CardioExchange Archive

January 9th, 2015

FDA Approves New Oral Anticoagulant from Daiichi Sankyo

Larry Husten, PHD

And then there were four. Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace: dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis). All four drugs were […]

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August 21st, 2014

FDA Grants Apixaban Expanded Indication for Venous Thromboembolism

Larry Husten, PHD

The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new […]

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April 7th, 2014

Dabigatran Approved for Treatment of DVT and PE

Larry Husten, PHD

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), […]

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March 14th, 2014

Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery

Larry Husten, PHD

The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have […]

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December 18th, 2013

New Trial Confirms Role for Dabigatran in Venous Thromboembolism

Larry Husten, PHD

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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February 8th, 2013

Xarelto Effective in Medically Ill Patients, But at High Bleeding Cost

Larry Husten, PHD

The recent arrival of novel oral anticoagulants has provided important new options for treating and preventing venous thromboembolism (VTE). New indications for these drugs have been granted for patients with atrial fibrillation and for patients who have undergone orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not […]

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December 12th, 2012

AMPLIFYING Treatment for DVT/PE

John Ryan, MD

John Ryan reviews the latest data and suggests that DVT/PE be managed as a chronic condition. Are you using apixaban in these patients, and how long are you treating them for?

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November 3rd, 2012

Rivaroxaban Gains FDA Indications for Treating and Preventing DVT and PE

Larry Husten, PHD

The FDA has expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk for recurrent DVT and PE. The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE  after hip- and knee-replacement surgery and to reduce […]

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March 22nd, 2011

AHA Releases New Recommendations for Management of Acute VTE

Larry Husten, PHD

The AHA is offering new guidance for the management of patients with pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension. The scientific statement is published online in Circulation. In addition to advice about anticoagulant therapy, the statement offers extensive recommendations about the appropriate use of fibrinolytic agents, catheter-based and surgical interventions, and […]

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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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