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Better Patient Outcomes With Dabigatran (Pradaxa) Versus Warfarin in Phase III Trials

Studies find trend toward lower mortality (October 2)

Positive results have been reported from a retrospective analysis that compared clinical management and patient outcomes after a major bleeding event during treatment with dabigatran (Pradaxa, Boehringer Ingelheim) or warfarin. The findings show that outcomes after a major bleed during treatment with dabigatran were not worse than after a warfarin-associated bleed, and may be better despite the lack of a specific reversal agent for dabigatran. The new findings were published in Circulation.

The pooled analysis consisted of data gathered from five phase III studies, including the pivotal RE-LY trial, which enrolled more than 18,000 patients with non-valvular atrial fibrillation (NVAF).

Key findings include the following:

  • Dabigatran 150 mg twice daily, compared with warfarin, was associated with significantly fewer intracranial hemorrhages (29 vs. 90 events, respectively; P P = 0.007), but significantly more gastrointestinal hemorrhages (218 vs. 151 events; P
  • In the RE-LY study, the length of stay in the intensive care unit after major bleeding events was shorter for dabigatran 150 mg twice daily than for wafrarin (1.9 vs. 2.7 nights, respectively; P = 0.10). The percent of patients hospitalized for a major bleeding event tended to be greater with dabigatran 150 mg twice daily than with warfarin (61.8% vs. 56.5%; P = 0.10), but the length of hospital stay was similar for both groups (8.5 vs. 8.9 days, P = 0.68).
  • The pooled odds ratio for death within 30 days after the first bleeding event, after adjusting for sex, age, weight, kidney function, and additional antithrombotic therapy, was reduced for dabigatran 150 mg twice daily compared with warfarin (0.68).

Pradaxa (dabigatran) is currently approved by the FDA to reduce the risk of stroke and systemic embolism in patients with NVAF and was the first oral anticoagulant approved in more than 50 years for this indication.

Source: PR Newswire; October 2, 2013.

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