![]() Inadequate clinical evaluation" Prescrire International 2020 29 (217): 173-176. Source: "Andexanet alfa (Ondexxya°) as an antidote to xabans. ![]() When bleeding occurs in a patient receiving a xaban, the key action is to put in place proven emergency supportive measures. Further evaluation is needed, with the aim of providing comparative data based on clinical criteria. NOTHING NEW As of 2020, the efficacy of andexanet alfa has not been demonstrated using clinical endpoints. Andexanet alfa, a modified recombinant inactive FXa, was specifically designed to reverse the anticoagulation induced by FXa inhibitors 1.Andexanet alfa carries a risk of infusion reactions. It is not known whether these events were linked to withdrawal of the anticoagulant in patients at risk of thrombosis, or to a procoagulant effect of andexanet alfa. 10% of the patients enrolled in this trial had at least one thromboembolic event during the 30 days following the infusion.None of the analyses provided enables the potential clinical effectiveness of andexanet alfa in controlling haemorrhage to be demonstrated or evaluated. After one month, 15% of the patients had died. All the patients received andexanet alfa. Its evaluation comprises a single, non-comparative clinical trial in 352 patients who had major bleeding while receiving a factor Xa inhibitor.It has been authorised in the European Union as an antidote for use in patients with severe bleeding who are receiving apixaban or rivaroxaban. Andexanet alfa is a modified factor Xa, lacking enzymatic activity. ![]() ![]()
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