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
Sabatine MS, Giugliano RP, Keech AC 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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