January 16th, 2014
FDA Advisory Panel Votes in Favor of Approval for Merck’s Vorapaxar
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. The committee voted in favor of the drug […]
January 16th, 2014
Co-Chairs of JNC8 Hypertension Guidelines Address a Challenging Case
Justin Sadhu, MD, Paul James and Suzanne Oparil, MD
Cardiology fellow Justin Sadhu presents a challenging case to JNC8 hypertension guideline co-chairs Paul James and Suzanne Oparil.
January 14th, 2014
All Lots of Liptruzet In U.S. Recalled Over Packaging Defect
Larry Husten, PHD
Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the U.S. The company said the recall was due to a packaging defect that could potentially allow air and moisture to affect the quality of the drug, although “the likelihood of the packaging defects decreasing the […]
January 13th, 2014
Minority Report: Five Guideline Authors Reject Change in Systolic Blood Pressure Goal
Larry Husten, PHD
It didn’t seem possible, but the guideline situation just got even more confusing. Last December, after years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, […]
January 13th, 2014
Merck’s Vorapaxar Gets Positive FDA Review
Larry Husten, PHD
A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with […]
January 6th, 2014
Mediterranean Diet Protects Against Diabetes, Regardless of Weight Loss
Larry Husten, PHD
Even if it doesn’t lead to weight loss, a Mediterranean diet could help prevent the onset of type 2 diabetes, according to a subanalysis of last year’s influential PREDIMED study. In the main trial, reported in the New England Journal of Medicine, nearly 7500 people at high risk for cardiovascular disease were randomized to a low-fat […]
January 6th, 2014
Looking Old for Your Age
Mette Christoffersen, MSc (Pharm)
Mette Christoffersen and Anne Tybjaerg-Hansen discuss their finding that visible age-related signs are associated with increased risk of coronary disease independent of chronological age and other CV risk factors.
January 6th, 2014
A Cross-Section of CPR Training in U.S. Counties
Monique Anderson, MD
Monique L. Anderson discusses her research group’s study of CPR training rates in the United States.
January 3rd, 2014
2013: The Year of the Guideline
John W McEvoy, MB BCh BAO
John (Bill) McEvoy looks back at 2013’s guidelines and shares his thoughts on what is needed going forward and his hopes for how we’ll use guidelines in the future.
January 3rd, 2014
FDA Plans New Safety Assessment of Dabigatran (Pradaxa)
Larry Husten, PHD
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. On December 30 the FDA posted a request for public comment on a proposed […]