Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield has completed enrollment and has begun its trial for randomized evaluation of long-term anticoagulant therapy, RE-LY, to evaluate the effectiveness and safety of an experimental oral anticoagulant, dabigatran etexilate.
The medicine is supposed to prevent systemic embolism and clotting and therefore strokes.
Boehringer Ingelheim”™s RE-LY is reportedly the leader in stroke-prevention trials conducted to date. There have been 18,114 patients, in 1,000 centers in 44 countries worldwide, enrolled between December 2005 and December 2007. Presently, more than 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.
“Our investment in landmark trials such as RE-LY demonstrates Boehringer Ingelheim”™s ongoing commitment to improving future treatment options for patients with cardiovascular conditions,” said Dr. Andreas Barner, member of the board at Boehringer Ingelheim.
The trial compares two blinded doses of oral dabigatran etexilate with sodium based warfarin, the current preferred blood clot inhibitor. The patients in the trial are at moderate-to-high risk of stroke. The current standard treatment to prevent stroke in these patients, the vitamin K antagonist warfarin, is currently prescribed for only half of all eligible patients.
“Patient enrollment in RE-LY has exceeded our original expectations by far,” said Dr. Salim Yusuf, professor of epidemiology and cardiology and head of the study coordinating center at McMaster University in Hamilton, Ontario.
According to the American Heart Association, atrial fibrillation is a disorder found in about 2.2 million Americans. About 15 percent of strokes occur in people with atrial fibrillation.
The likelihood of developing atrial fibrillation increases with age. Three to 5 percent of people over 65 have atrial fibrillation and up to 10 percent of people over 80.
Atrial fibrillation is a leading risk factor for stroke and, despite warfarin being available as an effective treatment option, atrial fibrillation still accounts for approximately 15 percent of all strokes.
Approximately 750,000 Americans suffer a stroke each year with upwards of 150,000 being fatal, making it the third leading cause of death in the United States.
Strokes are also the leading cause of chronic adult disability in the United States and the primary reason why people end up in assisted-living homes. Stroke is associated with a heavy cost burden: treating and preventing stroke costs the U.S. healthcare system almost $63 billion each year.
The results of clinical trials evaluating the use of dabigatran etexilate in the prevention of venous thromboembolism have already been published and an application for registration in Europe was submitted in February 2007.
