UNASSIGNED: Evolocumab (AMG 145), a fully human monoclonal antibody against @entity756 , significantly reduced low-density lipoprotein @entity165 ( @entity11429 ) levels in phase 2 and 3 studies. This phase 3 study evaluated the efficacy and safety of evolocumab plus @entity2993 in Japanese @entity1 with @entity407 or mixed @entity2299 and high cardiovascular risk. @entity1 were randomized to @entity2993 5 or 20  mg/day for 4  weeks. Subsequently, @entity1 underwent second randomization to evolocumab 140  mg biweekly ( @entity15724 ) or 420  mg monthly (QM) or placebo Q2W or QM. Coprimary end points were % change from baseline in @entity11429 at week 12 and mean of weeks 10 and 12. Secondary end points included change and % change in other lipids and proportion of @entity1 reaching @entity11429 <70  mg/dl. Adverse events and laboratory values were recorded. Four hundred four @entity1 were randomized to study drug. At baseline, the mean (SD) age was 61 (10) years (placebo) and 62 (11) years (evolocumab); 39% and 40% were @entity1 ; 14% and 12% had cerebrovascular or peripheral @entity455 ; and 51% and 47% had @entity6 . At entry, mean (SD) calculated @entity11429 was 128 (23) mg/dL; after stabilization on @entity2993 5 and 20  mg/day, baseline @entity11429 levels were 118 (35) and 94 (24) mg/dL, respectively. Mean @entity11429 reductions at week 12 for evolocumab versus placebo ranged from 67% to 76%. No imbalances were observed in adverse events between treatment groups. Efficacy and safety for Q2W or QM evolocumab dosing were similar. In conclusion, in high-risk Japanese @entity1 receiving stable statin therapy, evolocumab markedly reduced @entity11429 and was well tolerated.

A Phase 3 Study of Evolocumab (AMG 145) in Statin-Treated Japanese XXXX at High Cardiovascular Risk.

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients'] @entity407 :: ('MESH:D006949', 'Disease') :: ['hyperlipidemia'] @entity455 :: ('MESH:D014652', 'Disease') :: ['arterial disease'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity756 :: ('255738', 'Gene') :: ['PCSK9'] @entity2299 :: ('MESH:D050171', 'Disease') :: ['dyslipidemia'] @entity2993 :: ('MESH:C065179', 'Chemical') :: ['atorvastatin'] @entity15724 :: ('p|SUB|Q|2|W', 'ProteinMutation') :: ['Q2W'] @entity11429 :: ('22796', 'Gene') :: ['LDL-C'] @entity165 :: ('MESH:D002784', 'Chemical') :: ['cholesterol']
@entity1 :: (9606,Species) :: ['Patients']
