Dabigatran's bleeding safety profile similar to warfarin

In a study comparing the management and prognosis of bleeding related to warfarin and dabigatran, managing bleeding was not any more difficult and the prognosis was not any worse with warfarin. While patients who experienced major bleeding while using dabigatran required more transfusions, they also had a shorter hospital stay and tended to have lower mortality than patients on warfarin. The results were published in the Oct. 1 issue of Circulation.

The authors, led by Ammar Majeed, MD, of the Karolinska Institute in Stockholm, Sweden, used pooled data from previous trials comparing the two drugs. One trial compared dabigatran (Pradaxa, Boehringer Ingelheim) with placebo. Independent investigators reviewed bleeding reports from more than 1,000 patients with 1,121 major bleeds. Boehringer Ingelheim provided funding for the study.

The analysis revealed that patients who experienced major bleeding on dabigatran were older, had a low creatinine clearance rate and used aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) more often than patients who took warfarin.

The 30-day post-bleed mortality rate was lower among dabigatran patients (9.1 percent vs. 13 percent). After multivariate adjustment, the odds ratio for dabigatran mortality was 0.66 compared with 0.68 with warfarin.

Blood transfusions were more common in the dabigatran group compared with patients taking warfarin, but they received less plasma. Dabigatran patients also had shorter stays in the intensive care unit (by about 1.6 days) than patients taking warfarin.

Because the study participants who used dabigatran were older, had poorer kidney function and were also using aspirin or NSAIDs, the authors argued that these patients were higher risk than patients taking warfarin and could benefit from a lower dose of dabigatran. Additionally, stopping aspirin and NSAIDs could also make bleeding less severe.

The findings, they continued, suggested that dabigatran-associated bleeding was not any more unsafe than bleeding related to warfarin.

“More frequent transfusion with red cells was counterbalanced by shorter stay by approximately one day in the intensive care unit and less frequent transfusion of plasma,” the authors wrote.