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Xarelto single pill backed by NICE in final guidance
Tuesday 24th July 2012
Bayer HealthCareâ€™s oral anticoagulant tablet XareltoÂ® (rivaroxaban) has today been recommended for NHS use in Final Guidance by the National Institute for Health and Clinical Excellence (NICE) as a single-drug therapy for the treatment of deep vein thrombosis (DVT) and prevention of recurrent deep vein thrombosis and pulmonary embolism (PE) after a diagnosis of acute deep vein thrombosis in adults.
With the publication of this guidance, DVT patients now have an alternative to the current standard of care which can help simplify treatment. The current approach is a dual-drug regimen consisting of low molecular weight heparin (LMWH) administered by subcutaneous injection, followed by a vitamin K antagonist (VKA) such as warfarin.
The NICE Appraisal Committee, which reviewed the evidence for Xarelto, acknowledged the limitations of warfarin therapy and recognised the advantages of rivaroxaban, including removing the need for routine INR monitoring and its oral formulation compared to LMWH, which is injected.
DVT presents a major health challenge to the NHS. If left untreated, DVT blood clots can result in PE which can be rapidly fatal. This makes the initial treatment and secondary prevention of DVT vitally important.
Recent analysis of linked UK hospital and primary care databases (General Practice Research Database, Hospital Episodes Statistics database and Office for National Statistics vital status linkage data) showed an annual incidence for first DVTs of 87.1 per 100.000 cases in adults.
This would be equivalent to 43,475 cases in the UK in 2012. This potentially life threatening condition is also a major cause of morbidity with over 60% of patients with proximal symptomatic DVT developing Post Thrombotic Syndrome within two years.The total cost to the NHS (direct and indirect) of managing DVT and PE is estimated to be ÂŁ640 million.
The NICE published guidance states:
â€˘ Rivaroxaban is recommended as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after a diagnosis of acute deep vein thrombosis in adults
â€śTodayâ€™s NICE guidance on rivaroxaban will broaden patient access to include an important new therapy choice,â€ť said Dr Gerry Dolan, Consultant Haematologist, Department of Haematology, Nottingham University Hospital, UK. â€śRivaroxaban is proven as an effective agent for DVT treatment which removes some of the challenging constraints of current standard therapy, and can help re-shape and improve anticoagulation services by reducing our reliance on regular coagulation monitoring.â€ť
The guidance follows a close review by NICE of the Phase III EINSTEIN-DVT study, which demonstrated rivaroxaban to be an effective DVT treatment, with non-inferiority to enoxaparin/VKA in the primary efficacy endpoint and a favourable safety profile compared to the current standard dual therapy. In EINSTEIN-DVT, rivaroxaban delivered a statistically significant improved net clinical benefit (a pre-specified outcome defined as the composite of the primary efficacy outcome plus major bleeding, and a standard measure for anticoagulation clinical trials), compared to standard therapy (2.9% vs. 4.2%, respectively, p=0.03), as well as a comparable rates of major and non-major clinically relevant bleeding.6 The Appraisal Committee concluded that treatment with rivaroxaban had an acceptable adverse event profile compared with the combination LMWH and warfarin
In an additional study, EINSTEIN-EXT, rivaroxaban demonstrated a highly statistically significant risk reduction in the incidence of venous thrombosis following longer-term therapy (six or 12 months) to prevent recurrence of venous blood clots in comparison to placebo.
Xarelto is the first in a class of drugs known as Factor Xa inhibitors, which act at a critical point in the blood-clotting process to prevent the formation of clots. The features of oral Factor Xa inhibitors include no routine anticoagulation monitoring, predictable effects and a lower risk of drug-drug or food interactions by comparison to warfarin. Xarelto is the first oral Factor Xa inhibitor to be licensed for use in three indications â€“ the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following a diagnosis of an acute DVT in adults; the prevention of stroke and non-CNS systemic embolism in eligible adult patients with non-valvular atrial fibrillation and one or more risk factors for stroke; and the prevention of venous thromboembolism in patients undergoing elective hip or knee replacement surgery.
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