There are several patients who do not reach recommended LDL cholesterol despite maximally tolerated doses of statins levels.The Evolocumab is a monoclonal antibody that inhibits protein converting subtilisin / kexin type 9 (PCSK9) showed lowering LDL cholesterol in phase 2 studies.
The objective of this Phase 3 study was to evaluate the safety and efficacy of subcutaneous administration of Evolocumab for 12 weeks in combination with statins in patients with hypercholesterolemia or mixed dyslipidemia and also compare their performance with ezetimibe.1896 patients were randomized to receive the study drug once a month or every two weeks with a placebo controlled group and an ezetimibe group, showing a reduction of between 63 and 75% with Evolocumab relative to placebo. Ezetimibe made a reduction of between 19 and 32% compared with placebo.
Conclusion
The Evolocumab significantly reduces LDL by 10-12 weeks associated with a statin. Both dosage regimens were clinically equivalent and no differences in the safety profile and tolerance between treatment groups.
Jennifer G Robinson
2014-03-31
Original title: The Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy – 2 Trial: A Phase 3, Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia (LAPLACE-2 Trial).
