Clinical research progress of anti-proprotein convertase subtilisin/kexin type 9 (pcsk9) monoclonal antibodies / 中国药学杂志

ABSTRACT

To summarize the data from clinical trials of anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in patients with hypercholesterolaemia. Based on systematic literature review, theresults of clinical trials of different anti-PCSK9 mAbs were presented and evaluated. In phase I, II, III trials, anti-PCSK9 mAbs resulted in 50%-60% reduction in low-density lipoprotein-cholesterol (LDL-C) level and had a lower incidence of adverse effects, compared with placebo or ezetimibein patients with hypercholesterolaemia. Anti-PCSK9 mAbs have demonstrated a significant effect of reducing LDL-C and were well tolerated in short-term (up to 52 weeks) trials. Large phase III trials are ongoing to evaluate the long-term safety and efficacy as well as the impact of these promising new agents on cardiovascular outcomes.