FOURIER-OLE
Trial question
What is the role of long-term use of evolocumab in patients with established ASCVD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 6635
6635 patients (1549 female, 5086 male).
Inclusion criteria: patients with a history of established ASCVD and a fasting LDL-C 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
Composite of CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization
3.36%
3.96%
4.0 %
3.0 %
2.0 %
1.0 %
0.0 %
Evolocumab
Placebo in parent
study
Significant
decrease ▼
NNT = 166
Significant decrease in CV death, MI, 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 CV death, MI or stroke (2.05% vs. 2.58%; HR 0.8, 95% CI 0.68 to 0.93).
Significant decrease in CV death (0.68% vs. 0.9%; HR 0.77, 95% CI 0.6 to 0.99).
Significant decrease in coronary artery disease death or MI (1.3% vs. 1.82%; HR 0.72, 95% CI 0.6 to 0.86).
Safety outcomes
No significant differences in LDL-C 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 LDL-C level ≥ 70 mg/dL while on statin, evolocumab was superior to placebo in parent study with respect to the composite of CV death, MI, 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