Dabigatran users face increased risks for myocardial infarction and acute coronary syndrome (ACS) relative to those on control medications or placebo, according to a meta-analysis in the Archives of Internal Medicine.

Researchers examined outcomes in some 30,000 patients from seven randomized trials of dabigatran use in various settings (e.g., stroke prophylaxis, postsurgical prophylaxis of deep venous thrombosis). Overall, dabigatran was associated with significantly higher risks than control treatment; the risks remained elevated even when short-term studies were excluded. The increase in relative risk for MI or ACS was 33%, but the authors point out that the increase in absolute risk was modest, at 0.27%.

Commentators call the results “robust” and “alarming.” A separate editorial note says the findings “deserve serious consideration” when deciding whether to use dabigatran. Both commentaries say the study emphasizes the importance of continuing scrutiny after a drug’s approval.

Source:  Archives of Internal Medicine