Secondary analysis
Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE
- Secondary analysis of the FOURIER-OLE open-label extension
- prespecified analysis
- multivariable adjustment
Median follow-up in FOURIER-OLE 5 years (after FOURIER median 2.2 years)
Authors' conclusion
In patients with atherosclerotic cardiovascular disease, long-term achievement of lower LDL-C levels, down to <20 mg/dL (<0.5 mmol/L), was associated with a lower risk of cardiovascular outcomes with no significant safety concerns.
Study context
- Population
- Patients with stable atherosclerotic CVD transitioned to open-label evolocumab in FOURIER-OLE6,559 with achieved low-density lipoprotein cholesterol (LDL-C)
- Participants
- 6,635 patients
- Comparison
- Achieved LDL-C categories
- <20 mg/dLn = 1,604
- 20 to <40 mg/dLn = 2,627
- 40 to <55 mg/dLn = 1,031
- 55 to <70 mg/dLn = 486
- ≥70 mg/dLn = 811reference
- Primary endpoint
- Composite of:
- CV death
- MI
- Stroke
- Hospital admission for unstable angina
- Coronary revascularization
Primary result
As reported in the abstract
Monotonic relationship between lower achieved LDL-C (down to <20 mg/dL) and lower risk, persisting after multivariable adjustment
adjusted Ptrend<0.0001
Secondary outcomes
Key secondary efficacy end point (CV death, MI or stroke) by achieved LDL-C
- Monotonic relationship between lower achieved LDL-C and lower risk, persisting after multivariable adjustment
- adjusted Ptrend<0.0001
Entire FOURIER and FOURIER-OLE cohort (sensitivity analysis) · up to 8.6 years
- Similar findings
Safety
Serious AEs, new or recurrent cancer, cataract-related AEs, hemorrhagic stroke, new-onset DM, neurocognitive AEs, muscle-related events, noncardiovascular death
- No statistically significant association between lower achieved LDL-C and increased risk
Original publication
Summarised from the published abstract; every number is checked against it