(RxWiki News) Blood thinner dabigatran (Pradaxa), approved in 2010 to prevent stroke in patients with atrial fibrillation, a common heart arrhythmia, is linked to an increased risk of heart attack, a new trial suggests.
The original trial RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) examined the drug as compared to warfarin, long the standard of care for atrial fibrillation patients.
It suggested a small increased risk of heart attack. Atrial fibrillation patients are at an increased risk of blood clots, which could lead to a potentially fatal stroke.
"Speak to your doctor about risks associated with Pradaxa."
Ken Uchino, MD, a Cleveland Clinic neurologist and lead author of the study, and his team of researchers found that Pradaxa increased the risk of heart attack or acute coronary syndrome by 33 percent.
During the study investigators reviewed seven randomized controlled trials of Pradaxa that included reports of heart attack or acute coronary syndrome. More than 30,000 patients were included in the study, and the results were compared to patients taking warfarin or a placebo.
About 1.19 percent of patients taking Pradaxa experienced a heart event as compared to 0.79 percent of those in the control group.
Researchers concluded that while Pradaxa increased the risk of heart attack or acute coronary syndrome, it did not outweigh the benefits it provided in reducing the risk of stroke.
Separately, U.S. Food and Drug Administration officials currently are reviewing Pradaxa based on reports of serious bleeding events.
The review study was published in the Archives of Internal Medicine.