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 28th, 2013
Case Report Of Durata Lead Failure Raises Fresh Concerns
Edward J. Schloss, MD
A case report of a failed St. Jude Medical Durata ICD lead was published yesterday, raising suspicions that this lead may share some of the same potential failure mechanisms of its troubled predecessor, the Riata lead. St. Jude’s ICD lead troubles date back to early case reports involving the Riata and Riata ST leads that ultimately […]
March 27th, 2013
Left to Our Many Devices, Which One Do We Choose?
Mark Dayer, MD PhD FRCP and James Fang, MD
A 63-year-old male smoker with type 2 diabetes presents for the first time with chest pain and shortness of breath at rest. He has no recent history of viral infection and no family history of heart failure or sudden cardiac death. Initial laboratory testing documents negative troponin, normal calcium, normal serum angiotensin-converting-enzyme (ACE) activity, and […]
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
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.
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 […]
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 […]
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 […]
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 […]