28 Aug 2012, BioSpectrum Bureau , BioSpectrum
Singapore: The combined treatment experience with Boehringer Ingelheim's Pradaxa has crossed one million patient year in the prevention of thromboembolic events in patients after surgery and in patients with non-valvular atrial fibrillation (AF), providing the greatest body of clinical experience among all novel oral anticoagulants.
One million patient years of treatment experience is unprecedented for a novel oral anticoagulant and highlights a broad adoption of Pradaxa in more than 70 countries worldwide following regulatory approvals in stroke prevention in AF. This level of clinical use shows strong endorsement for the substantial benefits Pradaxa has demonstrated in the RE-LY trial and for its positive benefit-risk profile, as recently reconfirmed by the European Medicines Agency.
Professor Klaus Dugi, corporate senior VP, Medicine, Boehringer Ingelheim, said that, "It is great to see this treatment being accepted and adopted all over the world for the benefit of patients being effectively protected against thromboembolic events. One million patient-years is an important milestone, but even more important is how many strokes our treatment already is likely to have prevented, protecting patients and their families from the impact of this devastating event."
The benefit of Pradaxa in stroke prevention in patients with non-valvular AF compared to no-treatment can be derived from the reduction in the risk of stroke observed in the pivotal clinical RE-LY study and by comparing against historical trials in AF patients receiving no treatment.
Taking into account the overall real-world exposure achieved since the first approval of Pradaxa in this indication, it can be calculated that Pradaxa may have already prevented up to 40,000 strokes in non-valvular AF patients, compared to no treatment.