CardioExchange Archive

March 7th, 2012

Software Tool Could Provide Early Warning of ICD Lead Failure

Larry Husten, PHD

In recent years, defects in ICD leads have caused recalls and provoked broad concerns among healthcare professionals and patients alike about the safety and reliability of ICDs and other implanted cardiac devices. Now a key player in these events proposes that a computer software program can better monitor ICD leads and provide earlier warnings of […]

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March 5th, 2012

Statins and Diabetes: Real Concern or Much Ado About Nothing?

Larry Husten, PHD

In a New York Times Op-Ed piece on Monday, Eric Topol comments on last week’s announcement by the FDA that it was changing the label for statins. Topol focuses on the new warning that statins raise the risk of diabetes. He opens with a provocative statement: We’re overdosing on cholesterol-lowering statins, and the consequence could be a sharp increase […]

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March 2nd, 2012

Four Cardiovascular Societies Release Criteria for TAVR Programs and Operators

Larry Husten, PHD

A newly released statement contains detailed recommendations about the requirements necessary for hospitals and physicians to participate in transcatheter aortic valve replacement (TAVR)  programs. The expert consensus document was released jointly by the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS) and the Society for Thoracic […]

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March 1st, 2012

Decision on Apixaban (Eliquis) Pushed Back By 3 Months

Larry Husten, PHD

Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by 3 months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant apixaban (Eliquis). The application is for their important indication of stroke prevention in atrial fibrillation. The […]

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February 28th, 2012

FDA Revises the Safety Labeling of Statins

Larry Husten, PHD

The FDA today announced important new changes to the safety language on the labels of statins: Routine periodic monitoring of liver enzymes is no longer recommended. Serious liver injury associated with statins is “rare and unpredictable in individual patients” and “routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side […]

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February 28th, 2012

Slow Uptake of Transcatheter Aortic Valves: Learning from History?

Larry Husten, PHD

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that its introduction would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs […]

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February 28th, 2012

FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients

Larry Husten, PHD

The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of […]

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February 27th, 2012

Meta-Analysis Finds No Advantages for PCI Over Medical Therapy in Stable Patients

Larry Husten, PHD

Patients with stable coronary artery disease (CAD) today do no better with stents than with medical therapy, according to a new meta-analysis published in the Archives of Internal Medicine. Kathleen Stergiopoulos and David Brown identified 8 trials with 7,229 patients comparing stents to medical therapy in which stents were used in the majority of PCI cases. ”By limiting the […]

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February 23rd, 2012

FDA Grants MI Indication for Drug-Eluting Stents

Larry Husten, PHD

Boston Scientific announced on Wednesday that the FDA had approved the use of its Ion and Taxus Liberte paclitaxel-eluting stents for the treatment of patients with MI. These are the first drug-eluting stents to receive a specific indication for MI. The new indication is based on data from the Taxus clinical program and the HORIZONS-AMI trial. […]

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February 23rd, 2012

FDA Advisory Panel Gives Green Light to Qnexa Diet Pill

Larry Husten, PHD

Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of  phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this […]

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