Evolocumab promising in patients who cannot tolerate statins

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (GAUSS)

News - Apr. 1, 2014

Presented at the 2014 Scientific Sessions by: Prof. Erik Stroes (Amsterdam, The Netherlands)


Reducing LDL-c levels to lower the risk of cardiovascular disease can largely be achieved with statins. This treatment is, however, not appropriate for all patients, because some may not tolerate statins well.
AMG 145 or evolocumab is a fully human monoclonal antibody against PCSK9, and is a new therapeutic option to lower LDL-c levels. In a phase 2 study evolocumab reduced LDL-c in patients who could not tolerate at least one statin. To date, no appropriate treatment was available for this treatment group.
In this randomised, multicenter study, the efficacy with regard to LDL-c lowering and the tolerability of 12 weeks of treatment with evolocumab was evaluated, in comparison with ezetimibe, in hypercholesterolaemic participants who cannot tolerate effective doses of statins.

Main results

  • After 12 weeks of treatment LDL-c was reduced with on average 56% in the group who received biweekly evolocumab140 mg (n=103), while on average 18% reduction was seen in the ezetimibe group (n=51), as compared to baseline.
  • Monthly administration of evolocumab 420 mg gave 53% reduction of LDL-c after 12 weeks (n=102), as compared to 15% reduction with ezetimibe (n=51).
  • The biweekly and monthly dosing schemes gave clinically equivalent and statistically significant treatment effects in comparison with ezetimibe, at the end of the study.
  • Significantly more people who received evolocumab (both dosing schemes) achieved the target LDL-c level appropriate for either a low, moderate or high CV risk 12 weeks.
  • Evolocumab was generally well tolerated, and adverse effects were mostly mild. 17 of 205 patients (8%) discontinued evolocumab due to adverse effects, while 13 of 105 (13%) of patients on ezetimibe stopped taking the study drug.
  • Muscle symptoms were rare. Myalgia was reported in 18/102 (18%) patients on ezetimibe and in 16/205 (8%) of patients on evolocumab.


Evolocumab gave a potent reduction of LDL-c levels after 12 weeks of treatment of patients who cannot tolerate statins. Biweekly or monthly administration gave a clinically equivalent effect. Because the agent was well tolerated, evolocumab is a promising option to treat hypercholesterolaemic patients who cannot tolerate statins.

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