6/28/23, 11:44 PM ODYSSEY Pathway Feedback Search Clinical Topics Home Studies ODYSSEY ODYSSEY Disease Dyslipidemia Trial question What is the role of alirocumab in patients at high risk for cardiovascular events? Study design Multi-center Double blinded RCT Population Characteristics of study participants 38.0% female N = 2341 62.0% male 2341 patients (884 female, 1457 male) Inclusion criteria: patients at high risk for cardiovascular events who had LDL cholesterol levels 70 mg/dL and were receiving treatment with statins at the maximum tolerated dose, with or without other lipid-lowering therapy Key exclusion criteria: age < 18 years, LDL cholesterol < 70 mg/dL, fasting serum triglycerides > 400 mg/dL Interventions N=1553 alirocumab (150 mg as a single 1 ml subcutaneous injection every 2 weeks for 78 weeks) N=788 placebo (matching placebo as a single 1 ml subcutaneous injection every 2 weeks for 78 weeks) https://web.pathway.md/studies/recsHcBKqpIETbcSY 1/2 6/28/23, 11:44 PM ODYSSEY Pathway Primary outcome Significant decrease in the percentage change in calculated LDL cholesterol level at 24 weeks (-61% vs. 0.8%; ARD -61.9, 95% CI -64.3 to -59.4) Secondary outcomes Significant decrease in the percentage change in calculated LDL cholesterol at 78 weeks (-52.4% vs. 3.6%; ARD -56, 95% CI -59.1 to -52.8) Significant decrease in change in total cholesterol (-37.8% vs. -0.3%; ARD -37.5, 95% CI -39.1 to -35.9) Significant increase in change in HDL cholesterol (4% vs. -0.6%; AD 4.6%, 95% CI 3.3 to 5.9) Safety outcomes No significant difference in any adverse event and adverse event leading to study-drug discontinuation. Significant difference in myalgia (5.4% vs. 2.9%). Conclusion In patients at high risk for cardiovascular events who had LDL cholesterol levels 70 mg/dL and were receiving treatment with statins at the maximum tolerated dose, with or without other lipid- lowering therapy, alirocumab was superior to placebo with respect to the percentage change in calculated LDL cholesterol level at 24 weeks. Reference Robinson JG, Farnier M, Krempf M et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. Open reference URL https://web.pathway.md/studies/recsHcBKqpIETbcSY 2/2