–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…
FDA Reaffirms Safety And Efficacy Of Rivaroxaban
October 11, 2016 by Leave a Comment
–FDA says no changes needed to the rivaroxaban label. Following a year of controversy and uncertainty relating to the anticoagulant drug rivaroxaban (Xarelto, Johnson & Johnson), the FDA has reaffirmed the drug’s safety and efficacy. Rivaroxaban is approved for stroke reduction in patients with atrial fibrillation. The indication is based on results of the ROCKET-AF…
ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability
December 13, 2015 by Leave a Comment
(Updated) In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not…
New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf
November 30, 2015 by 1 Comment
(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…
Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding
November 10, 2015 by Leave a Comment
A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit…
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 Plans New Safety Assessment Of Dabigatran (Pradaxa)
January 3, 2014 by Leave a Comment
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. n December 30 the FDA posted a request for public comment on a…
Disappointing Results with Dabigatran for Mechanical Valves
September 1, 2013 by 1 Comment
Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been hoped that the newer generation of oral anticoagulants might eventually replace warfarin, making anticoagulation more tolerable and better accepted, since these agents don’t require continuous monitoring and have much fewer…
Encouraging 4 Year Results For Watchman Device In AF Patients
May 10, 2013 by Leave a Comment
Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver. Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events…
Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation
May 9, 2013 by 1 Comment
Many patients receiving an ICD or a pacemaker are already receiving oral anticoagulants. Current guidelines recommend replacement of the oral anticoagulant with the temporary use of heparin as a bridging strategy. Now a new study, BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial), offers convincing evidence that this strategy is not…
Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran
April 4, 2013 by Leave a Comment
As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American…
FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran
March 13, 2013 by 1 Comment
Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases…
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…
Two Experts Help Sort Out The New Generation Of Anticoagulants
January 17, 2013 by Leave a Comment
Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts. Christian Thomas Ruff: I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients…
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,…
ASPIRE: Aspirin An Attractive Alternative After First VTE
November 4, 2012 by Leave a Comment
It is unclear what the best approach is for the long-term treatment of people who have had a first unprovoked episode of venous thromboembolism (VTE). Although warfarin is effective at preventing a recurrence, it is inconvenient and raises the risk for bleeding. Newer anticoagulants have not been tested or approved for this population. The ASPIRE…
FDA Investigation Finds No Excess Bleeding Risk For Dabigatran
November 2, 2012 by 1 Comment
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the…
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…
Growing Popularity Of Dabigatran Leads To Increased Complications
June 7, 2012 by 1 Comment
Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now…
Aspirin Found To Prevent Recurrent Venous Thromboembolism
May 24, 2012 by 1 Comment
Aspirin can help prevent the recurrence of venous thromboembolism (VTE) after discontinuation of anticoagulation therapy, according to results of the WARFASA (the Warfarin and Aspirin) study published in the New England Journal of Medicine. Following 6 to 18 months of oral anticoagulation, 403 patients with first-time unprovoked VTE were randomized to aspirin (100 mg daily) or placebo…
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…
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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