April 27th, 2015
More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes
Larry Husten, PHD
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
More Information Emerges About the PCSK9 Inhibitors
Larry Husten, PHD
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
Selections from Richard Lehman’s Literature Review: October 6th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include medical device safety and effectiveness, familial hypercholesterolemia, and more.
August 31st, 2014
Preliminary Outcomes Results For PCSK9 Inhibitor
Larry Husten, PHD
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
Selections from Richard Lehman’s Literature Review: December 10th
Richard Lehman, BM, BCh, MRCGP
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
PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect of Atorvastatin
Larry Husten, PHD
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 Phase 1 Results for New Monoclonal Antibody to PCSK9
Larry Husten, PHD
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, […]