Search Results for: dabigatran

When You’re Hot You’re Hot: Salim Yusuf Second Most Influential Scientist in 2011

McMaster University’s Salim Yusuf has tied for second place in the annual ranking of the “hottest” scientific researchers, according to Thomson Reuter’s Science Watch.  Yusuf was a co-author of 13 of the most cited papers in 2011. Only one other researcher, genomic pioneer Eric Lander of the Broad Institute of MIT, had more highly-cited papers than Yusuf. Two of…

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Michael Ezekowitz Joining Cardiovascular Research Foundation To Establish AFib Research Center

Correction: An earlier version of this article erroneously stated that Ezekowitz would be leaving Lankenau.  Michael Ezekowitz is  joining the Cardiovascular Research Foundation (CRF) in New York City to start a new center for atrial fibrillation research. Ezekowitz, a cardiologist at the Lankenau Institute for Medical Research in Philadelphia, had been a professor and vice president for clinical research at…

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Guest Post: Industry Sponsored Editorial Assistance

Editor’s Note: The following guest post by Tom Yates is reprinted with permission from his blog Sick Populations. Yates is a UK-based physician with an interest in epidemiology and population health. Industry Sponsored Editorial Assistance by Tom Yates The September 2011 edition of the Quarterly Journal of Medicine contained two review articles which dealt with the use…

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Apixaban Gains Priority FDA Review for Stroke and VTE Prevention in AF

Bristol-Myers Squibb and Pfizer announced today that the FDA will give a priority-review to the new drug application (NDA) for apixaban (Eliquis) for the prevention of stroke and systemic embolism in AF patients. The FDA said a decision would be reached by March 28, 2012. The NDA is based on results from the large phase…

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Rivaroxaban Roundup: NEJM Perspective on FDA Panel, ATLAS-ACS Will Be an AHA Late-Breaker

Rivaroxaban (Xarelto, Bayer and Johnson & Johnson) is in the news today. In a rare move, the AHA has added the ATLAS ACS 2-TIMI 51 trial to its roster of Late-Breaking Clinical Trials to be presented next month at the AHA’s Scientific Sessions in Orlando. C. Michael Gibson will present the results on Sunday, November 13 at 5:13 PM….

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Live Blog– FDA Advisory Panel on Rivaroxaban (Xarelto)

Click here for a brief summary and commentary on the FDA panel hearing. Panel Adjourns! Good night everyone. 4:58– Lincoff asks if anyone thinks the transitioning study should be done pre-approval? Everyone seems ok with a post-marketing study. 4:55– Nissen wants to see the drug tested in a BID regimen. Papdemetriou wants a post-marketing study on transitioning….

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FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers…

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ARISTOTLE Study Finds the Golden Mean of Anticoagulation

In ancient Greece the philosopher Aristotle thought the golden mean was the desirable middle between two extremes, one of excess and the other of deficiency. In cardiology, apixaban may be the golden mean of anticoagulation, achieving the ideal balance of reduced strokes and deaths without causing any additional bleeding complications. The Apixaban for Reduction in…

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Guest Post: When Patients Can’t Afford a Medication

Editor’s Note: The following guest post by Beth Waldron is reprinted with permission from ClotConnect, a valuable resource for patients about blood clots and clotting disorders. Waldron is the program director of the UNC-Chapel Hill Blood Clot Outreach Program. Prescription Assistance: When Patients Can’t Afford a Medication Beth Waldron, Program Director of the Clot Connect project, writes…. Approximately 1…

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Rivaroxaban (Xarelto) Compared to Warfarin in AF Patients

The ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) trial tested rivaroxaban (20 mg/day) against warfarin in 14,264 patients with atrial fibrillation (AF).  The results of the trial, which were first presented last November at the American Heart Association, have now been…

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ESC Congress in Paris: Hot Lines and Clinical Trial Updates

Here are the Hot Line sessions and Clinical Trial Updates scheduled for the ESC Congress 2011 in Paris:…

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Pundits Declare Victory in Anticoagulant Contest But It’s Not Over Yet

The pundits and analysts have called it: apixaban (Eliquis), the oral, direct factor Xa inhibitor being jointly developed by BMS and Pfizer, is the winner. Dabigatran (Pradaxa) and rivaroxaban (Xarelto) will fight for the remainder of the market. Yesterday’s announcement of the topline results from ARISTOTLE indicates a clear victory for the drug, say the experts….

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Apixaban (Eliquis) Meets Primary Endpoint in ARISTOTLE

Pfizer and Bristol-Myers Squibb said today that their new oral direct Factor Xa drug apixaban, which will be marketed under the brand name of Eliquis, had met the primary endpoint of the ARISTOTLE study. The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) study was designed to compare the factor Xa inhibitor…

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PARTNER B Substudy Examines Cost Effectiveness of TAVR

Transcatheter aortic valve replacement (TAVR) is about as cost effective as other common cardiovascular procedures, according to results of the PARTNER B cost-effectiveness substudy, which were presented today at the American College of Cardiology meeting in New Orleans. (The main results of PARTNER B, which studied the safety and efficacy of TAVR in patients with…

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APPRAISE-2 Apixaban in ACS Study Discontinued Due to Increased Bleeding

Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2), a phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the Data Monitoring Committee based on “a clinically important increase in bleeding among patients…

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Bayer says rivaroxaban meets primary endpoint in ROCKET AF

Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the scheduled presentation of the trial at the AHA on November 15….

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ADVANCE-2 apixaban study published in Lancet

The ADVANCE-2 study, which was initially presented last summer at the ISTH meeting in Boston, has now been published in the Lancet. The trial randomized 3057 patients undergoing knee replacement surgery for thormboprophylaxis with either apixaban (2.5 mg daily) or subcutaneous enoxaparin (40 mg once daily). The primary composite endpoint, consisting of asymptomatic and symptomatic…

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EINSTEIN at ASH: rivaroxaban (Xarelto) prevents recurrent VTE, but bleeding may be a concern

EINSTEIN-Extension, which will be presented as a late-breaking clinical trial at the American Society of Hematology meeting in New Orleans on December 8, demonstrates that rivaroxaban (Xarelto), the direct oral factor Xa inhibitor, is effective in the long-term prevention of recurrent venous thromboembolism. But a high bleeding rate may dampen enthusiasm for the new oral anticoagulant….

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Play the CME Game at home or at the AHA

Like everyone else who is registered for the AHA meeting that starts in less than a week, my mailbox has been overflowing for the past month of so with invitations for satellite programs taking place in Orlando. Normally I throw these out but for some reason this year I didn’t, and I watched in amazement…

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Extreme cardiology culture: Califf, Harrington, Topol & Teirstein

Two new audio programs posted recently on TheHeart.Org provide a fascinating snapshot of the extremes of contemporary cardiology….

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Barcelona: List of ESC Hot Lines, Clinical Trial Updates, and Science Hot Lines

Updated and Corrected: The ESC has posted the complete scientific program for the ESC Congress 2009 in Barcelona. Here are the details for Hot Line, Clinical Trial Update, and Science Hot line  sessions. You can access the complete program at this link….

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Editorial: The Incompetence Of The FDA

As a journalist and editor who’s covered the cardiovascular arena for more than 25 years I’ve tried as much as possible to avoid taking positions on the major controvesies that have appeared over the years. I’m proud that during the “TPA wars” I remained on good terms with not only Eric Topol, Rob Califf and…

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