Emergence of Dabigatran for Prevention and Treatment of Blood Clots

Implications: These data help strengthen the growing perception that oral agents in general, direct thrombin inhibitors in particular, and perhaps specifically dabigatran, represent the future of anticoagulation therapy.  Safety data are of paramount importance, given the prior failure of ximelagatran in this respect, and thus far dabigatran indeed has avoided causing similar liver toxicity.  Ongoing studies of dabigatran, and of other oral agents such as the factor Xa inhibitors, in treatment of venous thrombosis and pulmonary embolism will add critical information in this area.

Analysis: As further data become available on new oral agents for prevention and treatment of venous thrombosis and pulmonary embolism (the same basic disease process and collectively known as VTE), it becomes increasingly clear that the future for oral agents is bright and that for parenteral agents may be limited.
Current prevention regimens are difficult for patients because of the need for injectable drugs, usually either fondaparinux (Arixtra), enoxaparin (Lovenox), dalteparin (Fragmin), or heparin.  Patients certainly prefer an oral drug, and the injections are safe but not completely without adverse effects, and administration costs are significant when injections are given by healthcare personnel.
Treatment regimens are even more difficult, costly, and labor-intensive.  The same injectable drugs are used, albeit for as many as 5-7 days in most instances, until warfarin (Coumadin) is "loaded" into the bloodstream.
Finally, and perhaps most importantly, replacing warfarin with a more predictable drug, with fewer drug interactions, no further need for blood test monitoring, and a similarly low risk profile, remains the Holy Grail of anticoagulation therapy.  An entire cottage industry has grown up around educating patients about warfarin effects, monitoring, and dietary restrictions, and simpler methods for obtaining these repeated blood specimens.
Dabigatran appears to achieve these goals in somewhat limited data thus far.  The "RE-COVER" and "RE-MEDY" trials of dabigatran in treatment of established VTE will be exceedingly important for Boehringer-Ingelheim in demonstrating the success or failure of the drug in large numbers of patients with this diagnosis.
While other studies have been done on long-acting injectable drugs as an alternative to daily oral drugs, I think this concept will be less appealing to patients and to those of us treating VTE in large numbers of patients.  Oral is still so much preferred by patients, and we are all frightened by the prospect of trying to reverse the effect of a blood thinner and keep it reversed over the lengthy intervals while the drug clears from the patient's system.