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Amgen Announces Evolocumab (AMG 145) Results From First 52-Week Study Of A PCSK9 Inhibitor To Reduce LDL Cholesterol
Date:11/19/2013

ve 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.

"Many patients with high cholesterol struggle to adequately reduce their LDL-C, a significant contributor to cardiovascular disease," said Michael Koren, M.D., of the Jacksonville Center for Clinical Research. "The results from the OSLER study are encouraging as evolocumab may offer a potential treatment option for patients who cannot control their cholesterol levels."

Adverse events occurred in 81.4 percent of patients treated with evolocumab and SOC and in 73.1 percent of the SOC group. The five most common AEs in the evolocumab and SOC group compared to the SOC group were nasopharyngitis (12.2 percent vs. 9.8 percent), upper respiratory tract infections (7.7 percent vs. 7.6 percent), influenza (7.1 percent vs. 5.2 percent), arthralgia (6.9 percent vs. 4.3 percent), and back pain (6.5 percent vs. 5.4 percent). Other AEs that were reported included muscle-related events (9.2 percent vs. 9.8 percent), elevated liver function tests (1.8 percent vs. 1.6 percent), and elevated creatine kinase (1.0 percent vs. 1.9 percent) for patients treated with evolocumab and SOC compared to SOC alone, respectively. Serious AEs occurred in 7.1 percent of patients treated with evolocumab and SOC and 6.3 percent of the SOC group.

In the OSLER clinical trial, subcutaneous monthly treatment with evolocumab in combination with SOC resulted in a significant LDL-C decrease versus SOC alone in patients who previously completed one of four 12-week Phase 2 studies of evolocumab. After 52 weeks of treatment, patients who first received evolocumab in the OSLER study experienced an average of 52 percent reduction in LDL-C, as
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