[ad_1]
- The vascular dose of Xarelto® (rivaroxaban) (2.5 mg twice daily) should be made available to NHS England in combination with aspirin for the prevention of atherothrombotic events in adult patients at risk. elevated coronary artery disease or peripheral arterial disease from ischemic events.1
- Xarelto® (rivaroxaban) is the only oral anticoagulant (NACA) not badociated with vitamin K indicated alongside aspirin for stable coronary artery disease or symptomatic DPA.
- NICE's recommendation is based on evidence from the COMPASS study, the largest phase III study on rivaroxaban, that was stopped early after reaching its primary efficacy endpoint2. .
Reading, July 31, 2019 – The National Institute for Excellence in Health and Care (NICE) today released a favorable Final Evaluation Determination (FAD) project. recommending the use of Xarelto® (rivaroxaban) by the NHS in England at a dose of 2.5 mg twice daily (BID) in combination with aspirin (75-100 mg) once per day as an option to prevent atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral arterial disease presenting a high risk of ischemic events .1
The release of this DCP NICE project for Xarelto® (rivaroxaban) is based on evidence from the COMPASS study, the largest phase III study on rivaroxaban (27,395 patients). This study showed that rivaroxaban vascular dose, 2.5 mg twice daily combined with 100 mg aspirin daily, statistically significantly reduced the composite risk of cardiovascular death, stroke and stroke. or myocardial infarction (MI) (major adverse cardiovascular events; MACE) by 24% (relative risk reduction, ARR: 1.3%) compared to 100 mg aspirin once daily in patients with patients with stable atheromatous vascular disease (379 patients [4.1%] 496 patients [5.4%]; risk ratio, 0.76; 95% confidence interval [CI]0.66 to 0.86; P <0.001) .2
Bayer's Xarelto® (Rivaroxaban) Receives NICE's Positive Recommendation as an Option to Prevent Atherothrombotic Events in Adult Patients with Coronary Artery Disease or Symptomatic Peripheral Arterial Disease in England
• Vascular dose of Xarelto® (rivaroxaban) (2.5 mg twice daily) will be available via NHS England in combination with aspirin for the prevention of atherothrombotic events in adult patients with coronary artery disease or peripheral arterial disease (PAD) at a high speed. risk of ischemic events.1
• Xarelto® (rivaroxaban) is the only oral anticoagulant (NOAC) indicated for vitamin K antagonists, alongside aspirin for the treatment of stable coronary artery disease or symptomatic MAP.
• NICE's recommendation is based on evidence from the COMPASS study, the largest phase III study on rivaroxaban, which was stopped early after reaching its primary endpoint of badessment. effectiveness2.
In the COMPASS trial, in patients with stable coronary artery disease, the addition of rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily decreased major cardiovascular adverse events compared with aspirin once daily (347 mg / kg). [4%] from 8313 vs 460 [6%] 8261; HR 0 · 74, 95% CI 0 · 65-0 · 86, p <0. 0001) 3. In addition, patients with MAP who received rivaroxaban 2.5 mg twice daily in combination with 100 mg aspirin once daily also had fewer major cardiovascular events compared with to the group receiving 100 mg of aspirin once a day (126 [5%] from 2492 vs 174 [7%] 2504; HR 0.72, 95% CI 0.75-0-090, p = 0.007). 4
Rivaroxaban is an anticoagulant that targets factor Xa, an enzyme that acts at a key point in the blood coagulation process, by inhibiting its ability to generate thrombin. NICE recommends the use of rivaroxaban as part of a dual-pathway approach (in combination with aspirin). to prevent atherothrombotic events in high-risk patients. NICE defines patients with coronary heart disease at high risk of ischemic events as being those aged 65 years or older, patients with atherosclerosis in at least two vascular territories, or those with risk factors such as as smoking, diabetes, kidney dysfunction, heart failure or heart failure. a racing story.1
Dr. Derek Connolly, a COMPASS essayist, consultant interventional cardiologist and honorary clinical lecturer at the Birmingham City Hospital, said in Birmingham: "Cardiovascular disease remains the leading cause of years of life lost in the UK . There has been little recent progress in the medical management of patients with coronary artery disease. [CAD] and peripheral arterial [PAD] to protect them from strokes or heart attacks "
