Reason for request

Inclusion

No clinical benefit demonstrated by comparison with other oral anticoagulants in the prevention of stroke and systemic embolism associated with non-valvular atrial fibrillation in patients with one or more risk factor(s)

 

  • LIXIANA (30 mg and 60 mg) has Marketing Authorisation in prevention of stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation (NVAF) and at least one risk factor.
  • The 15 mg dose is reserved for switching from treatment with LIXIANA to AVK.
  • Its efficacy is non-inferior to that of warfarin, without increase of haemorrhagic risk. No clinical studies have compared it to other oral anticoagulants.
  • Data are limited in patients over 80 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

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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