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BMS and Pfizer report positive results from Phase III AMPLIFY-EXT trial of Eliquis

Bristol-Myers Squibb (BMS) and Pfizer have reported results of a pre-specified secondary analysis of the Phase III AMPLIFY-EXT trial of Eliquis in patients with venous thromboembolism (VTE).

The trial evaluated clinical and demographic predictors of all-cause hospitalization in patients with VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

During the 12-month extended treatment of VTE, Eliquis has shown to have reduced the risk of hospitalization versus placebo.

The randomized, double-blind, placebo-controlled extended treatment superiority AMPLIFY-EXT trial included 12 months of treatment plus one month follow-up in patients with VTE who completed six to 12 months of anticoagulation therapy.

The secondary analysis showed that, compared with placebo, Eliquis 2.5mg and 5mg were both associated with significant reduction in all-cause hospitalization.

A total of 2,486 patients were included in the AMPLIFY-EXT trial, out of which 138 patients were hospitalized at least once, including 62 in the placebo group, 42 in the Eliquis 2.5mg group and 34 in the Eliquis 5mg group.

Guy’s and St. Thomas’ Hospitals consultant physician, Department of Hematology and study investigator Alexander Cohen said the results of this AMPLIFY-EXT secondary analysis showed that Eliquis significantly reduced the risk of hospitalization, irrespective of other variables.

"The findings from this secondary analysis provide additional support for extended anticoagulation with Eliquis in VTE patients," Cohen said.