Rivaroxaban for CV Event Reduction in CAD and PAD Patients Is Accepted by FDA
The extension changes the attention to aiming “atherothrombosis” in certain patients with chronic stable disease.
New signals for rivaroxaban (Xarelto; Bayer/Janssen) has been included by the US Food and Drug Administration (FDA) to comprise the patients’ treatment with stable atherosclerotic vascular disease, both CAD and PAD, making the factor Xa inhibitor to become the first direct oral anticoagulant cleared for this use.
On the Thursday announcement made by Janssen, the extended indications, are supported by the results of the 27,395-patient COMPASS trial, which had been discontinued ahead of time because of what the drug makers called “overwhelming efficacy.”
The key outcomes of the trial displayed that compared with just low-dose aspirin being used, a combination of low-dose rivaroxaban (2.5 mg twice daily) and low-dose aspirin (100 mg/day) decreased the risk of a compound of cardiovascular death, MI, or stroke by an absolute 1.3%, while surging the danger of major bleeding by an absolute 1.2%. Furthermore, risks of major adverse limb events, major amputation, and a complex of major adverse cardiovascular and limb events are diminished in the subsection of patients with PAD, by low-dose rivaroxaban and aspirin only.
Professionals who had interviews with TCTMD last year forecasted that the trial would make an important effect, nevertheless they also noticed several possible hindrances to applying the approach researched in COMPASS, including clinical inertia, worries about cost and bleeding, and a common lack of awareness of the discoveries among doctors.
Erin Michos, who is a MD (Johns Hopkins Medicine, Baltimore, MD), was asked to make a comment on the FDA’s extension of rivaroxaban’s indications, said she wasn’t surprised.
Michos highlighted that the combination of low doses of rivaroxaban and aspirin might as well lessen the risk of all-cause mortality by a relative 18% (though the variance fell short of the threshold for statistical significance used in the trial). “While this did come at the cost of an increased risk for bleeding, reduction in death matters. It’s meaningful,” she said.
For the matter of conducting the medthod into practice, Michos said she’d likely use it more in patients with combined CAD and PAD than in lower-risk patients with only CAD, citing the relative lack of chosen therapies for PAD.
However, the associated costs for patients are still a concern, and physicians should not discard all the other possibilities presently available for secondary prevention in the excitement of a new approval, Michos said. Thus, patient selection is key.
The new suggestion includes numerous others already found on rivaroxaban’s label, comprising stroke prevention in nonvalvular A-fib, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), decrease in risk of recurrent DVT and PE, and prophylaxis of DVT in patients undergoing knee or hip replacement surgery.
Rivaroxaban is continually tested in various places, failing in some cases. In the NAVIGATE ESUS trial of patients with embolic strokes of undetermined source and the COMMANDER HF trial of patients with heart failure and CAD but no A-fib, the drug was ineffective. The GALILEO trial, which had been analysing the rivaroxaban-based anticoagulation strategy in patients who had undergone successful TAVR, was put an end prematurely because of an increased risk of all-cause mortality, thromboembolic events, and bleeding.
On the Thursday announcement made by Janssen, the extended indications, are supported by the results of the 27,395-patient COMPASS trial, which had been discontinued ahead of time because of what the drug makers called “overwhelming efficacy.”
The key outcomes of the trial displayed that compared with just low-dose aspirin being used, a combination of low-dose rivaroxaban (2.5 mg twice daily) and low-dose aspirin (100 mg/day) decreased the risk of a compound of cardiovascular death, MI, or stroke by an absolute 1.3%, while surging the danger of major bleeding by an absolute 1.2%. Furthermore, risks of major adverse limb events, major amputation, and a complex of major adverse cardiovascular and limb events are diminished in the subsection of patients with PAD, by low-dose rivaroxaban and aspirin only.
Professionals who had interviews with TCTMD last year forecasted that the trial would make an important effect, nevertheless they also noticed several possible hindrances to applying the approach researched in COMPASS, including clinical inertia, worries about cost and bleeding, and a common lack of awareness of the discoveries among doctors.
Erin Michos, who is a MD (Johns Hopkins Medicine, Baltimore, MD), was asked to make a comment on the FDA’s extension of rivaroxaban’s indications, said she wasn’t surprised.
Michos highlighted that the combination of low doses of rivaroxaban and aspirin might as well lessen the risk of all-cause mortality by a relative 18% (though the variance fell short of the threshold for statistical significance used in the trial). “While this did come at the cost of an increased risk for bleeding, reduction in death matters. It’s meaningful,” she said.
For the matter of conducting the medthod into practice, Michos said she’d likely use it more in patients with combined CAD and PAD than in lower-risk patients with only CAD, citing the relative lack of chosen therapies for PAD.
However, the associated costs for patients are still a concern, and physicians should not discard all the other possibilities presently available for secondary prevention in the excitement of a new approval, Michos said. Thus, patient selection is key.
The new suggestion includes numerous others already found on rivaroxaban’s label, comprising stroke prevention in nonvalvular A-fib, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), decrease in risk of recurrent DVT and PE, and prophylaxis of DVT in patients undergoing knee or hip replacement surgery.
Rivaroxaban is continually tested in various places, failing in some cases. In the NAVIGATE ESUS trial of patients with embolic strokes of undetermined source and the COMMANDER HF trial of patients with heart failure and CAD but no A-fib, the drug was ineffective. The GALILEO trial, which had been analysing the rivaroxaban-based anticoagulation strategy in patients who had undergone successful TAVR, was put an end prematurely because of an increased risk of all-cause mortality, thromboembolic events, and bleeding.
Source
Janssen. US FDA approves Xarelto (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Published on: October 11, 2018. Accessed on: October 15, 2018.
Janssen. US FDA approves Xarelto (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Published on: October 11, 2018. Accessed on: October 15, 2018.