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24-10-2010 | Stroke | Article

FDA approves dabigatran for stroke prevention in AF


FDA website

MedWire News: The US Food and Drug Administration (FDA) has approved the direct thrombin inhibitor dabigatran to prevent stroke and embolism in patients with atrial fibrillation (AF).

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa [dabigatran]," commented Norman Stockbridge, from the FDA's Center for Drug Evaluation and Research.

The FDA's decision is based on the results of the RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) study, which included more than 18,000 AF patients who were randomly assigned to receive dabigatran or wafarin.

Patients given twice-daily dabigatran 150 mg had fewer strokes than those given warfarin, and had a similar number of bleeding events, while those given the 110 mg dose had a stroke rate comparable with those on warfarin but had fewer bleeding events.

The drug will be available as a 75-mg capsule for patients with severe renal impairment (creatinine clearance 15-30 ml/min) and as a 150-mg capsule for patients with normal kidney function.

Similar to warfarin, the drug label contains the warning that dabigatran can cause "serious and sometimes fatal" bleeding and physicians are advised to instruct their patients to contact healthcare services at the first sign of pathologic bleeding.

In RE-LY the annual major bleeding rates were 3.11% among patients taking dabigatran 150 mg and 3.36% among those taking warfarin. Dyspepsia was more frequent, at corresponding rates of 11.3% versus 5.8%, while rates of other side effects were similar in the two groups.

MedWire ( is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

By Eleanor McDermid

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