CardioExchange Archive

November 25th, 2013

FDA Reprimands 23andMe, Grants Breakthrough Status to Factor Xa Inhibitor, and Approves Promus Premier Stent

Larry Husten, PHD

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe: FDA Halts 23andMe Personal Genome Test: The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.  The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including […]

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November 20th, 2013

Consumption of Nuts Linked to Mortality Benefit

Larry Husten, PHD

Nut consumption has long been linked to healthy lifestyles. Now, a study in the New England Journal of Medicine extends the finding and demonstrates a strong association with improved mortality. Ying Bao and colleagues examined data from nearly 120,000 people enrolled in the Nurses’ Health Study and the Health Professionals Follow-up Study to assess the relationship of […]

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November 19th, 2013

Another New Anticoagulant Works Well in AF Patients

Larry Husten, PHD

Edoxaban, a direct oral factor Xa inhibitor, is the latest in the series of new oral anticoagulants seeking to take over the troubled role of warfarin in clinical practice. The results of ENGAGE-AF-TIMI 48 were presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine. In the trial, more than 21,000 […]

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November 19th, 2013

TACT Substudy Suggests Possible Strong Benefit for Chelation in Diabetics

Larry Husten, PHD

One year ago the results of the TACT trial were published in JAMA, sparking an enormous controversy over the propriety of publishing a trial suggesting that chelation therapy might be beneficial in people with cardiovascular disease. Chelation therapy has long been a staple of alternative medicine, but until the publication of TACT it had received […]

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November 18th, 2013

No Evidence That Statins Impact Cognitive Function

Larry Husten, PHD

In 2012 the FDA revised the label of statins to include a warning about reports that the drugs had been linked to memory loss or confusion. The FDA action appeared to be based largely on case reports. Despite concerns about this topic that have appeared sporadically in recent years, no high-quality review of the topic has appeared until now. […]

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November 18th, 2013

No Value for Renal-Artery Stenting in CORAL

Larry Husten, PHD

Previous small studies have failed to find any benefit associated with renal-artery stenting, but the trials have been small and were not powered for clinical outcomes. Now, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) trial, presented at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine, offers strong and persuasive evidence that […]

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November 18th, 2013

Controversy Erupts Over Accuracy of Cardiovascular Risk Calculator for Guidelines

Larry Husten, PHD

In the face of a highly critical story in the New York Times by Gina Kolata about the new cardiovascular guidelines, authors of the guidelines and leaders of the American Heart Association (AHA) and the American College of Cardiology (ACC) defended the value and integrity of the guidelines. The Times story claims that the cardiovascular risk calculator used to assess individual risk in the new guidelines is deeply […]

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November 18th, 2013

Replacement Versus Repair for Mitral Valve Regurgitation

Larry Husten, PHD

Surgery is thought to be life-saving for people who have ischemic mitral regurgitation, but it is unknown whether surgical repair or surgical replacement of the mitral valve is the better procedure. Repair is thought to result in fewer preoperative deaths and replacement is thought to have better long-term outcomes with a reduced incidence of recurrent […]

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November 15th, 2013

Hypertension Treatment Algorithm Fills in for Missing Guideline

Larry Husten, PHD

When the AHA and the ACC released four updated clinical guidelines earlier this week, a fifth document, the hypertension guideline, was conspicuous by its absence. According to the AHA and the ACC, the authors of the hypertension document have chosen to publish it independently. (No word has yet emerged about their reasons for doing so […]

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November 12th, 2013

Promising GSK Heart Drug Misses Primary Endpoint in 15,000-Patient Trial

Larry Husten, PHD

GlaxoSmithKline announced today that the first of two pivotal phase 3 trials with a new drug, darapladib, had failed to meet its primary endpoint. Full results of the trial will be presented at a scientific meeting. The STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) tested the effect of darapladib, an investigational Lp-PLA2 inhibitor, in more than […]

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