부산대학교 도서관

Introduction: Eight ODYSSEY Phase 3 trials allowed for alirocumab dose increase at Week 12 for patients who did not achieve pre-specified LDL cholesterol (LDL-C) levels at Week 8.Objective: To analyze baseline factors associated with > median versus ≤ median LDL-C response to alirocumab dose increase.Methods: Alirocumab-treated patients who did not achieve a pre-specified LDL-C level at Week 8 (<70 mg/dL for COMBO I/II, FH I/II, and MONO trials, or <70 mg/dL with prior cardiovascular events or <100 mg/dL with other risk factors for OPTIONS I/II and ALTERNATIVE trials) received blinded dose increase from 75 to 150 mg once every 2 weeks at Week 12 during these eight placebo- or ezetimibe-controlled ODYSSEY Phase 3 trials, and were included in this analysis. Univariate regression analysis was conducted to evaluate the impact of baseline factors on the magnitude of response to alirocumab dose increase.Results: Of the 1446 patients that participated in the eight trials, 408 (28.2%) received alirocumab dose increase at Week 12 and are included in this analysis. Median reduction in LDL-C from baseline to Week 24 was 56.2%. Baseline factors examined in relation to the magnitude of response to alirocumab dose increase are shown in the Table. The 95% CI associated with odds ratios for comparing baseline characteristics between those with > median versus ≤ median LDL-C response groups included 1 for all except total and free PCSK9, which did not contain 1 (Table). Rates of adverse events were 80.4% versus 75.1% in patients achieving > median versus ≤ median LDL-C response at Week 24, respectively.Conclusions: In this analysis, no particular baseline characteristic was strongly associated with > or ≤ median reduction in LDL-C in patients with an alirocumab dose increase.