April 5th, 2013
Cardio-Oncology: Who Needs It?
John Ryan, MD
Our panel sketches out the scope of this growing discipline.
April 4th, 2013
Registry Study Offers Reassurance About Safety and Efficacy of Dabigatran
Larry Husten, PHD
As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American […]
April 3rd, 2013
International Cardiovascular Device Registries: The Next Big Thing
Larry Husten, PHD
A new initiative involving a wide variety of stakeholders — the FDA, the American College of Cardiology, the Society of Thoracic Surgeons, industry, medical journals, and others — could lead to an enormous international cooperative effort to make device registries a standard part of the practice of cardiology. This will be a “huge step,” said David […]
April 2nd, 2013
Lifelong Statin Sentence Now Includes Furloughs
Larry Husten, PHD
Although the benefits of statins are among the best documented in all of medicine, continuous lifelong statin therapy is not always easy to achieve in clinical practice. Now a new retrospective study suggests that although clinical events causing temporary cessation of statin therapy occur often, most of these patients are later able to resume statin therapy. […]
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.
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 […]
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 […]
March 26th, 2013
Should the Use of IVC Filters be Filtered Until We Have More Data?
Behnood Bikdeli, M.D.
There’s been a remarkable increase in the use of IVC filters, but what is the evidence base behind this mechanistically appealing approach?
March 25th, 2013
Once Again FDA Rejects Oral Treprostinil for Pulmonary Arterial Hypertension
Larry Husten, PHD
For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH). The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that oral treprostinil will play […]
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 bias. […]