxaban ) to reduce the risk of major cardiovascular events, such as cardiovascular death, myocardial infarction and stroke, in people with chronic coronary ( CAD ) or peripheral artery disease ( PAD ).
Xarelto is now the first and only factor Xa inhibitor approved for patients living with these conditions.
This new indication is based on results from the landmark COMPASS trial, which showed a significant 24% reduction of the risk of major cardiovascular events in patients with chronic CAD and/or PAD with the Rivaroxaban 2.5-mg vascular dose twice daily plus Aspirin ( Acetylsalicylic acid; ASA ) 100 mg once daily, compared to Aspirin alone.
This finding was driven by a 42% reduction in stroke, 22% reduction in cardiovascular death and 14% reduction in myocardial infarction.
The risk of major bleeding was significantly higher in patients taking the Rivaroxaban / Aspirin regimen compared to Aspirin alone, with no significant increase in fatal or intracranial bleeds.
Both chronic CAD and PAD occur when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, potentially limiting blood flow to parts of the body.
Known as atherosclerosis, this disease is rarely fatal, but is the most frequent underlying cause of chronic CAD and PAD, which affect 16.5 million and 10 million Americans, respectively, 13 million of whom are currently diagnosed. When left untreated, atherosclerosis can lead to serious problems, including myocardial infarction, stroke and death.
COMPASS, a phase 3 clinical study of 27,395 patients with chronic CAD or PAD from 33 countries, examined the use of Rivaroxaban, alone or in combination with Aspirin, for the long-term prevention of major adverse cardiovascular events, including myocardial infarction, stroke and cardiovascular death.
In February 2017, COMPASS was stopped early for efficacy based on recommendation of the Independent Data and Safety Monitoring Board who observed a consistent difference in the primary outcome in favor of Rivaroxaban 2.5 mg plus Aspirin.
Xarelto is a prescription medicine used to:
a) reduce the risk of stroke and blood clots in people with atrial fibrillation that is not caused by a heart valve problem;
b) treat blood clots in the veins of your legs ( deep vein thrombosis or DVT ) or lungs ( pulmonary embolism or PE );
c) reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months;
d) help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery. ( Xagena )
Source: Janssen Pharmaceutical, 2018