6/28/23, 10:40 PM FOURIER-OLE Pathway Feedback Search Clinical Topics Home Studies FOURIER OLE FOURIER OLE Disease Disease Coronary artery disease Dyslipidemia Trial question What is the role of long-term use of evolocumab in patients with established ASCVD? Study design Multi-center Open label RCT Population Characteristics of study participants 23.0% female N = 6635 77.0% male 6635 patients (1549 female, 5086 male) Inclusion criteria: patients with a history of established ASCVD and a fasting low-density lipoprotein cholesterol level 70 mg/dL while on statin Key exclusion criteria: permanent medication discontinual due to adverse effects in the parent study; participation in another study; not being able to complete follow-up for the duration of the extension program; pregnancy Interventions N=3355 evolocumab (continuous receipt, from FOURIER study, of subcutaneous injections of either 140 mg every 2 weeks or 420 mg every month) N=3280 placebo in parent study (receipt of placebo in parent study and evolocumab in this extension study) Primary outcome https://web.pathway.md/studies/recN2ZXdvdYnS5dqB 1/2 6/28/23, 10:40 PM FOURIER-OLE Pathway Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization 4.0 % 3.96 3.36 3.0 % 2.0 % Significant decrease 1.0 % NNT = 167 0.0 % Evolocumab Placebo in parent study Significant decrease in composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (3.36% vs. 3.96%; HR 0.85, 95% CI 0.75 to 0.96) Secondary outcomes Significant decrease in cardiovascular death, myocardial infarction or stroke (2.05% vs. 2.58%; HR 0.8, 95% CI 0.68 to 0.93) Significant decrease in cardiovascular death (0.68% vs. 0.9%; HR 0.77, 95% CI 0.6 to 0.99) Significant decrease in coronary heart disease death or myocardial infarction (1.3% vs. 1.82%; HR 0.72, 95% CI 0.6 to 0.86) Safety outcomes No significant differences in low-density lipoprotein cholesterol levels, adverse events. Significant difference in injection site reactions (0.81% vs. 0.65%). Conclusion In patients with a history of established ASCVD and a fasting low-density lipoprotein cholesterol level 70 mg/dL while on statin, evolocumab was superior to placebo in parent study with respect to the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. Reference Michelle L O'Donoghue, Robert P Giugliano, Stephen D Wiviott et al. Long-Term Evolocumab in Patients with Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. Open reference URL https://web.pathway.md/studies/recN2ZXdvdYnS5dqB 2/2