Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes .
Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab .
Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study
Background The PCSK9 antibody alirocumab ( 75 mg every 2 weeks ; Q2W ) as monotherapy reduced low‐density lipoprotein‐cholesterol ( LDL‐C ) levels by 47 % . Because the option of a monthly dosing regimen is convenient , ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin ( majority with statin‐associated muscle symptoms ) , receiving treatment with fenofibrate , ezetimibe , or diet alone . Methods and Results Patients were r and omly assigned to placebo , alirocumab 150 mg Q4W or 75 mg Q2W ( calibrator arm ) , with dose adjustment to 150 mg Q2W at week ( W ) 12 if W8 predefined LDL‐C target levels were not met . The primary efficacy endpoint was LDL‐C percentage change from baseline to W24 . Mean baseline LDL‐C levels were 163.9 mg/dL ( alirocumab 150 mg Q4W , n=59 ) , 154.5 mg/dL ( alirocumab 75 mg Q2W , n=116 ) , and 158.5 mg/dL ( placebo , n=58 ) . In the alirocumab 150 mg Q4W and 75 mg Q2W groups ( 49.1 % and 36.0 % of patients received dose adjustment , respectively ) , least‐squares mean LDL‐C changes from baseline to W24 were −51.7 % and −53.5 % , respectively ( placebo [ + 4.7 % ] ; both groups P<0.0001 versus placebo ) . In total , 63.9 % and 70.3 % of alirocumab‐treated patients achieved their LDL‐C targets at W24 . Treatment‐emergent adverse events occurred in 77.6 % ( alirocumab 150 mg Q4W ) , 73.0 % ( alirocumab 75 mg Q2W ) , and 63.8 % ( placebo ) of patients , with injection‐site reactions among the most common treatment‐emergent adverse events . Conclusions Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL‐C. Clinical Trial Registration URL : http://www . clinical trials.gov . Unique identifier : NCT02023879
Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes .
Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab .