Noticias

Noticias

  • Título: Pradaxa Now FDA-Approved for Treatment of Deep Venous Thrombosis and Pulmonary Embolism
  • Fecha: 02-05-2014

  • TheUS Food and Drug Administration (FDA) has approved Pradaxa (dabigatranetexilate mesylate) for the treatment of deep venous thrombosis (DVT) andpulmonary embolism (PE) in patients who have already been treated with aparenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrentthrombotic and embolic events in patients who have been previously treated.

    The approval is basedon results from four global Phase III studies evaluating the efficacy and safetyof Pradaxa in the treatment of venous thromboembolic disease. The RE-COVER and RE-COVER II trials, which included patientswith DVT and PE who were treated with parenteral anticoagulant therapy for 5 to10 days, showed Pradaxa was non-inferior to warfarin in reducing DVT and PEafter a median of 174 days of treatment, and was associated with lower rates ofoverall bleeding and a higher rate of any gastrointestinal bleeding (3.1% vs2.4%). The RE-MEDY trial, which included patientswho had been previously treated for an acute DVT and PE with anticoagulanttherapy for 3 to 12 months, showed Pradaxa was noninferior to warfarin inreducing DVT and PE after a median of 534 days of treatment, and was associatedwith lower rates of overall bleeding and a higher rate of any gastrointestinalbleeding (3.1% vs 2.2%).

    The RE-SONATE trial, which included patientswho had been previously treated for an acute DVT and PE with anticoagulanttherapy for six to 18 months, showed Pradaxa reduced the risk of DVT and PErecurrence by 92% compared to placebo after a median of 182 days of treatment:0.4% vs 5.6%. Pradaxa was associated with higher rates of any bleeding (10.5%vs 6.1%), clinically relevant non-major bleeding (5.0% vs 2.0%), andgastrointestinal bleeding (0.7% vs. 0.3%) compared to placebo.

    This represents asignificant addition to our armamentarium to manage a large group of patients sufferingfrom venous thromboembolic problems. Avoiding warfarin therapy is likely toprove beneficial for many.



  • Fuente: endovascular.es