February 28th, 2012
FDA Revises the Safety Labeling of Statins
Larry Husten, PHD
The FDA today announced important new changes to the safety language on the labels of statins: Routine periodic monitoring of liver enzymes is no longer recommended. Serious liver injury associated with statins is “rare and unpredictable in individual patients” and “routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare […]
February 28th, 2012
Slow Uptake of Transcatheter Aortic Valves: Learning from History?
Larry Husten, PHD
Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that its introduction would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs […]
February 28th, 2012
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
Larry Husten, PHD
The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of […]
February 27th, 2012
Meta-Analysis Finds No Advantages for PCI Over Medical Therapy in Stable Patients
Larry Husten, PHD
Patients with stable coronary artery disease (CAD) today do no better with stents than with medical therapy, according to a new meta-analysis published in the Archives of Internal Medicine. Kathleen Stergiopoulos and David Brown identified 8 trials with 7,229 patients comparing stents to medical therapy in which stents were used in the majority of PCI cases. ”By limiting the […]
February 27th, 2012
Selections from Richard Lehman’s Weekly Review: Week of February 27th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include a study on chest pain (or lack thereof) in patients with MI and a trial of cardiovascular family history taking.
February 24th, 2012
A Call for Help to Reduce Readmissions
Harlan M. Krumholz, MD, SM
The national focus on readmissions (e.g., Partnership for Patients) has yet to yield improvements in performance. Many clinicians and hospitals are seeking help in their efforts to reduce readmission rates. Hospital to Home, a national quality improvement initiative led by the American College of Cardiology and the Institute for Healthcare Improvement, has posted a list […]
February 23rd, 2012
FDA Grants MI Indication for Drug-Eluting Stents
Larry Husten, PHD
Boston Scientific announced on Wednesday that the FDA had approved the use of its Ion and Taxus Liberte paclitaxel-eluting stents for the treatment of patients with MI. These are the first drug-eluting stents to receive a specific indication for MI. The new indication is based on data from the Taxus clinical program and the HORIZONS-AMI […]
February 23rd, 2012
Reality Check: Do 42% of Women with AMI Present Without Chest Pain?
Harlan M. Krumholz, MD, SM
I am reading the new paper from NRMI in JAMA on the association of age and sex with AMI symptom presentation and am struck by the finding that 35% of the patients did not present with chest pain. This percentage is higher than I have seen elsewhere. In our recent studies, spanning many sites, we […]
February 23rd, 2012
FDA Advisory Panel Gives Green Light to Qnexa Diet Pill
Larry Husten, PHD
Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this […]
February 22nd, 2012
What’s Good for the Goose Is Good for the … Swan?
Tariq Ahmad, MD, MPH
A colleague of mine who is a cardiology fellow recently made this confession: “I really love doing procedures. I can’t wait until the new patient gets here so we can Swan him.” Playing devil’s advocate, I asked: “Would you want to be ‘Swanned’ if you were admitted to the CCU?” Astonished, she replied, “Of course […]