Pradaxa linked to higher rates of complications than warfarin in early results of trial study


Pradaxa linked to higher rates of complications than warfarin in early results of trial studyThe makers of the new blood-thinning drug Pradaxa have reported that initial results from a clinical study comparing the drug’s efficacy against its predecessor warfarin have painted a bleak future for its own new drug.

According to a news release from the Thrombosis and Hemostasis Summit of North America, Alere Inc. reported that a study conducted by one of its subsidiary companies on Pradaxa versus warfarin as a drug treatment for thinning blood to prevent heart attack, stroke, and sudden death revealed that the new drug was linked to a higher rate of serious complications than its predecessor drug, used for years without an abnormal adverse event rate.

Among the clinical trial participants more people taking Pradaxa suffered adverse reactions and side effects that forced them to stop their drug treatment than people taking warfarin (Coumadin). In addition to that bit of bad news for Alere, Pradaxa was also associated with a faster rate of patients experiencing those complications. Patients who had trouble after starting Pradaxa experienced that problem most often in the first four months of the therapy.

The release details the study method on its 2,200 participants:

Beginning in November 2010, all clinic patients whose prescribing physicians requested a switch from warfarin to dabigatran were tracked prospectively for a one-year period. Each patient served as his or her own control, and primary outcome measures focused on clinical events that led to the discontinuation of dabigatran or warfarin.

Severe adverse events that caused a treatment to stop and switch to the other drug were thrombosis, severe bleeding episodes, and sudden death.