XARELTO (rivaroxaban), oral anticoagulant
CARDIOLOGY - Update
Opinions on drugs - Posted on Jan 13 2017
Reason for request
Re-assessment of the actual benefit and the improvement in actual benefit
No clinical advantage demonstrated in prolonged treatment beyond 12 months in prevention of recurrences of pulmonary embolism and deep vein thrombosis in adults
- XARELTO (15 mg and 20 mg) has a Marketing Authorisation in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrences as DVT and PE in adults.
- Its effectiveness is not inferior to that of enoxaparin followed by warfarin and its risk of bleeding is similar up to 12 months of treatment.
- Its benefit in the long-term prevention of recurrences beyond 12 months and for up to 2 years was evaluated versus placebo. The selection criteria for patients who may benefit from this strategy cannot be clearly defined and the decision must be made on a case-by-case basis.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments