CardioExchange Archive

February 13th, 2014

Perioperative Beta-Blockade: Between a Rock and a Hard Place

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.

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February 13th, 2014

FDA Advisory Panel Recommends Against Approval of Cangrelor

Larry Husten, PHD

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 the […]

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February 10th, 2014

FDA Reviewers Deliver Split Opinion on Cangrelor

Larry Husten, PHD

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 and […]

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January 28th, 2014

Problems Persist Despite Gains in Oral Anticoagulant Use

Larry Husten, PHD

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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January 17th, 2014

FDA Panel Once Again Rejects ACS Indication for Rivaroxaban

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has once again turned down the supplemental new drug application for an acute coronary syndrome (ACS)  indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. Although originally the subject of high praise when […]

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January 16th, 2014

FDA Advisory Panel Votes in Favor of Approval for Merck’s Vorapaxar

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. The committee voted in favor of the drug […]

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January 3rd, 2014

FDA Plans New Safety Assessment of Dabigatran (Pradaxa)

Larry Husten, PHD

Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. On December 30 the FDA posted a request for public comment on a proposed […]

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December 23rd, 2013

Statins: Targeting Risk, but Risking Diabetes?

Emma Morton-Eggleston, MD, MPH and Richard Lehman, BM, BCh, MRCGP

Emma Morton-Eggleston and Richard Lehman share their correspondence with us, in which they debate whether it’s worth using statins to target CV risk if they might increase other risks, such as diabetes.

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December 18th, 2013

New Trial Confirms Role for Dabigatran in Venous Thromboembolism

Larry Husten, PHD

A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for […]

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December 16th, 2013

Possible New Lease on Life for Vorapaxar and Rivaroxaban for ACS

Larry Husten, PHD

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and […]

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