September 28th, 2012
Subcutaneous ICD Gains FDA Approval
Larry Husten, PHD
The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) System from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and therefore does not need to be guided by X-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage […]
September 27th, 2012
FDA Sets New Decision Date for Eliquis (Apixaban)
Larry Husten, PHD
The FDA will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly […]
September 26th, 2012
Treading Water During the Post-MI Waiting Period
Harlan M. Krumholz, MD, SM and James Fang, MD
Does your institution use the LifeVest strategy routinely during the waiting period after an MI?
September 26th, 2012
Merck Returns to Cardiome All Rights to Atrial Fibrillation Drug Vernakalant
Larry Husten, PHD
Merck and Cardiome announced today that Merck is returning to Cardiome all marketing and development rights for the atrial fibrillation (AF) drug vernakalant. An intravenous formulation of vernakalant is marketed in Europe as Brinavess. It has not been approved in the United States, though it received a positive recommendation from the FDA’s Cardiovascular and Renal […]
September 25th, 2012
AHA Urges More Education and Support for ICD Patients
Larry Husten, PHD
Despite, and perhaps sometimes because of, their life-saving benefits, ICDs are associated with a host of complex psychosocial problems, but clinicians and caregivers receive little training to deal with these problems. In response to these concerns, the American Heart Association (AHA) has published a scientific statement in Circulation to provide a “comprehensive review of what is and is not […]
September 25th, 2012
Another One Bites the Dust: Diovan Patent Expires but Generic Valsartan Is MIA
Larry Husten, PHD
Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drug maker Mylan. As reported on Pharmalot, Ranbaxy, the embattled generic drug maker, holds the […]
September 25th, 2012
Novartis Announces Top Line Results for Phase 3 Trial of New Acute Heart Failure Drug
Larry Husten, PHD
Novartis has announced preliminary results from the RELAX-AHF trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea. Novartis also reported a reduction in all-cause mortality at 6 months. However, it should be noted that […]
September 24th, 2012
‘Dramatic’ Increase in Bleeding Accompanies Addition of Oral Anticoagulant Therapy in ACS
Larry Husten, PHD
The newer oral anticoagulants may help reduce ischemic events after an acute coronary syndrome (ACS), but only at the cost of a “dramatic” increase in bleeding complications, according to a new meta-analysis published in the Archives of Internal Medicine. Hungarian researchers performed a systematic review and meta-analysis of seven trials in which 31,286 ACS patients […]
September 24th, 2012
Selections from Richard Lehman’s Literature Review: September 24th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include papers on punishing health care fraud, how physicians interpret research funding disclosures, and the association between BP and mortality in those newly diagnosed with type-2 diabetes.
September 24th, 2012
Stress and Coronary Heart Disease: What Role Does Gender Play?
Xiao Xu, PhD
Xiao Xu examines the unique stressors – both at home and at work – that women and men may face.