Pradaxa shines in VTE study and may "overtake warfarin"

Boehringer Ingelheim has been buoyed by data from a major study which shows that Pradaxa could be as good, if not better, than warfarin, as a treatment for potentially life-threatening blood clots.

The company notes that “very positive results” have come out from the RE-COVER study, which it says is the most advanced trial programme assessing a novel oral anticoagulant in development for acute venous thromboemolism treatment. The data, presented at the American Society of Hematology meeting in New Orleans and published in the New England Journal of Medicine, reveal that 150mg of Pradaxa (dabigatran), taken twice-daily, showed equal efficacy compared to well-controlled warfarin, the standard treatment, at preventing recurrent VTE (2.4% vs. 2.1%).

Safety-wise, major bleeding was comparable between dabigatran (20 patients out of 1,274 patients on the Boehringer drug) and warfarin (24 patients out of 1,265). However, for any bleeds, Pradaxa showed a significant 29% reduction compared to warfarin and the German firm states that “these outstanding results were achieved without any evidence of liver problems”.

Sam Schulman of the McMaster University in Canada and principal investigator, said that warfarin is “a highly effective therapy when well-controlled within its narrow therapeutic range, as in clinical trials, but in the real world sufficient control is rarely achieved and maintained, leaving patients poorly protected from VTE or at risk of bleeding”. With dabigatran, “we have a therapy that protects our patients effectively and safely, without need for frequent laboratory monitoring and dose changes”.

The RE-COVER data comes three months after results were published from the 18,000-patient RE-LY study. They showed dabigatran “convincingly beating warfarin” in stroke prevention in atrial fibrillation. Boehringer chairman Andreas Barner said that “following the outstanding results from the RE-LY trial, these impressive new data mean dabigatran has the potential to benefit even more patients and overtake warfarin as the treatment of choice”.

He added that the company will submit these latest results, possibly before the end of the year, to the regulatory authorities “so that the results of this landmark trial can be put into a real-world setting”. Pradaxa is already available in over 40 countries for the primary prevention of VTE in adults who have undergone elective total hip or total knee replacement surgery, but approvals in these other indications would propel the drug towards blockbuster status. VTE is the third most common cardiovascular disease worldwide (after coronary heart disease and stroke). and affects around 1.5 million Europeans and three million Americans.

This latest data would appear to put Pradaxa in a prime position to challenge warfarin over rival drugs, notably Bayer/Johnson & Johnson's Xarelto (rivaroxaban; see article in today’s elert), but whether it can overtake warfarin is a big claim. Pradaxa may be more efficient and more convenient, but warfarin is about 15 times cheaper.