Two new analyses of more than 60,000 patients found dabigatran etexilate (Pradaxa) was linked to fewer major bleeds and strokes than warfarin.
In the studies, adult patients with non-valvular atrial fibrillation received a twice-daily dosage of 150 mg or 75 mg Pradaxa to reduce their risk of stroke and systemic embolism.
Compared with warfarin, Pradaxa was associated with a 25% reduction in major bleeding and a 23% reduction in strokes during the first analysis, according to a Boehringer Ingelheim press release.
In the second study, Pradaxa led to 27% fewer strokes and 13% fewer major bleeds compared with warfarin treatment. That analysis also found 35% fewer myocardial infarctions and a 36% improved survival rate among those taking Pradaxa.
“Real-world data is extremely valuable to physicians as they provide insights on how the efficacy-safety profile of a medicine is reflected in different patient populations in general practice,” said Professor Jörg Kreuzer, a practicing cardiologist and vice president of medicine therapeutic area cardiovascular at Boehringer Ingelheim, in a press release. “We are pleased by these latest results as they show that the safety and efficacy profile of Pradaxa originally established in the RE-LY clinical trial can also be achieved in routine care worldwide.”
Pradaxa has been available in the US market for more than 6 years and is approved in more than 100 countries, according to Boehringer Ingelheim.