January 20th, 2014
Selections from Richard Lehman’s Literature Review: January 20th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include coronary artery calcium density and the risk for incident CV events, dietary fiber intake and the risk for CV disease, and more.
January 20th, 2014
FDA Grants Earlier Than Expected Approval for Medtronic’s CoreValve
Larry Husten, PHD
The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. The approval was based largely on results from the Extreme Risk Study of the […]
January 17th, 2014
FDA Panel Once Again Rejects ACS Indication for Rivaroxaban
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee has once again turned down the supplemental new drug application for an acute coronary syndrome (ACS) indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. Although originally the subject of high praise […]
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 […]
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 16th, 2014
Are All Carotid Stenting Systems Equal?
Jay Giri, MD, MPH and Robert W. Yeh, MD MSc MBA
Jay Giri and Robert W. Yeh discuss their research group’s analysis of patient-registry data on embolic protection devices that are commonly used in carotid artery stenting.
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 13th, 2014
Selections from Richard Lehman’s Literature Review: January 13th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include the risk for MI and ischemic heart disease among overweight and obese people with and without metabolic syndrome, and the lower risk for CV events in postmenopausal women taking estradiol compared with conjugated equine estrogens.