Posts Tagged ‘SPAF’

February 14th, 2011

AF Guidelines Updated to Incorporate Dabigatran

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 […]

February 10th, 2011

Apixaban Better Than Aspirin for Stroke Prevention in AF Patients Unable to Take Warfarin

A new trial presented at the American Stroke Association’s International Stroke Conference and published online in the New England Journal of Medicine demonstrates that the novel factor Xa inhibitor apixaban is better than aspirin for the prevention of stroke in AF patients who are unable to take warfarin. Stuart Connolly and investigators in the AVERROES (Apixaban […]

December 20th, 2010

Dronedarone, Rate Control, and Catheter Ablation Incorporated in Updated AF Guidelines

A focused update on the guidelines for the management of atrial fibrillation has been released by the American College of Cardiology, American Heart Association, and Heart Rhythm Society. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights: Dronedarone can reduce […]

November 15th, 2010

ROCKET AF Hits Chicago

ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest. The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin in […]

November 7th, 2010

RE-LY Substudy Finds Dabigatran Effective in Secondary Stroke Prevention

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 1st, 2010

Rivaroxaban Equals Warfarin in ROCKET AF

Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the  trial’s scheduled presentation at the AHA on November 15. ROCKET AF randomized more than 14,000 patients with nonvalvular AF to either rivaroxaban or warfarin. The goal of the […]

October 26th, 2010

Dabigatran to Cost $237 per Month at the Drugstore

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 20th, 2010

FDA Approves Dabigatran for Stroke Prevention in Atrial Fibrillation

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

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 […]

September 16th, 2010

FDA: Dabigatran Gains, Lorcaserin Loses

An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at […]