CardioExchange Archive

April 2nd, 2013

Perspective On The Controversy About The TACT Trial

Sanjay Kaul, MD

The NIH TACT trial of chelation therapy has been the subject of intense criticism. In my opinion, the arguments that the TACT results are dubious or not valid are overstated. While the debate surrounding TACT is clearly warranted and welcome, I hope it generates more light than heat.

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March 29th, 2013

FDA Approves First SGLT2 Inhibitor for Diabetes

Larry Husten, PHD

The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated, in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes. The drug has been studied as monotherapy and in combination with […]

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March 26th, 2013

Controversial NIH Chelation Trial Published in JAMA

Larry Husten, PHD

Final results of the troubled NIH-sponsored Trial to Assess Chelation Therapy (TACT) testing chelation therapy for coronary disease have now been published in JAMA. Last November, when the preliminary results were presented at the American Heart Association meeting, the positive finding in favor of chelation therapy surprised many observers, though the investigators and senior AHA representatives expressed considerable caution […]

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March 25th, 2013

Selections from Richard Lehman’s Literature Review: March 25th

Richard Lehman, BM, BCh, MRCGP

This week’s topics include the effect of aliskiren on postdischarge mortality and readmissions among those hospitalized for HF, PFO closure, and more.

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March 25th, 2013

Emerging Biomarkers: How Reliable Is the Evidence?

Larry Husten, PHD

Novel biomarkers are the subject of intense controversy, with a bewildering variety of factions and perspectives seeking to elevate or dismiss any of a large number of proposed new measures. Now a new examination of the literature published online in JAMA Internal Medicine suggests that the evidence base used to evaluate novel biomarkers may be seriously compromised by selective reporting […]

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March 22nd, 2013

FDA Proposes Higher Regulatory Scrutiny for Automatic External Defibrillators

Larry Husten, PHD

Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist […]

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March 22nd, 2013

Europe and U.S. Diverge on Two New Drugs

Larry Husten, PHD

The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the […]

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March 22nd, 2013

Macrolide Antibiotic Linked to Increased CV Risk in Patients with Lung Conditions

Nicholas Downing, MD

Use of the macrolide clarithromycin in patients admitted with exacerbations of chronic obstructive pulmonary disease or community-acquired pneumonia is associated with increased risk for cardiovascular events, a BMJ study finds. Researchers examined outcomes among nearly 3000 patients admitted to U.K. hospitals with either condition. During 1 year of follow-up, there were roughly 450 new admissions […]

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March 21st, 2013

FDA Panel Gives Tepid Endorsement to Abbott’s MitraClip

Larry Husten, PHD

The FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to Abbott Laboratories’ MitraClip device on Wednesday. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing […]

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March 21st, 2013

DIGging In: Three Reasons Why the Recent Digoxin Study Is Not Relevant to Readmission

Harlan M. Krumholz, MD, SM

The evidence is just not compelling that this this drug would reduce hospital readmissions

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