CardioExchange Archive

September 1st, 2013

Is It Time to RE-ALIGN Our Thinking About Direct Thrombin Inhibitors?

Judith Andersen, AB, MD

Reflecting on the RE-ALIGN trial of dabigatran, Judith Andersen muses on the mechanisms of direct thrombin inhibitors.

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September 1st, 2013

Disappointing Results with Dabigatran for Mechanical Valves

Larry Husten, PHD

For more of our ESC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters. Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong […]

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April 30th, 2013

Anticoagulation Update: New Agent for Urgent Anticoagulation Reversal, Pradaxa Label Revised

Larry Husten, PHD

Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. The FDA yesterday approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Unlike plasma, which is currently the only available method to reverse […]

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April 4th, 2013

Registry Study Offers Reassurance About Safety and Efficacy of Dabigatran

Larry Husten, PHD

As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American […]

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March 13th, 2013

FDA Officials Calm Concerns Over Excessive Bleeding with Dabigatran

Larry Husten, PHD

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases of bleeding associated […]

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February 25th, 2013

Selections from Richard Lehman’s Literature Review: February 25th

Richard Lehman, BM, BCh, MRCGP

This week’s topics include extended use of apixaban, dabigatran, warfarin, or placebo in VTE, the 5-year follow-up of the SYNTAX study, and more.

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February 20th, 2013

New Studies Examine Prolonged Anticoagulation for VTE Recurrence

Larry Husten, PHD

Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). In the RE-MEDY and the RE-SONATE trials, the role of dabigatran was examined in patients who had completed at least 3 months […]

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January 17th, 2013

Revisiting Novel Anticoagulants in Atrial Fibrillation

John Ryan, MD and Christian Thomas Ruff, MD, MPH

Two experts discuss the evolving landscape of novel anticoagulants for patients with AF. Do you agree with their perspectives? What questions do you have? What has your experience taught you?

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December 21st, 2012

Dabigatran Shouldn’t Be Used in Patients with Mechanical Heart Valves

Kristin J. Kelley, CardioExchange Staff

Dabigatran (Pradaxa) should not be prescribed to prevent blood clots or stroke in patients with mechanical heart valves, the FDA warned. The warning follows the termination of a European clinical trial in which patients taking dabigatran had more frequent thromboembolic events than those on warfarin. Dabigatran patients also experienced more bleeding after valve surgery. Patients with mechanical […]

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December 19th, 2012

Pradaxa To Be Contraindicated in Patients with Mechanical Heart Valves

Larry Husten, PHD

Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that, […]

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