February 13th, 2014
FDA Advisory Panel Recommends Against Approval of Cangrelor
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote, the panel first rejected an indication for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI. The panel also voted unanimously to reject a second indication, for the […]
February 11th, 2014
FDA Investigating Heart Failure Risk Linked to Saxagliptin
Larry Husten, PHD
The FDA said today that it is conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin, a dipeptidyl peptidase 4 inhibitor, is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, Bristol Myers-Squibb.) The investigation stems […]
February 10th, 2014
FDA Reviewers Deliver Split Opinion on Cangrelor
Larry Husten, PHD
FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and provide sufficient reason to “refuse approval…on that fact alone.” But two other reviewers recommend approval. On Wednesday the FDA’s Cardiovascular and […]
February 5th, 2014
Eric Topol to Be AT&T’s Chief Medical Advisor
Larry Husten, PHD
AT&T announced today that it has appointed cardiologist Eric Topol as its Chief Medical Advisor. The company said he will “impact the design, development and delivery of AT&T’s healthcare IT solutions, connecting the healthcare ecosystem to enhance health outcomes and care delivery processes for patients and their caregivers.” In addition to his duties at AT&T, Topol will continue to serve as the the […]
February 4th, 2014
Blood Pressure Trajectory Over 25 Years Predicts Atherosclerosis Risk
Larry Husten, PHD
Everyone knows that blood pressure is one of the most important measurements of cardiovascular risk. Less well known is that most studies of blood pressure have relied on single or isolated measurements of blood pressure. Few studies have even attempted to examine the significance of blood pressure patterns over a long period of time. Now, in […]
February 3rd, 2014
The Not So Sweet Facts About Sugar
Larry Husten, PHD
A new study offers a broad overview of the use of sugar in the U.S. diet and its consequent health implications. The good news is that the growth in sugar intake appears to have stopped and may even have slightly declined. The bad news is that people still consume way too much sugar and that […]
February 3rd, 2014
FDA Evaluating Safety Of Testosterone Products
Larry Husten, PHD
The FDA has announced that it is evaluating the cardiovascular safety of testosterone products. The investigation is prompted by two recent published studies that found a significant increase in cardiovascular events in men who received testosterone therapy. The FDA said it had not concluded that testosterone is unsafe but recommended that “health care professionals should consider […]
January 31st, 2014
American College of Cardiology Announces Late-Breaking Clinical Trials
Larry Husten, PHD
The American College of Cardiology announced the lineup of late-breaking clinical trials for its upcoming annual meeting in Washington, DC. The opening session will include the most eagerly anticipated trials — the main results of Symplicity HTN-3 and the comparison of Corevalve and surgery in high-risk patients. Subsequent sessions will include several phase-3 trials of PCSK9 inhibitors. Here […]
January 30th, 2014
Johnson & Johnson Will Share Clinical Trial Data
Larry Husten, PHD
In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers. The company said that the Yale University Open Data Access (YODA) Project will serve as an independent third party “to review requests […]
January 28th, 2014
Problems Persist Despite Gains in Oral Anticoagulant Use
Larry Husten, PHD
Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk for stroke. Many elderly patients are not receiving oral anticoagulants — either traditional warfarin or […]