Posts Tagged ‘dabigatran’

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October 7th, 2014

Another Reason for Open Access to Clinical Trial Data?

A correction to the RE-LY trial results, partly brought to light because of litigation, has Harlan Krumholz wondering if this is another example of why we should have open access to clinical trial data.


July 28th, 2014

Selections from Richard Lehman’s Literature Review: July 28th

This week’s topics include a comparison of catheter-directed thrombolysis plus anticoagulation and anticoagulation alone to treat DVT, several papers on dabigatran and bleeding risk, and more.


July 23rd, 2014

More Questions Raised About Dabigatran

Once again, dabigatran (Pradaxa) has raised the wrath of the critics. Several articles (see here, here, and here) and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The […]


May 13th, 2014

FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of over 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared with […]


April 7th, 2014

Dabigatran Approved for Treatment of DVT and PE

Boehringer Ingelheim announced on Monday that the FDA has approved dabigatran (Pradaxa) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. All three of the new oral anticoagulants — dabigatran, rivaroxaban (Xarelto), […]


January 3rd, 2014

FDA Plans New Safety Assessment of Dabigatran (Pradaxa)

Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. On December 30 the FDA posted a request for public comment on a proposed […]


December 18th, 2013

New Trial Confirms Role for Dabigatran in Venous Thromboembolism

A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for […]


December 5th, 2013

Large Study Finds Favorable Risk-Benefit Profile for the New Anticoagulants

A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of […]


November 4th, 2013

Should Plasma Levels of Dabigatran Guide How We Dose the Drug?

Stuart J. Connolly discusses his research group’s analysis of data from the RE-LY trial, concerning the relationship between plasma concentrations of dabigatran and the risks for ischemic events and major bleeding.


September 30th, 2013

Selections from Richard Lehman’s Literature Review: September 30th

This week’s topics include the RE-ALIGN trial of dabigatran vs. warfarin in patients with mechanical heart valves, general population echo screening and long-term survival, and antihypertensives and breast cancer risk among middle aged women.