The reduction in MACEs was observed in White but not in Asian subjects .
Both alirocumab and evolocumab are well tolerated and can greatly improve lipid profiles for patients at high cardiovascular risk .
Both PCSK9 monoclonal antibodies significantly reduce the risk of nonfatal MACEs in patients with previous cardiovascular events , but the effect on all-cause mortality remains uncertain
Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies are powerful lipid-lowering drugs which have been shown to improve clinical endpoints in patients with hypercholesterolemia .
However , it is not clear how effective PCSK9 monoclonal antibodies are for patients at high cardiovascular risk .
Also , whether the effectiveness of PCSK9 monoclonal antibodies varies between different drug types , dosages , race , and indications for PCSK9 monoclonal antibodies remains unclear .
Therefore , we used recently published studies to systematic ally evaluate the efficacy and safety of PCSK9 monoclonal antibodies by analyzing the lipid profiles , adverse events , and clinical endpoints in patients at high cardiovascular risk .
A Phase 3 Study of Evolocumab (AMG 145) in Statin-Treated Japanese Patients at High Cardiovascular Risk.
Evolocumab ( AMG 145 ) , a fully human monoclonal antibody against PCSK9 , significantly reduced low-density lipoprotein cholesterol ( LDL-C ) levels in phase 2 and 3 studies . This phase 3 study evaluated the efficacy and safety of evolocumab plus atorvastatin in Japanese patients with hyperlipidemia or mixed dyslipidemia and high cardiovascular risk . Patients were r and omized to atorvastatin 5 or 20 mg/day for 4 weeks . Subsequently , patients underwent second r and omization to evolocumab 140 mg biweekly ( Q2W ) or 420 mg monthly ( QM ) or placebo Q2W or QM . Co primary end points were % change from baseline in LDL-C at week 12 and mean of weeks 10 and 12 . Secondary end points included change and % change in other lipids and proportion of patients reaching LDL-C < 70 mg/dl . Adverse events and laboratory values were recorded . Four hundred four patients were r and omized to study drug . At baseline , the mean ( SD ) age was 61 ( 10 ) years ( placebo ) and 62 ( 11 ) years ( evolocumab ) ; 39 % and 40 % were women ; 14 % and 12 % had cerebrovascular or peripheral arterial disease ; and 51 % and 47 % had diabetes . At entry , mean ( SD ) calculated LDL-C was 128 ( 23 ) mg/dL ; after stabilization on atorvastatin 5 and 20 mg/day , baseline LDL-C levels were 118 ( 35 ) and 94 ( 24 ) mg/dL , respectively . Mean LDL-C 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 patients receiving stable statin therapy  , evolocumab markedly reduced LDL-C and was well tolerated
The reduction in MACEs was observed in White but not in Asian subjects .
Both alirocumab and evolocumab are well tolerated and can greatly improve lipid profiles for patients at high cardiovascular risk .
Both PCSK9 monoclonal antibodies significantly reduce the risk of nonfatal MACEs in patients with previous cardiovascular events , but the effect on all-cause mortality remains uncertain
Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies are powerful lipid-lowering drugs which have been shown to improve clinical endpoints in patients with hypercholesterolemia .
However , it is not clear how effective PCSK9 monoclonal antibodies are for patients at high cardiovascular risk .
Also , whether the effectiveness of PCSK9 monoclonal antibodies varies between different drug types , dosages , race , and indications for PCSK9 monoclonal antibodies remains unclear .
Therefore , we used recently published studies to systematic ally evaluate the efficacy and safety of PCSK9 monoclonal antibodies by analyzing the lipid profiles , adverse events , and clinical endpoints in patients at high cardiovascular risk .