CardioExchange Archive

September 6th, 2011

FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

Larry Husten, PHD

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 is […]

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August 30th, 2011

Is Warfarin Still the First Choice in Atrial Fibrillation?

Stephen Fleet, MD

There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last. A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran. Even Dr. Ezekowitz, the warfarin protagonist for purposes […]

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August 28th, 2011

ARISTOTLE Finds the Golden Mean of Anticoagulation

Larry Husten, PHD

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 Stroke and Other […]

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August 10th, 2011

Rivaroxaban Compared with Warfarin in 14,000 AF Patients

Larry Husten, PHD

In ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), researchers tested rivaroxaban (20 mg/day) against warfarin in 14,264 patients with nonvalvular atrial fibrillation (AF). The results of the trial, which were first presented last November at the American […]

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July 14th, 2011

Rivaroxaban: The Next Non-Warfarin Oral Blood Thinner

John Mandrola, MD, FACC

An electrophysiologist and blogger places the recent approval of rivaroxaban in the context of the seismic changes that have taken place and that are still expected in the anticoagulant marketplace.

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July 1st, 2011

Rivaroxaban (Xarelto) Gains First FDA Approval for DVT Prevention

Larry Husten, PHD

Rivaroxaban (Xarelto, Janssen) received FDA approval today for the prevention of deep-vein thrombosis in patients undergoing knee or hip replacement surgery. This oral anticoagulant has been approved for use at a 10-mg dose, once daily, for 35 days following hip replacement and for 12 days following knee replacement surgery. The company has also submitted an application […]

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April 5th, 2011

MAGELLAN: Higher Bleeding Rates Cloud Rivaroxaban’s Effect in VTE Prevention in Acutely Ill Medical Patients

Larry Husten, PHD

The novel anticoagulant rivaroxaban is successful in preventing venous thromboembolism (VTE) in acutely ill medical patients, but a high bleeding rate means the drug probably won’t be used for this indication. Alexander Cohen, presenting the results of the MAGELLAN trial at the ACC in New Orleans, explained by way of background that 50% to 70% […]

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December 4th, 2010

Rivaroxaban Found Safe and Effective for DVT

Larry Husten, PHD

In the EINSTEIN-DVT noninferiority study, 3449 patients with acute DVT were randomized to receive open label oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months. The rate of recurrent VTE, the primary efficacy outcome, was lower with rivaroxaban treatment than with enoxaparin treatment, successfully demonstrating noninferiority for […]

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November 1st, 2010

ROCKET AF: Is Rivaroxaban Ready for Blast Off?

Harlan M. Krumholz, MD, SM

With the approval of dabigatran and now the preliminary and partial results of ROCKET AF, we’ll  need to be familiar with much more than just warfarin to address the anticoagulation needs of our patients. The early word on ROCKET AF, which will be presented at AHA, is that rivaroxaban is at least as effective as warfarin […]

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November 1st, 2010

Rivaroxaban Equals Warfarin in ROCKET AF

Larry Husten, PHD

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  trial’s scheduled presentation at the AHA on November 15. ROCKET AF randomized more than 14,000 patients with nonvalvular AF to either rivaroxaban or warfarin. The goal of the […]

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