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Avatar of Larry Husten, PHD

Dabigatran Approved for Treatment of DVT and PE (7 Apr 2014)

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Boehringer Ingelheim announced on Monday that the FDA has approved dabigatran (Pradaxa) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. All three of the new oral anticoagulants — dabigatran, rivaroxaban…

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Avatar of Larry Husten, PHD

Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery (14 Mar 2014)

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The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have…

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Avatar of Larry Husten, PHD

AF Patients with Chronic Kidney Disease Also Benefit from Warfarin (4 Mar 2014)

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Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD….

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Avatar of Amy Herman, CardioExchange Staff

U.K. Geriatrician: Statins, Antihypertensives “Greatly” Overprescribed for Adults 80 and Older (27 Feb 2014)

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“The data strongly suggest that we are over-treating many healthy patients aged 80+ regarding stroke prevention,” concludes U.K. geriatrician Kit Byatt in a perspective published in Evidence-Based Medicine. Byatt offers a brief review of the evidence, noting that the large HYVET study in China and Europe showed only modest stroke-prevention benefits with antihypertensive therapy in…

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Avatar of Westby G Fisher, MD

What Is “Non-Valvular” Atrial Fibrillation? (24 Feb 2014)

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Westby G Fisher, MD

Wes Fisher attempts to figure out what the latest marketing phrase – non-valvular atrial fibrillation – really means.

Avatar of Larry Husten, PHD

FDA Once Again Rejects New Indication For Rivaroxaban (14 Feb 2014)

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The third time wasn’t the charm. The FDA today turned turned down — for the third time — the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA — for the second time — turned down the sNDA for rivaroxaban in…

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Avatar of Prashant Vaishnava, MD

Perioperative Beta-Blockade: Between a Rock and a Hard Place (13 Feb 2014)

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Prashant Vaishnava, MD, Vineet Chopra, MD, MSc, and Kim Allen Eagle, MD

In light of the continuing controversy over the Don Poldermans research misconduct case, Prashant Vaishnava, Vineet Chopra, and Kim Eagle discuss the use of perioperative beta-blockade.

Avatar of Larry Husten, PHD

FDA Advisory Panel Recommends Against Approval of Cangrelor (13 Feb 2014)

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote, the panel first rejected an indication for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI. The panel also voted unanimously to reject a second indication, for…

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Avatar of Larry Husten, PHD

FDA Reviewers Deliver Split Opinion on Cangrelor (10 Feb 2014)

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FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and provide sufficient reason to “refuse approval…on that fact alone.”  But two other reviewers recommend approval. On Wednesday the FDA’s Cardiovascular…

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Avatar of Larry Husten, PHD

Problems Persist Despite Gains in Oral Anticoagulant Use (28 Jan 2014)

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Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk for stroke. Many elderly patients are not receiving oral anticoagulants — either traditional warfarin or…

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