You are here

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs