Noticias

Noticias

  • Título: Secondary analysis of AMPLIFY-EXT examining predictors of hospitalisation presented at ESC congress
  • Fecha: 30-08-2014

  • PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced results of a pre-specified secondary analysis of the Eliquis Phase 3 AMPLIFY-EXT trial (Apixaban after the initial Management of PuLmonary 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 results of this AMPLIFY-EXT secondary analysis showed that Eliquis significantlyreduced the risk of hospitalization, irrespective of other variables,” said Dr. Alexander T. Cohen, study investigator and consultant physician, Department of Hematology, Guy’s and St. Thomas’ Hospitals, King’s College, London. “The findings from this secondary analysis provide additional support for extended anticoagulation with Eliquisin VTE patients.”

    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. The secondary analysis presented today 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 theEliquis 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 the Eliquis 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.

    A total of 14 Bristol-Myers Squibb/Pfizer alliance-sponsored abstracts, including the AMPLIFY-EXT pre-specified secondary analysis described above, were accepted for presentation at the ESC Congress 2014.



  • Fuente: endovascular.es