Efficacy and safety of the PCSK9 inhibitor alirocumab 300 mg every 4 weeks in patients with ASCVD
AAPA ePoster library. Guerra P. 05/17/17; 180518; 150
Patricia Guerra
Patricia Guerra
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Abstract
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Purpose: Very high risk patients with atherosclerotic cardiovascular disease (ASCVD), low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL at baseline and < 50% LDL-C reduction with maximally tolerated statin may benefit from an additional lipid-lowering agent. The 2016 American College of Cardiology (ACC) Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk recommends that therapy with proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors may be reasonable to consider. The PCSK9 inhibitor alirocumab has been approved by the US Food and Drug Administration and is indicated as adjunct to diet and maximally tolerated statin therapy for treatment of patients with clinical ASCVD or heterozygous familial hypercholesterolemia, who require additional LDL-C lowering. This analysis examined the efficacy and safety of alirocumab in the ODYSSEY CHOICE I study (NCT01926782) using a subgroup of patients with ASCVD on either maximally tolerated statin or no statin (± additional lipid-lowering therapies). Methodology: In CHOICE I, patients received alirocumab 300 mg every 4 weeks (Q4W; n=458), 75 mg every 2 weeks (Q2W; n=115) or placebo (n=229) for 48 weeks, with possible alirocumab dose adjustment to 150 mg Q2W at Week 12 if Week 8 LDL-C levels were >70 mg/dL (for patients with high and very high cardiovascular risk, including ASCVD) or >100 mg/dL (for patients with moderate cardiovascular risk), or if LDL-C reduction from baseline was < 30%. Approximately 2/3 of randomized patients were on statin. The primary efficacy endpoint was LDL-C percentage change from baseline to Week 24. This analysis focused on 390 randomized patients with ASCVD (alirocumab 300 mg Q4W: n=225; alirocumab 75 mg Q2W: n=55; placebo: n=110). Results: In the ASCVD population, mean age was 57.6–67.5 years in patients on statin (n=339) and no statin (n=51). In the CHOICE I study as a whole, the mean age was similar (59.2–61.6 years) (statin: n=547; no statin: n=256). In this analysis of patients with ASCVD, significant LDL-C reductions from baseline were observed from the first lipid analysis at Week 4 (with statin: 57.2%; no statin: 58.0%) and maintained throughout the treatment period in the alirocumab 300 mg Q4W group (alirocumab 75 mg Q2W: 55.8% [statin] and 47.3% [no statin]). At Week 24 (i.e. after possible Week 12 dose adjustment to 150 mg Q2W), significant LDL-C red...
Purpose: Very high risk patients with atherosclerotic cardiovascular disease (ASCVD), low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL at baseline and < 50% LDL-C reduction with maximally tolerated statin may benefit from an additional lipid-lowering agent. The 2016 American College of Cardiology (ACC) Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk recommends that therapy with proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors may be reasonable to consider. The PCSK9 inhibitor alirocumab has been approved by the US Food and Drug Administration and is indicated as adjunct to diet and maximally tolerated statin therapy for treatment of patients with clinical ASCVD or heterozygous familial hypercholesterolemia, who require additional LDL-C lowering. This analysis examined the efficacy and safety of alirocumab in the ODYSSEY CHOICE I study (NCT01926782) using a subgroup of patients with ASCVD on either maximally tolerated statin or no statin (± additional lipid-lowering therapies). Methodology: In CHOICE I, patients received alirocumab 300 mg every 4 weeks (Q4W; n=458), 75 mg every 2 weeks (Q2W; n=115) or placebo (n=229) for 48 weeks, with possible alirocumab dose adjustment to 150 mg Q2W at Week 12 if Week 8 LDL-C levels were >70 mg/dL (for patients with high and very high cardiovascular risk, including ASCVD) or >100 mg/dL (for patients with moderate cardiovascular risk), or if LDL-C reduction from baseline was < 30%. Approximately 2/3 of randomized patients were on statin. The primary efficacy endpoint was LDL-C percentage change from baseline to Week 24. This analysis focused on 390 randomized patients with ASCVD (alirocumab 300 mg Q4W: n=225; alirocumab 75 mg Q2W: n=55; placebo: n=110). Results: In the ASCVD population, mean age was 57.6–67.5 years in patients on statin (n=339) and no statin (n=51). In the CHOICE I study as a whole, the mean age was similar (59.2–61.6 years) (statin: n=547; no statin: n=256). In this analysis of patients with ASCVD, significant LDL-C reductions from baseline were observed from the first lipid analysis at Week 4 (with statin: 57.2%; no statin: 58.0%) and maintained throughout the treatment period in the alirocumab 300 mg Q4W group (alirocumab 75 mg Q2W: 55.8% [statin] and 47.3% [no statin]). At Week 24 (i.e. after possible Week 12 dose adjustment to 150 mg Q2W), significant LDL-C red...
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