New findings from two double-blind, randomized trials, RE-MEDYSM and RE-SONATE®, show that dabigatran 150 mg twice daily reduces the risk of recurrent venous thromboembolism (VTE). The results were published today in the New England Journal of Medicine.
VTE is the third most common cardiovascular disorder after heart disease and stroke, and consists of two related conditions caused by blood clots: deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is when a blood clot develops in the deep veins of the leg or pelvis. The clot, or part of it, can break off from the site where it formed and travel through the veins (embolism). A PE can occur if the clot lodges in the arteries of the lungs.
There are an estimated 900,000 VTE events per year in the U.S., approximately one-third of which result in death from PE. Further, roughly one-third of people with VTE will have a recurrence within 10 years. The standard of care for patients with VTE is anticoagulation.
RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. RE-SONATE demonstrated dabigatran was superior to placebo for the prevention of first recurrent or fatal VTE with a risk reduction of 92 percent during the treatment period (p<0.001). Lower event rates were reported across all secondary efficacy endpoints for dabigatran over placebo.
"Patients who suffer one VTE event are at increased risk of suffering another, with the risk accumulating over time," said Sam Schulman , M.D., Ph.D., FRCPC(C), lead study author and professor, Department of Medicine, McMaster University, Ontario, Canada. "We are encouraged to see that the RE-MEDY and RE-SONATE trials met their endpoints and we will continue to study the safety, efficacy and practical management of dabigatran."
In the RE-MEDY trial, there were fewer major bleeding events in patients with a prior history of VTE receiving dabigatran compared with those receiving warfarin. There was also a significantly lower risk (46 percent) of major or clinically relevant bleeding events in this same set of patients.
In the RE-SONATE trial, the incidence of major bleeding was two patients in the dabigatran group versus zero patients in the placebo group. Combined rates of major or clinically relevant bleeding were significantly higher in patients receiving dabigatran as compared with those receiving placebo.
"Boehringer Ingelheim is continuously searching for new and innovative ways to improve the lives of patients and build upon the breadth of clinical data for our existing products," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "RE-MEDY and RE-SONATE are the result of our commitment to address the complex medical need of patients with recurrent VTE, a potentially life-threatening condition."
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