"The COMPASS trial showed that adding a vascular dose of rivaroxaban (2.5 mg twice daily) to low-dose aspirin significantly reduced vascular events. The big reduction of events [such as strokes], outweighs the increase in the number of major haemorrhagic events observed. Conducted in more than 30 countries, including the UK, COMPASS has been one of the largest ever trials of oral antithrombotic therapy, yielding robust results, overall, and particularly for subgroups of key patients at high risk of recurrent events, such as those with kidney failure. or "mild heart failure" stable. "The rivaroxaban vascular dose in combination with aspirin is the first treatment of this type in this patient population and this NICE recommendation provides clinicians with an important additional option for the treatment of patients at risk. major adverse cardiac events such as death, stroke or infarction. "
Dr. Matthew Fay, a family physician in Queensbury, Bradford, particularly interested in cardiology, said, "We are all too aware that cardiovascular disease is an unacceptable burden, since it accounts for one-quarter of all deaths in Canada. United Kingdom. As general practitioners, we are always looking for new options to protect our patients with cardiovascular disease, especially as the risk of atherothrombotic events remains high despite current treatment options.
The COMPASS study showed that the vascular dose of rivaroxaban (2.5 mg twice daily) is an effective option for patients with coronary artery disease and peripheral artery and that it is promising for help patients with these conditions. I am sure that general practitioners from all over England will join me in welcoming this decision from NICE. "
Jo Jerrome, CEO of Thrombosis UK, said: "Cardiovascular disease is one of the leading causes of death in the UK, with more than 460 deaths a day. Today's positive recommendation from NICE is great news for thousands of at-risk patients across the country. "
More than 7 million people live with cardiovascular disease in the UK. It is estimated that cardiovascular disease, including CAD and PAD, is responsible for 170,000 deaths each year in the UK, accounting for a quarter of all annual deaths.6 Lars Bruening, CEO of Bayer UK & Ireland, said, "Bayer's legacy is long and fruitful in cardiology. The NICE recommendation provides individuals with a high risk of coronary artery disease and symptomatic DAP an effective treatment option that will provide additional tailored protection against atherothrombosis. Ten years after the introduction of rivaroxaban in the UK, we continue to see the long-lasting impact of this drug on patients treated according to its authorized indications – and now this new population of patients with unmet past needs can be taken into account. account ".
The publication of the DCP NICE project for Xarelto (rivaroxaban) was approved by the European Commission (EC) in August 20187 for the regimen of rivaroxaban 2.5 mg twice daily and aspirin 75-100 mg. once a day for the prevention of atherothrombotic events in adult CAD patients or symptomatic DPA at high risk of ischemic events. Rivaroxaban is the most widely reported NACO in the world. It is approved in the United Kingdom for: 8,9,10
• the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors;
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults • Prevention of venous thromboembolism (VTE) in adult patients undergoing scheduled hip or knee replacement surgery
• Prevention of atherothrombotic events in adult patients after acute coronary syndrome (ACS) with elevated cardiac biomarkers, co-administered with aspirin alone or with aspirin plus clopidogrel or ticlopidine
• The prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral arterial disease at high risk of ischemic events.
It is recommended that physicians evaluate the risk of bleeding from a person before considering rivaroxaban. Treatment should be initiated once an informed discussion has taken place, badessing the risk of atherothrombosis events in relation to the risk of bleeding.1
PP-XAR-GB-0540 Preparation Date: July 2019
Please refer to the Summary of Product Characteristics for Xarelto® for more information.
Source link
