March 30th, 2011
Champaign, IL

Dr. Abraham Kocheril was an investigator in the trial which led to drug’s FDA approval

The US FDA recently approved dabigatran (Pradaxa) for the prevention of stroke and systemic embolism in patients with atrial fibrillation, a heart rhythm disorder which is a leading risk of stroke in the US. It may be used in patients who have already had a stroke as well. 

While a Professor of Medicine and Director of Clinical Electrophysiology at the University of Illinois in Chicago, Christie Clinic’s Cardiac Electrophysiologist, Dr. Abraham G. Kocheril, was an investigator in the RE-LY trial, which led to the drug’s FDA approval.  The large 18,000-patient Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY) study showed dabigatran to be superior in reducing strokes and reducing intracranial bleeding compared to warfarin (the standard blood thinner, approved in 1954).

Quality of Life for Patients

FDA reviewers thought the data strongly supports the 150-mg dose, noting that it was superior to warfarin on the primary end point and similar in terms of bleeding rates. This medication can significantly improve the quality of life for patients since it does not require frequent blood testing.  There is also less interaction with other medications and less need for dietary restrictions.

Side Effects

As with other approved anticlotting drugs, bleeds were among the most common adverse reactions reported by patients treated with dabigatran in studies.  Other side effects, including gastrointestinal symptoms, dyspepsia, stomach pain, nausea, heartburn, and bloating also were reported.

Links

• Dr. Abe Kocheril Interviewed on Stroke Prevention Medicine

Tags: cardiology, abe kocheril, cardiac electrophysiologist, stroke, dabigatran, fda