Apixaban and Dabigatran Found Effective, Safe for Extended Venous Thromboembolism Therapy

In RE-MEDY, this outcome occurred in 1.8% of the dabigatran group and in 1.3% of the warfarin group, thus meeting the criteria for noninferiority to warfarin in preventing recurrent or fatal venous thromboembolism.

In RE-SONATE, this outcome occurred in 0.4% of the dabigatran group, compared with 5.6% of the placebo group, so the drug was significantly more effective than placebo at preventing recurrent or fatal venous thromboembolism.

Dabigatran was associated with markedly fewer major bleeding events (0.9% vs 1.8%) and clinically relevant bleeding events (5.6% vs 10.2%) than was warfarin. However, the drug was associated with more major or clinically relevant bleeding events than was placebo (5.3% vs 1.8%).

In addition, there was a higher rate of acute coronary events with dabigatran (0.9%) than with warfarin (0.2%), although the number of affected patients was small. A recent meta-analysis of seven noninferiority trials also showed a significantly higher risk of myocardial infarction or acute coronary syndromes with dabigatran than with the comparators. "Whether dabigatran increases the risk of myocardial infarction is therefore still unclear," Dr. Schulman and colleagues said.