FDA study shows dabigatran lowers stroke risk

In a new FDA study of more than 134,000 Medicare patients, new users of dabigatran (Pradaxa) had a lower risk of clot-related strokes, bleeding in the brain, and death than those taking warfarin. However, dabigatran was associated with a higher risk of major gastrointestinal bleeding than warfarin, according to the FDA’s drug safety communication.

Dabigatran and warfarin are indicated for the treatment of patients with non-valvular atrial fibrillation who are at risk for stroke and blood clots. Both drugs in the new FDA study were shown to have a similar risk of myocardial infarction (MI), FDA stated.

“Importantly, the new study is based on a much larger and older patient population than those in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern,” the report said.

“The study findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval,” FDA said.

FDA had reported in November 2012 that the agency had received many post-marketing reports of bleeding among patients taking dabigatran. The agency conducted a review of insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative of new users of dabigatran and warfarin and determined the rates of gastrointestinal bleeding and intracranial bleeding to be similar. FDA announced at that time it would continue to evaluate other data sources in this ongoing safety review of dabigatran.

“As a result of our latest findings,” FDA said, “we still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.”