Search Results for: dabigatran

ESC: Superiority of dabigatran more evident in places where INR is not well controlled

At last year’s ESC the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran. In a presentation at the…

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FDA sets September 20 date for dabigatran (Pradaxa) advisory panel

The FDA has announced that dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in atrial fibrillation will be the subject of a Cardiovascular and Renal Drugs ADvisory Committee on September 20. (h/t to Larry Biegelsen)…

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Genes, stem cells, ticagrelor, and dabigatran among AHA’s top 10 for 2009

The AHA today released its list of the top 10 advances in research in 2009. Here are the titles of the papers:…

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RE-COVER at ASH: Dabigatran equals warfarin for VTE treatment

Dabigatran (Pradaxa) is as effective as warfarin for the treatment of VTE, according to results of the RE-COVER study presented today at the American Society of Hematology meeting today and published online in the New England Journal of Medicine. Sam Schulman and colleagues randomized 2539 patients with acute VTE to warfarin or dabigatran (150 mg…

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RE-LY at ESC: dabigatran in, warfarin (finally) on the way out?

Is the long, unhappy reign of warfarin possibly drawing to a close? The RE-LY trial may have finally identified a candidate, dabigatran, an oral direct thrombin inhibitor that could one day replace warfarin. Unlike warfarin, dabigatran does not require dose adjustments or anticoagulation monitoring. RE-LY randomized 18,113 AF patients to either one of two fixed…

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If You Look For Atrial Fibrillation You Will Find Atrial Fibrillation

If you look hard to find people who have atrial fibrillation (AF) you will in fact find people who have atrial fibrillation, a new paper published in JAMA shows. But the paper offers no evidence whatsoever that the new diagnosis improves outcomes in these people, though it does find that the diagnosis leads to increased use of…

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In Which I Go Under The Knife And Learn About Medicine In The Real World

I’m not a doctor but I thought I knew something about anticoagulation. Over the course of a career covering cardiology I’ve written countless stories about heparin, warfarin, the low molecular weight heparins, and the new oral anticoagulants. So when I had bilateral total knee replacement a few weeks ago I thought I knew what to…

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Eliquis Nipping At The Heels of NOAC Market Leader Xarelto

–But the overall market for the new oral anticoagulants continues to expand. The new oral anticoagulant (NOAC) market is growing larger and is becoming increasingly competitive. The latest market data shows that apixaban (Eliquis, Pfizer and BristolMyers Squibb) is challenging the established leader in the field, rivaroxaban (Xarelto, Johnson & Johnson). According to recent data…

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More Bleeding Linked To Rivaroxaban In Observational Study

–Compared to dabigatran, rivaroxaban was associated with more intracranial and other serious bleeds. A new observational study finds that patients who take rivaroxaban (Xarelto, Johnson & Johnson) may be more likely to have serious bleeding events than patients who take dabigatran (Pradaxa, Boehringer Ingelheim). In a paper published in JAMA Internal Medicine, David Graham and…

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FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants

  Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…

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New Concerns Raised About Bioprosthetic Aortic Valves

New, potentially important concerns have been raised about bioprosthetic aortic valves, both those  implanted during surgery and those during a catheter-based procedure (TAVR). Investigators from three separate groups reported on their troubling findings in a paper published in the New England Journal of Medicine. The article was accompanied by both an editorial and a perspective from the FDA….

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More Questions Raised About Boehringer Ingelheim’s Pradaxa

Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles 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 BMJ, casts doubt on the reliability…

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Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million

Boehringer Ingelheim said today that it will pay $650 million in a “comprehensive settlement” of lawsuits over Pradaxa (dabigatran), the company’s novel anticoagulant. The company said that it expects the settlement will resolve about 4,000 current cases against the company in the US. … Click here to read the full post on Forbes.  …

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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 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared to warfarin….

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Boehringer Ingelheim’s Pradaxa Gains New Indication

The new oral anticoagulants continue to gain additional indications from the FDA. Earlier today Boehringer Ingelheim announced that the FDA had approved Pradaxa (dabigatran) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE). …  Click here to read the full post on Forbes.    …

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New Trial Confirms Role For Pradaxa 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…

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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…

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New Anticoagulant From Daiichi Sankyo Works Well In AF Patients

Edoxaban, a direct oral factor Xa inhibitor under development by Daiichi Sankyo, is the latest in the series of new oral anticoagulants seeking to take over the troubled role of warfarin in clinical practice. The results of ENGAGE-AF-TIMI 48 were presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine. The results of the trial were…

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

Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation.  … Pradaxa label gains boxed warning. …   Click here to read the full story on Forbes.    …

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Two Experts Help Sort Out The New Generation Of Anticoagulants

Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts. Christian Thomas Ruff: I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients…

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FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF

The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest…

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2012 In Review: A Bad Year For Conventional Wisdom

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…

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Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves

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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ASPIRE: Aspirin An Attractive Alternative After First VTE

It is unclear what the best approach is for the long-term treatment of people who have had a first unprovoked episode of venous thromboembolism (VTE). Although warfarin is effective at preventing a recurrence, it is inconvenient and raises the risk for bleeding. Newer anticoagulants have not been tested or approved for this population. The ASPIRE…

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High Rate Of Warfarin Discontinuation Observed In Study

One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now a new observational study published in Archives of Internal Medicine raises the possibility that the problem may be even worse than many may have previously suspected, as discontinuation rates in clinical…

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