Results from Phase III AMPLIFY trial of Eliquis (apixaban) in venous thromboembolism published online- BMS/Pfizer

BMS and Pfizer have announced results from a post-hoc early time course subanalysis of the Phase III AMPLIFY trial which demonstrated Eliquis (apixaban) was comparable to conventional therapy (subcutaneous enoxaparin overlapped and followed by oral warfarin) in recurrent venous thrombo-embolism (VTE) and VTE-related death with significantly less major bleeding during the first 7, 21 and 90 days after starting treatment. These data were published in Thrombosis and Haemostasis.

The results of the subanalyses at each pre-specified time interval were consistent with the overall results of the AMPLIFY trial at 6 months, which demonstrated non-inferiority of Eliquis versus conventional therapy in the primary efficacy endpoint of recurrent VTE and VTE-related death, and superiority in the primary safety endpoint by showing significantly fewer major bleeding events, with a 69 percent relative risk reduction (RRR) (absolute risk reduction [ARR] of 1.1 percentage points compared to conventional therapy. In this post-hoc early time course subanalysis, recurrent VTE and VTE-related death at 7, 21, and 90 days after starting treatment occurred in 18 (0.7 percent), 29 (1.1 percent), and 46 (1.8 percent), patients who were given Eliquis, respectively, and in 23 (0.9 percent), 35 (1.3 percent), and 58 (2.2 percent) patients given conventional therapy, respectively. Outcomes at each time point were similar in patients by index event (deep vein thrombosis (DVT) alone or pulmonary embolism (PE) with or without DVT) and were consistent with the results for the entire study period.

Major bleeding at the corresponding time points occurred in 3 (0.1 percent), 5 (0.2 percent), and 11 (0.4 percent) patients, who received Eliquis, respectively, and in 16 (0.6 percent), 26 (1.0 percent), and 38 (1.4 percent) patients given conventional therapy, respectively. Eliquis was non-inferior to conventional therapy in recurrent VTE and VTE-related death at each time point analyzed, with no excess of early recurrences; and patients treated with Eliquis were less likely to have major bleeding early in the course of treatment than those treated with conventional therapy.