Eliquis Effective in Reducing All-Cause Hospitalization in Phase 3 Trial
Bristol-Myers Squibb and Pfizer announced results from the pre-specified secondary analysis of the Phase 3 AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment) trial with Eliquis (apixaban). The analysis evaluated clinical and demographic predictors of all-cause hospitalization in patients with venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE).
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 6–12 months of anticoagulation therapy.
The secondary analysis demonstrated that, compared with placebo, Eliquis 2.5mg (P=0.032) and 5mg (P=0.004) were both associated with significant reduction in all-cause hospitalization. During the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization vs. placebo. This effect was independent of other variables including renal function, the only other significant predictor of hospitalization in the AMPLIFY-EXT population. The following factors were clinically significant and independent predictors of all-cause hospitalization during the trial:
- Eliquis 2.5mg vs. placebo (HR=0.65, 95% CI=0.43–0.96);
- Eliquis 5mg vs. placebo (HR=0.54, 95% CI=0.36–0.83); and
- Severe or moderate renal impairment vs. normal renal function (HR=2.26, 95% CI=1.30–3.92).
Eliquis is already approved to reduce risk of stroke and systemic embolism in patients with nonvalvularatrial fibrillation (AF); for prophylaxis of DVT, which may lead to pulmonary embolism in patients who have undergone hip or knee replacement surgery; and for the treatment of DVT and PE, and to reduce risk of recurrent DVT and PE following initial therapy.
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