February 14th, 2011
AF Guidelines Updated to Incorporate Dabigatran
Larry Husten, PHD
Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation: Class I: Dabigatran is useful as an alternative to warfarin for […]
November 7th, 2010
RE-LY Substudy Finds Dabigatran Effective in Secondary Stroke Prevention
Larry Husten, PHD
A substudy of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrates that dabigatran is as effective in AF patients for secondary stroke prevention as it is for overall stroke prevention. In their paper in the Lancet Neurology, Hans-Christoph Diener and the RE-LY study group report the results of the trial in the predefined […]
November 2nd, 2010
Is Dabigatran More Cost-Effective Than Warfarin in AF?
Amy Herman
Dabigatran, newly approved by the FDA to prevent stroke in patients with atrial fibrillation (AF), might turn out to be a cost-effective alternative to warfarin, according to an Annals of Internal Medicine study. Using data from the RE-LY trial, James Freeman and colleagues modeled the quality-adjusted survival and cost-effectiveness of dabigatran compared with high- or low-dose warfarin […]
October 26th, 2010
Dabigatran to Cost $237 per Month at the Drugstore
Larry Husten, PHD
It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative says the wholesale acquisition cost (WAC) of the drug is set at $6.75 per day for 2 pills. The price will apply to both the 150-mg and the 75-mg capsules. According to knowledgeable experts, the retail […]
October 22nd, 2010
Warfarin or Dabigatran? The Thick and Thin of Deciding on an Anticoagulant
Anju Nohria, MD
These four patients are receiving chronic anticoagulation therapy. Read the descriptions of their cases and decide which, if any, of them you would switch to dabigatran. Case 1 A 69-year-old man with a history of hypertension and colon cancer was found to be in atrial fibrillation during a preoperative assessment for colon resection. Metoprolol was […]
October 22nd, 2010
What Do I Plan to Do with Dabigatran?
Richard A. Lange, MD, MBA
1. Discuss its pros (no need for INR monitoring, less bleeding than coumadin) and cons (cost, dyspepsia) with my atrial fibrillation patients 2. Avoid its use in patients with renal dysfunction (CrCl <60), liver disease, pregnancy or stroke within the past 6 months 3. Lament the absence of the INR monitoring requirement, which I currently […]
October 20th, 2010
Finally: Dabigatran – A New Oral Anticoagulant Is Approved by the FDA
Westby G Fisher, MD
CardioExchange welcomes this guest post reprinted with permission from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem, Evanston, IL, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes. A new era of nonvalvular atrial fibrillation management has arrived. Tuesday, the FDA approved the first new […]
October 20th, 2010
Dabigatran Is Approved
John Mandrola, MD, FACC
John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog Dr John M. There can only be one cardiology story to discuss today. Tuesday, the FDA approved dabigatran (Pradaxa), an oral anticoagulant for the prevention of stroke in atrial fibrillation. Previously, the only drug approved to prevent stroke in […]
October 20th, 2010
FDA Approves Dabigatran for Stroke Prevention in Atrial Fibrillation
Larry Husten, PHD
The FDA announced on Tuesday that it has approved Pradaxa (dabigatran, Boehringer Ingelheim) for the prevention of stroke and blood clots in patients with atrial fibrillation. The drug will be available in 75-mg and 150-mg capsules. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said […]
September 20th, 2010
FDA Panel Unanimously Recommends Approval for Dabigatran
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw […]