FOURIER
Trial question
What is the role of evolocumab in patients with ASCVD and LDL cholesterol levels ≥ 70 mg/dL who were receiving statin therapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 27564
27564 patients (6769 female, 20795 male).
Inclusion criteria: patients with ASCVD and LDL cholesterol ≥ 70 mg/dL (1.8 mmol/L) who were receiving statin therapy.
Key exclusion criteria: known hemorrhagic stroke; uncontrolled or recurrent VT; uncontrolled hypertension; planned or expected cardiac surgery or revascularization within 3 months; severe renal dysfunction; pregnancy or lactation.
Interventions
N=13784 evolocumab (either 140 mg every 2 weeks or 420 mg monthly SC).
N=13780 placebo (subcutaneous injections).
Primary outcome
Major CV events
9.8%
11.3%
11.3 %
8.5 %
5.7 %
2.8 %
0.0 %
Evolocumab
Placebo
Significant
decrease ▼
NNT = 66
Significant decrease in major CV events (9.8% vs. 11.3%; HR 0.85, 95% CI 0.79 to 0.92).
Secondary outcomes
Significant decrease in CV death, MI, or stroke (5.9% vs. 7.4%; HR 0.8, 95% CI 0.73 to 0.88).
Safety outcomes
No significant differences in overall adverse events, with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%).
Conclusion
In patients with ASCVD and LDL cholesterol ≥ 70 mg/dL (1.8 mmol/L) who were receiving statin therapy, evolocumab was superior to placebo with respect to major CV events.
Reference
Marc S Sabatine, Robert P Giugliano, Anthony C Keech et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722.
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