Date: 2014-08-30
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European Society of Cardiology (ESC) Congress 2014
Company: BMS (USA - NY) Pfizer (USA - NY)
Product: Eliquis® (apixaban)
Action
mechanism: Eliquis® (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, Eliquis® decreases thrombin generation and blood clot formation.
Disease: prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: AMPLIFY-EXT was a randomized, double-blind, placebo-controlled extended treatment superiority study with 12 months of treatment plus one month follow-up in patients with VTE who completed six to 12 months of anticoagulation therapy.
Latest
news: * On August 30, 2014, BMS and Pfizer announced results of a pre-specified secondary analysis of the Eliquis® Phase 3 AMPLIFY-EXT trial (Apixaban after the initial Management ofPuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment). The analysis evaluated clinical and demographic predictors of all-cause hospitalization in patients with VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Results from this analysis demonstrated that during the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization versus placebo. This effect was independent of other variables including renal function, the only other significant predictor of hospitalization in the AMPLIFY-EXT population. These data were presented during an oral session today in Barcelona, Spain, at the ESC Congress 2014. The secondary analysis presented showed that, compared with placebo, Eliquis 2.5 mg (p=0.032) and 5 mg (p=0.004) were both associated with significant reduction in all-cause hospitalization. Of the 2,486 patients included in the AMPLIFY-EXT trial, 138 patients were hospitalized at least once, including 62 (7.48%) in the placebo group (n=829), 42 (5.00%) in the Eliquis 2.5 mg group (n=840), and 34 (4.18%) in the Eliquis 5 mg group (n=813). Of the first hospitalizations in the placebo group, a total of 32 (51.6%) were attributed to VTE recurrence versus six (17.7%) in theEliquis 5 mg group and 11 (26.2%) in the Eliquis 2.5 mg group.
The following factors were clinically significant and independent predictors of all-cause hospitalization during the trial:
Eliquis 2.5 mg versus placebo (HR=0.65, 95% CI=0.43-0.96)
Eliquis 5 mg versus placebo (HR=0.54, 95% CI=0.36-0.83)
Severe or moderate renal impairment versus normal renal function (HR=2.26, 95% CI=1.30-3.92).
Sex, age, baseline body weight and type of VTE did not significantly predict hospitalization.
Eliquis® is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the United States, European Union, Japan and a number of other countries around the world. Eliquis® is approved for prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery in the United States, European Union and a number of other countries around the world. Eliquis® is not approved for this indication in Japan. Eliquis is approved for the treatment of DVT and PE, and prevention of recurrent DVT and PE following initial therapy in the United States and European Union.
