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 | - | 
Clinical Added Value
| no clinical added value | - | 
Therapeutic use
| - | 
-
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