NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.
As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective
and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment
beyond three months to prevent recurrent venous thromboembolism."
In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these
patients need extended anticoagulation therapy beyond three months."
To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.
At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.
Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%
in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.
Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."
Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."
Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."
This study was funded by Daiichi-Sankyo. Dr. Raskob received fees from the company during the study. Other coauthors
also have ties to the company and a number are employees of Daiichi-Sankyo.