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2 Studies Find Gastrointestinal Bleeding Risk From Pradaxa

2 Studies Find Gastrointestinal Bleeding Risk From Pradaxa

November 7, 2014 — The blood-thinning drug Pradaxa has been linked to higher rates of gastrointestinal bleeding compared to warfarin in two new massive studies of Medicare patients with irregular heart rhythm (atrial fibrillation).

One study, published in Circulation in October 30, involved data on over 134,000 Medicare patients.

Overall, results were reassuring. Patients on Pradaxa were less likely to have a stroke, bleeding in the brain, or die compared to patients on warfarin. Rates of heart attack and major bleeding were equivalent.

Pradaxa was associated with 28% more gastrointestinal bleeds. The increased risk is backed-up by data from the RE-LY clinical trial, which Boehringer Ingelheim used to convince the FDA to fast-track Pradaxa through the approval process in 2010.

The reassuring results were refuted in a study published this month by JAMA Internal Medicine, which looked at data on a 5% random sample of Medicare patients. Unlike previous studies, researchers adjusted for patient risk-factors that could skew the results.

The JAMA study linked Pradaxa with an 85% increased risk of gastrointestinal bleeding, a 58% increased risk of major bleeding, and a 30% overall increased risk of any bleeding compared to warfarin.

Although an FDA-funded study published earlier this year found no difference in the bleeding risks of warfarin versus Pradaxa, JAMA editor-in-chief Dr. Rita Redberg wrote in an accompanying editorial:

“The authors note the FDA [study] failed to adjust for differences in patient characteristics, which would bias the results. [The findings] give us cause for concern because it appears that the bleeding risk for dabigatran is higher than for warfarin and significantly greater than originally appeared at the time of the FDA approval.”

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