October 3rd, 2011
Guidelines for Managing Peripheral Artery Disease Updated
Larry Husten, PHD
The ACC and the AHA have released updated guidelines for managing peripheral artery disease (PAD). The document is available online in the Journal of the American College of Cardiology and in Circulation. The new guidelines place a greater emphasis on tobacco cessation, requesting healthcare providers to consistently ask patients about their smoking status and to offer support to help them […]
September 29th, 2011
Rivaroxaban Meets Primary Endpoint in ATLAS ACS TIMI 51
Larry Husten, PHD
Bayer AG announced today that in the ATLAS ACS TIMI 51 trial, rivaroxaban (Xarelto, Bayer and Johnson & Johnson) had met the primary efficacy endpoint in patients with acute coronary syndrome (ACS). The drug was associated with “a statistically significant reduction in the rate of events for the primary composite endpoint of cardiovascular death, myocardial infarction […]
September 23rd, 2011
Former NEJM Editor Questions Decision to Publish ARISTOTLE
Alison Bass, MLA and BA
The following guest post is reprinted with permission from the blog of Alison Bass. At a Harvard event last night honoring Paul Thacker, a former investigator for Senator Chuck Grassley, someone in the audience wanted to know how the topic of Thacker’s talk — Dollars for Doctors: Who owns your physician? — was related to the soaring cost of medical care in […]
September 23rd, 2011
Rivaroxaban (Xarelto) Gets Positive Recommendation for AF and DVT in Europe
Larry Husten, PHD
The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic embolism in AF, according to Bayer HealthCare. CHMP has also recommended the drug’s approval for the treatment of DVT and for the prevention of recurrent DVT and PE following acute DVT. […]
September 12th, 2011
Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran
Larry Husten, PHD
Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that […]
September 8th, 2011
FDA Advisory Panel Gives Yellow Light to Rivaroxaban
Larry Husten, PHD
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers, […]
September 6th, 2011
FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)
Larry Husten, PHD
FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers is […]
September 2nd, 2011
When Patients Can’t Afford a Medication
Beth Waldron, MA
Editor’s Note: The following guest post by Beth Waldron is reprinted with permission from ClotConnect, a valuable resource for patients about blood clots and clotting disorders. Waldron is the program director of the UNC-Chapel Hill Blood Clot Outreach Program. Prescription Assistance: When Patients Can’t Afford a Medication Beth Waldron, Program Director of the Clot Connect project, writes…. Approximately 1 in 5 […]
August 30th, 2011
Is Warfarin Still the First Choice in Atrial Fibrillation?
Stephen Fleet, MD
There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last. A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran. Even Dr. Ezekowitz, the warfarin protagonist for purposes […]
August 29th, 2011
ESC: A Closure Device and a Warfarin Substitute for High-Risk AFib Patients
Stephen Fleet, MD
How can we manage a patient with atrial fibrillation and contraindications to warfarin therapy such as recurrent severe bleeding — a common scenario in clinical practice? Data from the manufacturer-sponsored ASAP study (ASA Plavix Feasibility Study with WATCHMAN Left Atrial Appendage Closure Technology) provides some hope, beyond what we had learned from the Protect AF […]