AMG 145 (Amgen) success in lowering LDL in OSLER trial

Amgen announced results from the Open Label Study of Long TERm Evaluation Against LDL-C (OSLER) trial , a long-term controlled 52-week safety and efficacy study, that showed monthly treatment with evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood, was not associated with a major increase in adverse events (AEs) versus standard of care (SOC) and produced mean LDL-C reductions of 52 percent in combination with SOC in patients with high cholesterol. These data from the first 52-week study of a PCSK9 inhibitor were presented for the first time today in a Clinical Science: Special Reports session at the American Heart Association (AHA) Scientific Sessions 2013 in Dallas and simultaneously published in Circulation.

See-"Efficacy and Safety of Longer-Term Administration of Evolocumab (AMG 145) in Patients With Hypercholesterolemia- 52-Week Results From the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) Randomized Trial"- Michael J. Koren, MD; Robert P. Giugliano, MD et al.;CIRCULATION AHA.113.007012 Published online before print November 19, 2013, doi: 10.1161/CIRCULATION AHA.113.007012