April 27th, 2015
A new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that this much-anticipated new class of drugs dramatically lowers LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a mortality benefit. But, the authors and other outside experts warn, the outcome […]
March 15th, 2015
New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors — evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron — were presented at the American College of Cardiology meeting in San Diego and published simultaneously in the New England Journal of Medicine. […]
October 6th, 2014
This week’s topics include medical device safety and effectiveness, familial hypercholesterolemia, and more.
August 31st, 2014
Amid a slew of new data demonstrating yet again that PCSK9 inhibitors lower LDL cholesterol—drastically and in a wide variety of different patient populations—data from one trial offers the first suggestion that the drugs may in fact improve cardiovascular outcomes. But the analysis, the authors cautioned, is a post-hoc analysis of a trial neither designed nor […]
December 10th, 2012
This week’s topics include a comparison of warfarin and new oral anticoagulants for managing AF and VTE, two studies of a monoclonal antibody to PCSK9 in patients with hypercholesterolemia, and more.
October 31st, 2012
When added to low-dose atorvastatin, a much-discussed new monoclonal antibody to PCSK9 significantly lowers cholesterol more effectively than atorvastatin alone, according to a phase 2 study published in the New England Journal of Medicine. Earlier this year, in March, the findings of three phase 1 trials demonstrating the cholesterol-lowering effects of the drug in healthy […]
March 22nd, 2012
Promising results from very early studies with an experimental new cholesterol-lowering drug, a monoclonal antibody to PCSK9, have been published in the New England Journal of Medicine. Evan Stein and colleagues report the results of two single-dose studies in which the drug, REGN727, was administered intravenously or subcutaneously to healthy subjects. In a third, randomized, placebo-controlled, dose-ranging trial, […]