Dabigatran (Pradaxa(R)) is the first oral thrombin/Xa inhibitor on the market in the United States. This drug, after having been cleared for use by the FDA, has been commercially available since November 2010. The medication is prescribed to patients to prevent thromboembolic complications that are a result of atrial fibrillation. Though there were many studies done on Dabigatran (Pradaxa(R)) before approval, there has been a lack of large scale studies done in a real world setting. Most information researchers had about the drug was based on individual cases.
The “Dabigatran in the Real World” research project was done at a large anticoagulation clinic managing two thousand two hundred patients on oral therapy. The study worked as follows: Starting in November 2010, all clinic patients whose prescribing physicians asked for a switch from in therapy from warfarin to dabigatran were tracked prospectively for one year. Each patient served as his or her own control. The primary outcome measures focused on clinical events that led to the stoppage of either dabigatran or warfarin. Examples of these clinical events: episodes of thrombosis, bleeding, treatment-related death and any other events that required therapy with either agent to be discontinued.
Two of the main findings of the study are as follows:
- Complications necessitating therapy discontinuation occurred more frequently with Dabigatran (Pradaxa(R)) than with Warfarin.
- Complications related to Dabigatran (Pradaxa(R)) appeared very early in treatment, with patients reporting issues, on average, after just less than four months of therapy.