Conference Coverage

Edoxaban pivotal trial shows VTE efficacy, safety

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Edoxaban continues new oral anticoagulant growth

It appears that the Hokusai-VTE results proved the hypothesis that edoxaban is noninferior to warfarin, and also important was that in higher-risk patients with significant pulmonary embolisms, edoxaban was better.

The emergence of the oral factor X inhibitors is giving physicians a new option for treatment. These drugs are much more convenient to use than warfarin; diet does not interfere with treatment, and blood draws aren’t necessary. It looks like the benefits from the new factor X inhibitors may be class effects; the results have been consistent from one drug to the next. But there is the limitation right now of their relatively high cost. I hope that eventually the cost differential won’t be as prohibitive as it probably is today for some patients.

Physicians and patients in the United States are slowly starting to use these drugs routinely in patients with VTE, and in other settings, such as to prevent clot formation and strokes in patients with atrial fibrillation. In mid-2013, about 10%-12% of patients with atrial fibrillation are being treated with one of the new oral anticoagulants, a group of drugs that also includes dabigatran (Pradaxa). I think there will gradually be increasing use of these drugs in place of warfarin as people grow more familiar and comfortable with them.

Dr. William A. Zoghbi is professor of medicine and director of the Cardiovascular Imaging Institute at the DeBakey Heart and Vascular Center of Methodist Hospital in Houston. He said that he had no relevant disclosures. Dr. Zoghbi made these comments in an interview.


 

AT ESC 2013

The data collected on all three oral factor X inhibitors so far suggest that they all are "noninferior to standard treatment and are also not inferior and most likely superior for safety, with apixaban showing the best safety profile so far," said Dr. Konstantinides, who was the designated discussant for Dr. Büller’s report. But Dr. Konstantinides also warned that these new drugs will need to "justify their high cost" by showing improvements in patient satisfaction with their treatment and quality of life, and by lowering overall health-care costs by lowering the number of rehospitalizations in VTE patients.

Hokusai-VTE was sponsored by Daiichi-Sankyo, the company developing endoxaban. Dr. Büller said that he has received honoraria from Daiichi Sankyo, as well as from Bayer, Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, Isis, and Thrombogenics. Dr. Büller also served as a principal investigator for the VTE pivotal trials of rivaroxaban and apixaban. Dr. Zoghbi said that he had no relevant disclosures. Dr. Konstantinides has been a speaker for and an advisor to Boehringer Ingelheim, Bayer, and Pfizer/Bristol-Myers Squibb.

mzoler@frontlinemedcom.com

Twitter:@mitchelzoler

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