July 29th, 2011
Controversial IOM Report Highly Critical of 510(k) Process
Larry Husten, PHD
The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The […]
July 29th, 2011
Less May Be More, But Stents Are Neither Good Nor Bad
Larry Husten, PHD
A few days ago, the distinguished healthcare writer Shannon Brownlee wrote a provocative blog post about the overuse of stents. A key piece of evidence that she used was a paper co-authored by Grace Lin and Rita Redberg, in which focus groups of cardiologists cheerfully admitted that they would give stents to hypothetical patients who were, according to the current guidelines, not […]
July 28th, 2011
When Will Palliative Care and Hospice Discussions Be Considered Normal?
Heather M Johnson, MD, MS
Guest blogger John Mandrola shares a clinical anecdote that gets to the heart of the matter on this delicate issue.
July 28th, 2011
AstraZeneca Sets Premium Price for Ticagrelor
Larry Husten, PHD
AstraZeneca will be charging a premium price for its new antiplatelet drug ticagrelor (Brilinta). Wall Street analyst Timothy Anderson reports that the daily treatment cost for the drug will be $7.24 on a wholesaler acquisition cost (WAC) basis, which is approximately 20% higher than the daily cost of $6.08 for clopidogrel (Plavix) and about 25% […]
July 27th, 2011
Mixed Results for New Implantable Device to Treat Resistant Hypertension
Larry Husten, PHD
A phase III trial has yielded mixed results for an experimental implantable device that uses baroreflex activation therapy (BAT) to treat resistant hypertension. The article on the manufacturer-funded Rheos Pivotal Trial, by John Bisognano and colleagues, has been published online in the Journal of the American College of Cardiology. The Rheos device was implanted in […]
July 26th, 2011
Coronary and Cerebrovascular Disease May Differ in Their Heritability
Larry Husten, PHD
Although coronary and cerebrovascular disease usually receive equal weight when family history is assessed as a risk factor, a new study suggests that family history may play a more important role in MI and ACS than in stroke or TIA. In an article published in Circulation: Cardiovascular Genetics, Amitava Banerjee and colleagues report the results […]
July 25th, 2011
Panel: Will You Prescribe Ticagrelor (Brilinta)?
CardioExchange Editors, Staff
Three experts discuss whether — and with which patients — they will use ticagrelor in clinical practice.
July 25th, 2011
Adding HbA1c Measurements Improves CV Risk Prediction in Diabetics
Larry Husten, PHD
Current risk prediction models classify diabetes as equivalent to established cardiovascular disease. Now, a new report from the Women’s Health Study and the Physician’s Health Study II suggests that adding HbA1c measurements to the model can improve risk prediction and lead to downward classification of some diabetics. In a paper published in Archives of Internal […]
July 24th, 2011
APPRAISE-2 Dashes Hope of Adding Anticoagulant to Antiplatelet Therapy in ACS
Larry Husten, PHD
A large phase 3 trial of an investigational factor Xa inhibitor, when added to antiplatelet therapy in ACS patients, was stopped early because of bleeding complications.
July 21st, 2011
FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone
Larry Husten, PHD
The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis), and the European Medicines Agency (EMA) has updated its reviews of dronedarone and 2 other drugs that also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer). The FDA and dronedarone: The FDA issued a safety communication […]