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 .
A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I.
BACKGROUND AND AIMS In previous phase III studies , the PCSK9 monoclonal antibody alirocumab was administered at doses of 75 or 150 mg every 2 weeks ( Q2W ) . CHOICE I ( NCT01926782 ) evaluated 300 mg every 4 weeks ( Q4W ) in patients on either maximally  tolerated statin  or no statin , both ± other lipid-lowering therapies . METHODS CHOICE I included patients with hypercholesterolemia at moderate-to-very-high cardiovascular risk . Patients were r and omized to alirocumab 300 mg Q4W , 75 mg Q2W ( calibrator arm ) , or placebo for 48 weeks , with dose adjustment for either alirocumab arm to 150 mg Q2W at Week ( W ) 12 if at W8 LDL-C levels were > 70/100 mg/dL ( 1.8/2.6 mmol/L ) depending on cardiovascular risk or LDL-C reduction was < 30 % from baseline . Co- primary endpoints were percent LDL-C change from baseline to W24 , and to time-averaged LDL-C over W21 - 24 . RESULTS Approximately two-thirds of r and omized patients were receiving statins . At W12 , 14.7 % ( no statin ) and 19.3 % ( statin ) of patients receiving alirocumab 300 mg Q4W required dose adjustment . At W24 , significant LDL-C reductions from baseline were observed with alirocumab 300 mg Q4W : mean differences were -52.7 % ( no statin ; placebo : -0.3 % ) and -58.8 % ( statin ; placebo : -0.1 % ) . Average LDL-C reductions from baseline to W21 - 24 were also significantly greater with alirocumab 300 mg Q4W vs. placebo in patients not receiving ( -56.9 % vs. -1.6 % ) and receiving statin ( -65.8 % vs. -0.8 % ) . Treatment-emergent adverse event rates ranged from 61.1 to 75.0 % ( placebo ) and 71.5 to 78.1 % ( alirocumab 300 mg Q4W ) . CONCLUSIONS Alirocumab 300 mg Q4W is a viable additional treatment option in patients requiring LDL-C-lowering
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 .