November 6th, 2014
Agent Could Potentially Reverse Anticoagulation Associated with Edoxaban
PER977 — a cation that binds to all of the new oral anticoagulants and heparin — may help reverse the anticoagulant effects of edoxaban, according to results of an industry-conducted trial published in the New England Journal of Medicine. Edoxaban, an oral factor Xa inhibitor, was recently recommended for approval by an FDA advisory panel. Researchers […]
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 […]
May 13th, 2014
FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa
Larry Husten, PHD
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 over 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared with […]
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), […]
March 17th, 2014
Selections from Richard Lehman’s Literature Review: March 17th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include a comparison of the safety and efficacy of the new oral anticoagulants with warfarin in patients with AF, a study on mortality from ruptured abdominal aortic aneurysms, and more.
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 […]
February 24th, 2014
What Is “Non-Valvular” Atrial Fibrillation?
Shengshou Hu, M.D.
Wes Fisher attempts to figure out what the latest marketing phrase – non-valvular atrial fibrillation – really means.
January 28th, 2014
Problems Persist Despite Gains in Oral Anticoagulant Use
Larry Husten, PHD
Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk for stroke. Many elderly patients are not receiving oral anticoagulants — either traditional warfarin or […]
November 19th, 2013
Another New Anticoagulant Works Well in AF Patients
Larry Husten, PHD
Edoxaban, a direct oral factor Xa inhibitor, 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. In the trial, more than 21,000 […]
September 1st, 2013
Positive Results for Edoxaban in VTE/PE
Larry Husten, PHD
Findings from the Hokusai-VTE trial of edoxaban