THOUSAND OAKS, Calif., Nov. 19, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from the Open Label Study of Long T ERm 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 1, 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.
According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C. 2 Elevated LDL-C is recognized as a major risk factor for cardiovascular (CV) disease, which is the number one cause of death worldwide, claiming more lives each year than cancer, chronic lower respiratory disease and accidents combined. 3-5
"Phase 2 findings from OSLER, the first reported 52-week evaluation of a PCSK9 inhibitor, are encouraging and suggest evolocumab may be a promising option to treat hyperlipidemia in a range of at-risk patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to Phase 3 results from our PROFICIO clinical program evaluating the safety and efficacy of two distinctive dosing options of evolocumab in a range of at-risk patient populations."
OSLER is an ongoing open-label extension study evaluating the long-term safety and efficacy of evolocumab in patients with high cholesterol. In the first year, patients were randomized 2:1 to receive evolocumab and SOC or SOC alone.
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