October 9th, 2012
Observational Study Links Common Household Chemical to Cardiovascular Disease
Larry Husten, PHD
High levels of a man-made chemical widely used in common household products and detectable in more than 98% of people may increase the risk for cardiovascular (CV) disease and peripheral arterial disease (PAD), according to a study published in the Archives of Internal Medicine. (The study was published online in September and will appear in this week’s […]
October 4th, 2012
U.K. Study Casts Doubts on Value of Type 2 Diabetes Screening
Larry Husten, PHD
The dramatic growth in type 2 diabetes has resulted in increased interest in screening programs. Now a new study published in the Lancet raises concerns that screening programs may not result in long-term improvement in outcomes. In the ADDITION-Cambridge study, investigators in the U.K. randomized general practices to either screening or no screening. The practices allocated to screening were […]
October 3rd, 2012
What Is the Benefit of Adding CRP to Risk Factor Assessment?
Larry Husten, PHD
In recent years, controversy has swirled around the role of inflammation in cardiovascular disease and the relative worth of measuring novel risk factors like C-reactive protein (CRP). Now, in a paper published in the New England Journal of Medicine, researchers from the Emerging Risk Factors Collaboration provide detailed calculations that estimate the benefits of adding inflammatory markers to […]
October 2nd, 2012
Registry Study Raises Questions About Cardioprotective Effect of Beta-Blockers
Larry Husten, PHD
Although beta-blockers have been a cornerstone of therapy for patients with coronary artery disease for more than a generation, a new study in JAMA suggests that that in the modern era, beta-blockers might not improve outcomes. Sriapl Bangalore and colleagues analyzed data from 44,708 patients enrolled in the Reduction of Atherothrombosis for Continued Health (REACH registry), […]
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 praised when […]
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 exclusive […]
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 the […]