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Preliminary study of PCSK9 inhibitor safety and cardiovascular outcomes
Less than a decade ago, it was first recognized that individuals with certain polymorphisms of the gene proprotein convertase subtilisin-kexin type 9 (PCSK9) had extremely low levels of LDL cholesterol and a low lifetime risk of cardiovascular events. This finding led, in a short space of time, to the development and testing of biological inhibitors of PCSK9 that have been shown to reduce LDL cholesterol in addition to standard therapy. Although a great deal of anticipation surrounds PCSK inhibitors, their safety profile and efficacy in reducing cardiovascular events remains unknown. In this open label extension study of 12 phase II studies of the PCSK9 inhibitor evolocumab, individuals who had already completed and tolerated a course of treatment with evolocumab were randomized in a 2:1 fashion to receive ongoing evolocumab in addition to standard …