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Long-Term Data Support Safety Profile of Dabigatran (Pradaxa) for Stroke Prevention

Major bleeding rate less than 4% per year in extension trial (June 14)

Positive safety results have been reported from the RELY-ABLE trial, a long-term extension of the pivotal RE-LY study of dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) capsules in patients with non-valvular atrial fibrillation (NVAF).

The RELY-ABLE study was designed to evaluate the long-term safety of ongoing dabigatran therapy in patients with NVAF following the RE-LY trial. Accordingly, patients enrolled in RELY-ABLE continued dabigatran therapy, as dosed in RE-LY, for an additional 2.3 years, bringing the mean duration of treatment to 4.3 years. A total of 5,851 patients participated in the extension study: 2,937 received dabigatran 150 mg twice daily, and 2,914 received dabigatran 110 mg twice daily.

Rates of major bleeding, the study’s primary endpoint, were 3.74% (n = 238) per year with dabigatran 150 mg and 2.99% (n = 190) per year with dabigatran 110 mg (hazard ratio [HR], 1.26). Major gastrointestinal bleeding occurred at rates of 1.54% (n = 98) per year with dabigatran 150 mg and 1.56% (n = 99) per year with dabigatran 110 mg.

Additional findings include:

  • Rates of stroke or systemic embolism for dabigatran 150 mg and 110 mg were 1.46% (n = 93) and 1.60% (n = 102) per year, respectively (HR, 0.91).
  • Rates of ischemic stroke or unspecified stroke were 1.15% (n = 73) and 1.24% (n = 79) per year in the dabigatran 150 mg and 110 mg groups, respectively (HR, 0.92).
  • Rates of hemorrhagic stroke were similar in the two treatment arms: 0.13% (n = 8) and 0.14% (n = 9) per year for dabigatran 150 mg and 110 mg, respectively (HR, 0.89).
  • Rates of myocardial infarction were also low at 0.69% (n = 44) and 0.72% (n = 46) per year for dabigatran 150 mg and 110 mg, respectively (HR, 0.96).
  • Dyspeptic symptoms were reported in 5.3% (n = 156) and 4.8% (n = 141) of patients treated with dabigatran 150 mg and 110 mg, respectively.
  • The total mortality rates were 3.02% (n = 192) and 3.10% (n = 197) per year for dabigatran 150 mg and 110 mg, respectively (HR, 0.97).
  • Serious adverse events occurred in 36.3% (n = 1,067) and 33.7% (n = 982) of patients treated with dabigatran 150 mg and 110 mg, respectively.

Source: Boehringer Ingelheim; June 14, 2013.

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