February 12th, 2013
ACC and STS Break New Ground to Test TAVR for Unapproved Uses
Larry Husten, PHD
In a startling break with tradition, the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such […]
February 11th, 2013
FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec
Larry Husten, PHD
The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee […]
February 8th, 2013
Xarelto Effective in Medically Ill Patients, But at High Bleeding Cost
Larry Husten, PHD
The recent arrival of novel oral anticoagulants has provided important new options for treating and preventing venous thromboembolism (VTE). New indications for these drugs have been granted for patients with atrial fibrillation and for patients who have undergone orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not […]
February 6th, 2013
Genetic Study Identifies Strong Links to Aortic Valve Disease
Larry Husten, PHD
A genetic component is believed to play an important role in valvular heart disease, but the specific genes involved have not been identified. Now an interntional group of researchers has identified genetic variations that increase the risk for valvular calcification. In an article published in the New England Journal of Medicine, members of the Cohorts for Heart and Aging […]
February 5th, 2013
Back To The Future: Resurrected Data From 1960s Trial Might Impact Contemporary Dietary Fat Debate
Larry Husten, PHD
In an exceedingly strange turn of events, data from a clinical trial dating from the 1960s, long thought to be lost, has now been resurrected and may contribute important new information to the very contemporary controversy over recommendations about dietary fat composition. The American Heart Association has long urged people to increase their consumption of polyunsaturated […]
February 5th, 2013
ACE Inhibitor Improves Walking in People with Peripheral Artery Disease
Larry Husten, PHD
Giving an ACE inhibitor to people with peripheral artery disease (PAD) and intermittent claudication reduces pain and increases walking time, according to a new study published in JAMA. Currently the pharmacologic options for this patient population are few and have limited efficacy. Researchers at three Australian hospitals randomized 212 patients with PAD to receive the ACE inhibitor ramipril or placebo for 24 […]
February 2nd, 2013
European Heart Journal Retracts Main Paper of the Kyoto Heart Study
Larry Husten, PHD
The 2009 report of the Kyoto Heart Study on the add-on effect of valsartan in hypertension has been retracted with a terse comment by the editors of the European Heart Journal.
January 30th, 2013
Small Study Suggests Yoga May Benefit AF Patients
Larry Husten, PHD
A study published online in the Journal of the American College of Cardiology suggests that yoga may benefit people who have atrial fibrillation. The study, which the authors describe as “a small, proof-of-concept study,” is the first of its kind. The findings raise the possibility that yoga may reduce AF symptoms and arrhythmia burden. Other physiological and […]
January 29th, 2013
FDA Approves Mipomersen for Homozygous Familial Hypercholesterolemia
Larry Husten, PHD
The FDA said today that it had granted approval to the novel cholesterol-lowering drug mipomersen sodium for use as an adjunct to diet and drug therapy in patients with homozygous hypercholesterolemia. The drug, which was developed by Isis Pharmaceuticals, will be marketed under the brand name of Kynamro by Genzyme. Kynamro was approved as an orphan drug, which the […]
January 29th, 2013
Popular Antidepressants May Prolong QT Interval
Larry Husten, PHD
In August 2011 the FDA issued a safety communication recommending that the extremely popular antidepressant citalopram (Celexa) not be used at doses greater than 40 mg/day because of a potential increased risk for serious cardiac arrhythmias associated with prolongation of the QT interval. Now a study published in BMJ lends support to this warning and suggests that other antidepressants may […]