Boehringer Ingelheim has taken the voluntary decision to discontinue treatment with the oral anticoagulant Dabigatran etexilate ( Pradaxa ) in a phase II clinical trial in patients with artificial heart valves. The company based its decision on interim results from RE-ALIGN trial which suggested that the investigated dosing regimen did not achieve the desired results in this patient population.
Dabigatran etexilate is not approved and not recommended for use in patients with prosthetic heart valves. The presence of an artificial heart valve in patients is a clinical condition that is distinct from those for which Dabigatran is an approved treatment. In view of the interim trial results, the company is currently in discussions with the relevant regulatory authorities to reinforce the product label text accordingly and to discuss appropriate communication to physicians and relevant health care providers.
Dabigatran etexilate is an oral anticoagulants/direct thrombin inhibitors ( DTIs ) in the prevention and treatment of acute and chronic thromboembolic diseases. Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin ( both free and clot-bound ), the central enzyme in the process responsible for thrombus formation.
In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.
The clinical trial programme to evaluate the efficacy and safety of Dabigatran etexilate encompasses studies in: primary prevention of venous thromboembolism ( VTE ) in patients undergoing elective total hip and knee replacement surgery, treatment of acute VTE, secondary prevention of VTE, stroke prevention in atrial fibrillation, prevention of thromboembolism after heart valve replacement.
Source: Boehringer Ingelheim, 2012