Adverse effects of statins are relatively common causing poor adherence to treatment and the need for interruption of about 10-20%.The Evolocumab is a fully human monoclonal antibody that inhibits a protein converting subtilisin/ kexin type 9 (PCSK 9); this is a protein that reduces the liver’s ability to remove LDL cholesterol from theblood.This is a study with three branches (evolocumab, ezetimibe and placebo) to test the effectiveness of evolocumab reducing LDL in patients intolerant to at least two statins.Myalgia was the most common side effect (18% in the ezetimibe group and 8 % in the evolocumabgroup). Both the administration (subcutaneously) every 15 days or monthly,evolocumab decreased significantly more LDL cholesterol than ezetimibe.
Conclusion
Both the administration every two weeks as well as monthly produced a potent reduction in LDL cholesterol in patients with intolerance to at least 2 statins and presented a good safety profile with a low incidence of muscle symptoms.
4_erik_stroes_slides
Erik Stroes
2014-03-31
Original title: A Phase 3 Double-blind, Randomized Study to Assess the Safety and Efficacy of Evolocumab (AMG 145) in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of Statin.