Cardiovascular Outcomes and Efficacy of the PCSK9 Inhibitor Evolocumab in Individuals With Type 1 Diabetes: Insights From the FOURIER Trial
Authors' conclusion
Intensive LDL-C lowering may provide substantial clinical benefit in individuals with T1DM and ASCVD. Additional randomized controlled cardiovascular outcomes trials are needed in this population.
Study context
- Population
- Participants with atherosclerotic CVD on statins; 10,834 (39.3%) with T2D, 197 (0.7%) with T1D
- Participants
- 27,564 participants
- Comparison
- Evolocumab vs placebo, by diabetes status
- Primary endpoint
- CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization
- Follow-up
- Median 2.2 years
Methodological detailssubgroup analysis by diabetes status
- Subgroup analysis by diabetes status
Primary result
As reported in the abstract
PEP by diabetes status
Evolocumab vs PlaceboHazard ratio (95% CI)
No diabetes; absolute risk reduction 1.3%
0.87(0.79–0.96)
T2D; absolute risk reduction 2.5%
0.84(0.75–0.93)
T1D; absolute risk reduction 7.3%
0.66(0.32–1.38)
Further findings
2.5-year primary end point (PEP) Kaplan-Meier rate in placebo arm by diabetes status
- No diabetes
- 11.0%
- T2D
- 15.2%
- T1D
- 20.4%
- Stepwise increase
- P < 0.0001
Original publication
Cardiovascular Outcomes and Efficacy of the PCSK9 Inhibitor Evolocumab in Individuals With Type 1 Diabetes: Insights From the FOURIER Trial. Diabetes Care. Published 22 June 2025. doi:10.
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