A safety evaluation of evolocumab

ABSTRACTIntroduction: Evolocumabis an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/ kexintype 9 ( PCSK9) inhibitors. The PCSK9inhibitors are the most significant advance in lipid therapy since the introduction of the first statin 30 years ago.Areas covered: The PCSK9monoclonal antibodies have demonstrated a consistently high LDL-C lowering efficacy with and without statins and/or other lipid lowering therapies (LLT). LDL-C levels achieved with these agents are lower than has ever been possible before. This review will focus on the overall safety of evolocumabincluding cognitive impairment, very low LDL-C levels, new onset diabetes and glucose abnormalities, effect on vitamin E and steroid hormones, liver and muscle abnormalities, and immunogenicity and injection site reactions. The phase II and III clinical trials had relatively low patient-years of exposure, but the op...