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LIXIANA (edoxaban), oral anticoagulant
CARDIOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jan 13 2017
Reason for request
Inclusion
No clinical benefit demonstrated by comparison with other oral anticoagulants in the treatment of deep vein thrombosis and pulmonary embolism and prevention of their recurrence
- LIXIANA (30 mg and 60 mg) has Marketing Authorisation in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of their recurrence.
- The 15 mg dose is reserved for switching from treatment with LIXIANA to AVK.
- It is indicated when switching from treatment with heparin.
- The efficacy of heparin/edoxaban was non-inferior to that of heparin/warfarin at 12 months, with a haemorrhagic risk that seems similar.
- Data are limited in patients over 75 years of age, patients with renal impairment and patients with low body weight.
- There is no available means of monitoring the degree of anticoagulation achieved by the product and no available antidote should it prove necessary to rapidly abolish the anticoagulant effect.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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