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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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Avatar of Larry Husten, PHD

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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Avatar of Larry Husten, PHD

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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Avatar of Larry Husten, PHD

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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Avatar of Larry Husten, PHD

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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Avatar of Harlan M. Krumholz, MD, SM

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.

Avatar of Larry Husten, PHD

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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Avatar of Larry Husten, PHD

Large Analysis Supports Thrombolysis for Stroke (5 Aug 2014)

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Although thrombolysis for ischemic stroke has been widely recognized as beneficial, its use has been limited because of concerns about its effects in patients treated after 3 hours, in older patients, and in patients with mild and with severe strokes. Now a meta-analysis published in the Lancet offers evidence that the use of thrombolysis should be…

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Avatar of Larry Husten, PHD

More Questions Raised About Dabigatran (23 Jul 2014)

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Once again, dabigatran (Pradaxa) has raised the wrath of the critics. Several articles (see here, here, and here) and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The…

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Can Bivalirudin Stand the HEAT? (14 Jul 2014)

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Peter B Berger, MD

Harlan Krumholz interviews Peter Berger, an editorialist for the HEAT-PPCI study, about the paper’s findings.