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Ticagrelor Improves Outcomes After Myocardial Infarction (14 Jan 2015)

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For the first time, a very large trial has shown that dual antiplatelet therapy (DAPT) improves cardiovascular outcomes when given to patients 1 to 3 years after a myocardial infarction. Because DAPT has been shown previously to reduce the high risk of recurrent events for up to a year following an MI, it is considered to be standard…

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FDA Approves New Oral Anticoagulant from Daiichi Sankyo (9 Jan 2015)

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And then there were four. Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace: dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis). All four drugs…

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New Anticoagulant Spotlights Major Role for the Intrinsic Pathway (8 Dec 2014)

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Sanjay Kaul, MD and Ethan J Weiss, M.D.

Sanjay Kaul and Ethan Weiss discuss an entirely new approach to anticoagulation.

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Agent Could Potentially Reverse Anticoagulation Associated with Edoxaban (6 Nov 2014)

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PER977 — a cation that binds to all of the new oral anticoagulants and heparin — may help reverse the anticoagulant effects of edoxaban, according to results of an industry-conducted trial published in the New England Journal of Medicine. Edoxaban, an oral factor Xa inhibitor, was recently recommended for approval by an FDA advisory panel….

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AF Patients at Increased Risk for Silent Strokes (3 Nov 2014)

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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…

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Economic Study Finds VTE Prophylaxis with Low-Molecular-Weight Heparin Cost Effective (3 Nov 2014)

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Critically ill patients in the hospital are at high risk for developing venous thromboembolism (VTE). The 2011 PROTECT trial compared the two most common drug strategies used to prevent VTE — unfractionated heparin (UFH) and dalteparin, a low-molecular-weight heparin (LMWH) —  and found no difference between the two groups in the primary endpoint of the trial, leg deep-vein thrombosis….

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FDA Advisory Panel Gives Tepid Support to New Anticoagulant (31 Oct 2014)

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On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban (Savaysa). The outcome will likely result in a drug that will be on the market, but that few physicians will prescribe until further studies are performed. Edoxaban will almost certainly become the fourth new oral anticoagulant (NOAC)…

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FDA Panel Gives Cautious Endorsement to Novel Boston Scientific Device (9 Oct 2014)

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The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. The panel wrestled…

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Another Reason for Open Access to Clinical Trial Data? (7 Oct 2014)

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Harlan M. Krumholz, MD, SM

A correction to the RE-LY trial results, partly brought to light because of litigation, has Harlan Krumholz wondering if this is another example of why we should have open access to clinical trial data.

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FDA Grants Apixaban Expanded Indication for Venous Thromboembolism (21 Aug 2014)

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The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new…

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