Page 9 - SHJ VOL 5, NO 1
P. 9

SHJ Vol 5, No 1                                M Ibrahim, Putting PCSK9 Inhibitors into practice
            proprotein  convertase  subtilisin/kexin  type  9     recommendations  on  the  clinical  utility  of
            (PCSK9)  antibody  therapy  that  were  provided      PCSK9  inhibitors  in  patients  with  stable
            by  the  2015  National  Lipid  Association           ASCVD,      progressive   ASCVD,       familial
            Recommendations  for  the  Patient-Centered           hypercholesterolemia    phenotype/low-density
            Management  of  Dyslipidemia;  current  update        lipoprotein cholesterol  ≥190  mg/dL, and very-
            provides  the  Expert  Panel‘s  evidence-based        high-risk patients with statin intolerance (25).

            (Figure 1)  2017 Recommendations of the NLA Expert Panel on treatment with PCSK9 inhibitors

            Tolerability and safety of pcsk9 inhibitors           evolocumab (26).
            The  PCSK9  inhibitors  appear  to  be  generally     Long-term  safety  data  are  available  from  the
            well-tolerated,  but  long-term  safety  data  are    OSLER  trials  with  evolocumab  (n=4,465,
            needed  as  well  as  long-term  outcomes  studies    median follow-up 11.1 months) and ODYSSEY
            (Table  2).  A  meta-analysis  of  20  randomized     LONG  TERM  with  alirocumab  (n=2,341,  78
            controlled  trials,  further  confirmed  the          week  treatment  duration)  (27,28).  In  both
            significant  effect  of  PCSK9  inhibitors  in        reports,  adverse  events  were  reported  with
            decreasing  LDL-C  with  good  safety  and            similar  frequency  with  the  PCSK9  inhibitor
            tolerability.  The  overall  incidence  of  adverse   compared with the comparator (standard of care
            events was similar with evolocumab or placebo.        in OSLER versus evolocumab, and placebo in
            There  was  a  slight  excess  of  injection  site    ODYSSEY LONG TERM versus alirocumab).
            reactions  and  muscle-related  events  with

   4   5   6   7   8   9   10   11   12   13   14