title: Is there enough evidence with evolocumab and alirocumab (antibodies to proprotein convertase substilisin-kexin type, PCSK9) on cardiovascular outcomes to use them widely? Evaluation of Sabatine MS, Giugliano RP, Wiviott SD et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1500-1509, and Robinson JG, Farnier M, Krempf M et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1488-99.
abstract: BACKGROUND
  Statins alone often do not reduce LDL cholesterol levels sufficiently to given maximum cardiovascular benefit. Thus, additional drugs are required to reduce the levels of LDL cholesterol. Monoclonal antibodies to PCSK9 have recently been shown to decrease LDL cholesterol, but it is not known whether they improve cardiovascular outcomes.
  
  
  METHODS
  We evaluated two clinical trials reporting cardiovascular outcomes with antibodies to PCSK9, the OSLER extension with evolocumab, and the ODYSSEY LONG TERM trial with alirocumab.
  
  
  CONCLUSIONS
  In OSLER and ODYSSEY LONG TERM, there were very few cardiovascular outcomes, but the trials do suggest that evolocumab and alirocumab may reduce these outcomes. However, there are also some safety concerns with both of these antibodies. Large clinical outcome trials are underway with both evolocumab and alirocumab, which will probably clarify both the safety concerns and any cardiovascular benefits with these antibodies. In our opinion, these antibodies may be suitable for use in subjects with familial hypercholesterolemia, who are uncontrolled with their present medications, provided intensive safety and cardiovascular monitoring is being undertaken. However, evolocumab and alirocumab should be used with caution in other subjects, until outcome studies in higher numbers of subjects have shown acceptable safety and cardiovascular profiles.
authors.affiliation: a 1 Queensland University of Technology , Brisbane, Australia sheila.doggrell@qut.edu.au.
authors.forename: Sheila Anne
authors.initials: SA
authors.lastname: Doggrell
authors.affiliation: b 2 Queensland University of Technology , Brisbane, Australia.
authors.forename: Kaileen Anne
authors.initials: KA
authors.lastname: Lynch
keywords: LDL cholesterol; PCSK9 antibodies; alirocumab; cardiovascular events; evolocumab; safety