–But still unclear whether benefit justifies the cost. Because its effects can be highly variable, warfarin is a notoriously difficult drug to administer. In recent years warfarin has resulted in more medication-related visits to emergency departments among older patients than any other drug. Researchers have long hoped that genotype-guided dosing of warfarin might reduce the…
In Which I Go Under The Knife And Learn About Medicine In The Real World
January 27, 2017 by 7 Comments
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…
Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy
July 13, 2016 by Leave a Comment
–FDA says the manufacturer has not demonstrated that it has fixed the problem. The Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The…
AF Patients at Increased Risk for Silent Strokes
November 4, 2014 by Leave a Comment
The increased risk of stroke in people with atrial fibrillation (AF) is well known, and this stroke risk is, of course, linked to an increased risk of cognitive impairment and dementia. Less well known is that people with AF have an increased risk for cognitive impairment independent of their stroke risk. Now a new study published…
Study Finds Flaws in New Treatment For Blood Clots
July 22, 2014 by Leave a Comment
In recent years, catheter-directed thrombolysis (CDT) has been added to the current standard of anticoagulation therapy in some patients with deep vein thrombosis (DVT). The hope was that CDT would help reduce the high rate of post-thrombotic syndrome (PTS), but now an observational study finds no benefits and some important disadvantages associated with CDT. In a…
Mixed Results for Thrombolysis in Pulmonary Embolism
June 17, 2014 by Leave a Comment
The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation. A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients. Overall, there…
Warfarin Benefits Extended To Patients with Chronic Kidney Disease
March 4, 2014 by Leave a Comment
Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD….
FDA Once Again Rejects New Indication For Rivaroxaban
February 14, 2014 by Leave a Comment
The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in…
FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)
March 4, 2013 by Leave a Comment
For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS). … In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS…
New Studies Examine Prolonged Anticoagulation For VTE Recurrence
February 20, 2013 by Leave a Comment
Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). … In an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is…
Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients
December 12, 2012 by 2 Comments
Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board The RE-ALIGN trial was an open-label,…
Prolonged Anticoagulation With Apixaban Found Beneficial In Venous Thromboembolism
December 8, 2012 by Leave a Comment
A new study suggests that extending anticoagulant therapy for an additional year may be beneficial after patients with venous thromboembolism complete their initial course of therapy. The results of AMPLIFY-EXT (Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment) were presented at the annual meeting of the American…
Longer Warfarin Therapy After Bioprosthetic Aortic Valve Replacement May Be Beneficial
November 27, 2012 by Leave a Comment
Three months of warfarin is the usual standard of care following bioprosthetic aortic valve replacement (AVR), although the supporting evidence base for this practice is limited. Now a large new registry study published in JAMA suggests that more prolonged warfarin therapy may be beneficial. Danish researchers identified 4,075 patients who underwent bioprosthetic AVR. As expected,…
Setback For Trial Studying Dabigatran After Mechanical Valve Surgery
October 23, 2012 by 2 Comments
Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…
High Rate Of Warfarin Discontinuation Observed In Study
October 22, 2012 by Leave a Comment
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…
Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation
September 21, 2012 by 2 Comments
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation (AF). The drug is already approved in Europe for the prevention of venous thromboembolic events (VTE) following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here…
FDA Rejects ACS Indication for Rivaroxaban (Xarelto)
June 21, 2012 by 2 Comments
The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on…
WARCEF: No Advantage For Warfarin Over Aspirin In Heart Failure
May 3, 2012 by 1 Comment
A new study offers “no compelling reason” to use warfarin instead of aspirin in heart failure patients who don’t have atrial fibrillation. In a paper published in the New England Journal of Medicine, Shunichi Homma and members of the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) study group report the results of a trial…
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
February 28, 2012 by Leave a Comment
The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk of cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months…
Study Explores Role of Periprocedural Dabigatran in AF Ablation
February 2, 2012 by 1 Comment
Updated with a comment from John Mandrola– As dabigatran becomes more widely used in atrial fibrillation (AF) patients, electrophysiologists are now trying to figure out how to handle anticoagulation in patients taking dabigatran (Pradaxa) for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues…
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