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 .
Randomised study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Primary results of the BERSON clinical trial
Aim To evaluate the lipid‐lowering efficacy and safety of evolocumab combined with background atorvastatin in patients with type 2 diabetes mellitus ( T2DM ) and hyperlipidaemia or mixed dyslipidaemia . Material s and methods BERSON was a double‐blind , 12‐week , phase 3 study ( NCT02662569 ) conducted in 10 countries . Patients ≥18 to ≤80 years with type T2DM received atorvastatin 20 mg/d and were r and omised 2:2:1:1 to evolocumab 140 mg every 2 weeks ( Q2W ) or 420 mg monthly ( QM ) or placebo Q2W or QM . Co‐ primary endpoints were the percentage change in low‐density lipoprotein cholesterol ( LDL‐C ) from baseline to week 12 and from baseline to the mean of weeks 10 and 12 . Additional endpoints included atherogenic lipids , glycaemic measures , and adverse events ( AEs ) . Results Overall , 981 patients were r and omised and received ≥1 dose of study drug . Evolocumab significantly reduced LDL‐C  versus placebo at week 12 ( Q2W , −71.8 % ; QM , −74.9 % ) and at the mean of weeks 10 and 12 ( Q2W , −70.3 % ; QM , −70.0 % ; adjusted P < 0.0001 for all ) when administered with atorvastatin . Non‐high‐density lipoprotein cholesterol , apolipoprotein B100 , total cholesterol , lipoprotein ( a ) , triglycerides , high‐density lipoprotein cholesterol , and very low‐density lipoprotein cholesterol improved significantly with evolocumab versus placebo . The overall incidence of AEs was similar between evolocumab and placebo‐treated patients , and there were no clinical ly meaningful differences in changes over time in glycaemic variables ( fasting serum glucose and HbA1c ) between the two groups . Conclusions In patients with T2DM and hyperlipidaemia or mixed dyslipidaemia on statin , evolocumab  significantly reduced LDL‐C and other atherogenic lipids , was well tolerated , and had no notable impact on glycaemic measures
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 .