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 .
Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins　- ODYSSEY JAPAN Randomized Controlled Trial.
BACKGROUND The ODYSSEY Japan study was design ed to demonstrate the reduction in low-density lipoprotein cholesterol ( LDL-C )  by alirocumab as add-on to existing lipid-lowering therapy in Japanese patients with heterozygous familial hypercholesterolemia ( heFH ) or non-FH at high cardiovascular risk who require additional pharmacological management to achieve their LDL-C treatment goal ( < 2.6 or < 3.1 mmol/L , depending on risk category ) . METHODS AND RESULTS This r and omized , double-blind , parallel-group , 52-week study was conducted in Japan . Patients ( n=216 ) with heFH , non-FH at high cardiovascular risk with coronary disease , or classified as category III were enrolled . The prespecified safety analysis was done after the last patient completed 52 weeks . Patients were r and omized ( 2:1 , alirocumab : placebo ) with stratification for heFH to s.c . alirocumab ( 75 mg every 2 weeks [ Q2 W ] with increase to 150 mg if week 8 LDL-C ≥2.6/3.1 mmol/L ) or placebo for 52 weeks plus stable statin therapy . At week 24 , mean±SE change in LDL-C from baseline was -62.5±1.3 % in the alirocumab group and 1.6±1.8 % in the placebo group ( difference , -64.1±2.2 % ; P<0.0001 ) ; the reduction was sustained to week 52 ( alirocumab , -62.5±1.4 % ; placebo , -3.6±1.9 % ) . No patterns were evident between treatment groups for adverse events at 52 weeks . CONCLUSIONS In high-risk Japanese patients with hypercholesterolemia on stable statin therapy , alirocumab markedly reduced LDL-C vs. placebo and was well tolerated over 52 weeks . ( Circ J 2016 ; 80 : 1980 - 1987 )
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 .