![]() ![]() A two-cohort comparison study included patients on andexanet alpha from the ANNEXA-4 study and a synthetic control arm of patients on 4-factor prothrombin complex concentrate (4F-PCC) admitted within a US healthcare system from December 2016 to August 2020. ![]() In a substudy of ANNEXA-4 ( ANNEXA-4 Substudy), which evaluated the efficacy and safety of andexanet in a subgroup of patients with intracranial hemorrhage (ICH), median percent change in anti-FXa levels from baseline to nadir for XARELTO-treated patients showed a decrease of 92.6%.Among patients who received XARELTO, anti-FXa activity was reduced by 92% from baseline to end of andexanet bolus administration.ANNEXA-4 was a multicenter, prospective study that assessed the efficacy and safety of andexanet in patients with acute major bleeding within 18 hours after administration of an FXa inhibitor, including XARELTO.In part 2 of the study, andexanet administered as a bolus plus a 2-hour infusion vs placebo reduced anti-FXa activity to a greater extent (97%☒% vs 45☑2% PIn part 1 of the study, andexanet administered as a rapid bolus (within 2-5 minutes) vs placebo reduced anti-factor Xa (FXa) activity to a greater extent (92%☑1% vs 18%☑5% PANNEXA-R was a phase 3, two-part, randomized study that evaluated the safety and efficacy of andexanet (Andexxa) to reverse the anticoagulant effects of XARELTO in older healthy subjects. ![]()
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