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ELIQUIS (apixaban), oral anticoagulant

CARDIOLOGY - New indication
Opinions on drugs - Posted on Sep 14 2015

Reason for request

Extension of indication

No clinical benefit demonstrated in the treatment of deep vein thrombosis and pulmonary embolism and prevention of their recurrence in adults by comparison with other oral anticoagulants

  • ELIQUIS has Marketing Authorisation in adults in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of their recurrence.
  • Its short-term efficacy (6 months) was non-inferior to that of enoxaparin/warfarin in the initial treatment of DVT and PE after a first episode, which is most often idiopathic, with a lower risk of haemorrhage.
  • Its long-term efficacy (12 months) versus placebo has been demonstrated in the prevention of recurrence of DVT and EP and of deaths of any cause, with no evidence of an increase in the risk of haemorrhage.
  • There is no available means of monitoring the degree of anticoagulation achieved by the product and no antidote -available in case of need for rapid interruption of the anticoagulant effect.

Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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