Boehringer Ingelheim will be pleased by a new analysis of clinical data on its bloodthinner Pradaxa, published in The Lancet Neurology, which concluded that the drug lowers the risk of major bleeding compared with veteran rival warfarin.
Major bleeds in patients taking bloodthinners are a primary treatment concern, but a sub-group analysis of the landmark Randomised Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial - the largest atrial fibrillation (AF) outcomes trial ever completed, with 18,113 patients worldwide - showed that patients with prior stroke or transient ischemic attack could “benefit substantially” from using Boehringer’s drug, the firm said.
The new analysis, which included 3,623 AF patients who had suffered a stroke or TIA before enrolling in the trial, showed that the rate of major bleeding was significantly lower in patients on Pradaxa 110mg (dabigatran etexilate) and similar in those taking 150mg compared with well-controlled warfarin. Moreover, both doses of Pradaxa also significantly reduced intracranial bleeds versus warfarin, according to Boehringer.
“These findings support the overall striking results of RE-LY in the prevention of stroke and systemic embolism of Pradaxa, within a patient sub-group who are at 2.5 times increased risk compared with a typical AF patient without previous stroke or TIA, who themselves are already at 5-times increased risk,” Boehringer noted, commenting on the results.
US regulators approved Pradaxa for stroke risk reduction in non-valvular atrial fibrillation just last month, marking the first approval of a new oral anticoagulant in the country in more than 50 years, and while the analysis found the effects Boehringer’s drug on stroke or systemic embolism to be similar to those of warfarin, the former’s potential association with a lower risk of major bleeds could give it a significant edge over its competitor.
New data from the RE-LY trial and Pradaxa will be available at the American Heart Association Scientific Sessions in Chicago next week, Boehringer said.