Boehringer Ingelheim study to assess safety and effectiveness of oral anticoagulants

RIDGEFIELD, Conn. — Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital on a long-term study program to assess comparative effectiveness and safety, as well as prescribing patterns, of oral anticoagulants, including Pradaxa, for the reduction of stroke risk in U.S. patients with non-valvular atrial fibrillation. Brigham and Women's Hospital is an internationally recognized teaching affiliate of Harvard Medical School known for its excellence in patient care, medical research and training of outstanding young health professionals.

The objective of the study program is to better understand the real-world safety and effectiveness of warfarin and newer oral anticoagulants, including Pradaxa. Brigham and Women's Hospital will analyze claims data from UnitedHealth Group's research database, which is managed by one of the largest healthcare companies in the United States, serving more than 80 million individuals worldwide.

"It is our hope that the results of this study program will improve awareness that stroke risk related to NVAF is a growing public health issue and increase understanding of real-world experiences with new oral anticoagulants on the market to reduce stroke risk," said Sebastian Schneeweiss, vice chief, division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women's Hospital, and professor of medicine and epidemiology, Harvard Medical School. "This research will allow us to produce additional data over several years that will help the medical community and patients understand the risks and benefits of anticoagulants used to reduce the risk of stroke associated with non-valvular atrial fibrillation."

The study program demonstrates the commitment of Boehringer Ingelheim and Brigham and Women's Hospital to research that analyzes real-world data to help enhance patient health and ensure patients with NVAF have additional information about treatments available to help reduce the risk of debilitating and potentially fatal strokes, the company stated. In addition to this study program, Boehringer Ingelheim launched the Gloriatm-AF registry program in April 2012, a worldwide registry with the aim of understanding the long-term use of OAC therapy in the reduction of NVAF-related stroke-risk in a real-world setting.

"Our support of the study program being conducted by Brigham and Women's Hospital is a sign of our shared commitment to help improve healthcare delivery and outcomes for the estimated five million patients with non-valvular atrial fibrillation in the U.S. who are at increased risk for stroke," said Sabine Luik, M.D., senior vice president, medicine and regulatory affairs, U.S. regional medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "As a science-based company, Boehringer Ingelheim considers patient safety and education as top priorities, and we remain dedicated to research and education which fosters greater public health."


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