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Reinforced safety profile of Boehringer Ingelheim’s Pradaxa released

Tuesday, November 19, 2013

Boehringer Ingelheim Pharmaceuticals has announced results from a new, long-term, combined analysis of the pivotal phase III RE-LY trial and its extension safety study RELY-ABLE. The data showed that after a median follow up of 4.6 years, with some patients followed up to 6.7 years, rates of stroke/systemic embolism and major bleeding were consistent with rates in previously reported analyses of RE-LY, one of the largest stroke prevention clinical studies ever conducted in patients with non-valvular atrial fibrillation (NVAF).

“This is the first set of data to provide results after long-term continuous follow-up of more than four years in a large set of NVAF patients who were treated with one of the newer oral anticoagulants (OAC),” said Michael D. Ezekowitz, M.D., Ph.D., FACC, professor of medicine at Thomas Jefferson Medical College in Philadelphia. “Patients with NVAF need long-term treatment with anticoagulants in order to lower their risk of stroke, and these data are crucial in understanding PRADAXA’s long-term safety in patients with NVAF.”

Following the RE-LY trial, a total of 5,851 patients, who were randomized to either 110mg or 150mg twice daily (BID) of dabigatran, continued the same blinded dose of dabigatran in RELY-ABLE. Median follow up was 4.6 years, with a maximum 6.7 years total follow up (RE-LY plus RELY-ABLE). This new analysis showed that the rates of stroke or systemic embolism for dabigatran 150mg BID and 110mg BID were 1.25% and 1.54% per year, respectively.

The low rates of hemorrhagic stroke seen during RE-LY (approximately one case per thousand per year) were observed over the whole duration of follow-up. Mortality rates were similar for the two dabigatran doses: 3.43% per year for 150mg BID and 3.55% per year for 110mg BID; HR 0.97 (95% CI: 0.87-1.08). Additional results from the combined analysis of RE-LY and RELY-ABLE included: Rates of ischemic stroke for dabigatran 150mg BID and 110mg BID at 1.03% and 1.29% per year, respectively and rates of major hemorrhage for dabigatran 150mg BID and 110mg BID at 3.34% and 2.76% per year, respectively.

“We are pleased that these long-term results are consistent with our pivotal RE-LY data and support PRADAXA 150mg twice daily as an important treatment option in patients with NVAF when used as directed,” said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. regional medical director, Boehringer Ingelheim Pharmaceuticals.

PRADAXA was the first OAC approved by the FDA in more than 50 years to reduce the risk of stroke and systemic embolism in patients with NVAF. PRADAXA is the only OAC to be shown to be superior to warfarin in reducing ischemic stroke, a key consideration in anticoagulant therapy given that nearly nine out of 10 strokes caused by atrial fibrillation (AFib) are ischemic strokes. Since its discovery 20 years ago, PRADAXA has been evaluated through the extensive RE-VOLUTION clinical trial program, which includes 10 completed clinical trials involving approximately 40,000 patients in more than 44 countries.

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