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 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.
January 10th, 2014
ESC Spotlights Growing Problem of Radiation Exposure in Cardiology
Larry Husten, PHD
Both medical professionals and patients have a general sense that radiation used in medical imaging and procedures carries some danger, but they often underestimate the risk. And certainly most are unaware of the increasingly large proportion of the problem occurring during cardiology procedures. “Cardiologists today are the true contemporary radiologists,” said Eugenio Picano, lead author […]
January 9th, 2014
Pivotal Renal Denervation Trial Fails to Show Efficacy
Larry Husten, PHD
Medtronic announced today that the SYMPLICITY HTN-3 trial of its much-anticipated renal denervation device had failed to meet its primary efficacy endpoint. Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension. […]
January 9th, 2014
Hospital Quality Helps Explain Some Racial Disparities in CABG Outcomes
Larry Husten, PHD
It has long been known that racial disparities exist in health care. A large body of research has found that nonwhite patients have worse outcomes than whites. But it has been difficult to understand the underlying reasons for these disparities. Now a new study offers evidence that, at least in the case of bypass surgery, […]
