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Benefits of dabigatran against recurrent VTE maintained 1 year after drug discontinuation
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ATLANTA — Patients in the RE-SONATE trial who extended treatment with dabigatran etexilate during the double blind treatment period experienced reductions in risk for venous thromboembolism that were preserved during 1 year of follow-up after discontinuation of the study drug.
The RE-SONATE trial compared 6 months of dabigatran 150 mg twice daily (Pradaxa, Boehringer Ingelheim) vs. placebo among patients who needed additional oral anticoagulation following 6 to 18 months of vitamin K antagonist treatment.
In the overall trial, dabigatran was associated with a 92% relative risk reduction for recurrent symptomatic VTE vs. placebo. The drug also was associated with low risk for major bleeds.
Sam Schulman
Sam Schulman, MD, PhD, of the department of medicine at McMaster University, and colleagues presented results of an extended observational follow-up period of 1 year following completion of study treatment to assess VTE recurrence following discontinuation of study treatment. The extended follow-up population was a subset of the full analysis population.
During the initial double blind treatment period of up to 6 months, 0.4% of patients treated with dabigatran and 5.6% of patients treated with placebo experienced recurrent symptomatic VTE or unexplained death (HR=0.08; 95% CI, 0.02-0.25).
In addition, major bleeds were reported in two patients (0.39%) treated with dabigatran compared with no bleeds in patients treated with placebo. No unexplained deaths occurred in the dabigatran group compared with one in the placebo group.
The extended follow-up analysis included 1,323 patients.
Researchers presented data on the cumulative incidence of recurrent symptomatic VTE and unexplained death during the uncontrolled post-treatment follow-up period. The rates were 2% in the former dabigatran group vs. 5.7% in the former placebo group at 40 days (P=.0005); 6% vs. 10.2% at 6 months (P=.006); and 7.8% vs. 11.6% at 1 year (P=.0261). The absolute risk difference was 3.7% after 40 days, 4.3% after 6 months and 3.8% after 1 year of uncontrolled follow-up.
“The high rate of recurrent VTE, even in the former dabigatran group (7% to 8%), suggests that a longer duration of anticoagulant therapy may be warranted,” the researchers wrote.
For more information:
Schulman S. Abstract #21. Presented at: the 2012 ASH Annual Meeting and Exposition; Dec. 8-11, 2012; Atlanta.
Disclosure: Two researchers involved with the study report employment relationships with Boehringer Ingelheim.