Jul 09, 2025
At the American Diabetes Association (ADA) annual conference held in Chicago, emerging data spotlighted the elevated cardiovascular risk faced by individuals with T1D. Amgen presented an abstract titled “Cardiovascular Efficacy of Evolocumab in Persons with T1D: Insights from the FOURIER Trial,” highlighting the potential benefit of intensive LDL-C lowering in this high-risk population.
Executive Summary
Evolocumab, a PCSK9 inhibitor, has already demonstrated cardiovascular benefits in patients with Atherosclerotic Cardiovascular Disease (ASCVD). The FOURIER trial extends this evidence to individuals with Type 1 Diabetes Mellitus (T1DM), a group with notably elevated cardiovascular risk. The trial suggests that intensive LDL-C lowering with evolocumab, added to optimized statin therapy, offers substantial clinical benefits, especially in the high-risk T1DM subgroup.
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Trial Design
The FOURIER trial (NCT01764633) investigated whether adding evolocumab to statin therapy improves cardiovascular outcomes in patients with ASCVD, including subgroups with no diabetes, T2DM, and T1DM. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
Results
Conclusion
The cardiovascular burden in T1DM patients remains substantially high, and conventional statin therapy may not fully mitigate this risk. The FOURIER trial indicates that adding evolocumab offers meaningful additional protection, with the highest absolute benefit observed in T1DM despite their small representation.
Future Outlook
While the data are promising, larger, T1DM-specific trials are needed to validate these observations with adequate statistical power. Meanwhile, clinicians may consider evolocumab for high-risk T1DM patients with ASCVD who remain above LDL-C goals on statins alone. The evolving role of PCSK9 inhibitors in diabetes-associated ASCVD risk management holds considerable promise.
Article in PDF
Jul 09, 2025
At the American Diabetes Association (ADA) annual conference held in Chicago, emerging data spotlighted the elevated cardiovascular risk faced by individuals with T1D. Amgen presented an abstract titled “Cardiovascular Efficacy of Evolocumab in Persons with T1D: Insights from the FOURIER Trial,” highlighting the potential benefit of intensive LDL-C lowering in this high-risk population.
Executive Summary
Evolocumab, a PCSK9 inhibitor, has already demonstrated cardiovascular benefits in patients with Atherosclerotic Cardiovascular Disease (ASCVD). The FOURIER trial extends this evidence to individuals with Type 1 Diabetes Mellitus (T1DM), a group with notably elevated cardiovascular risk. The trial suggests that intensive LDL-C lowering with evolocumab, added to optimized statin therapy, offers substantial clinical benefits, especially in the high-risk T1DM subgroup.
Trial Design
The FOURIER trial (NCT01764633) investigated whether adding evolocumab to statin therapy improves cardiovascular outcomes in patients with ASCVD, including subgroups with no diabetes, T2DM, and T1DM. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
Results
Conclusion
The cardiovascular burden in T1DM patients remains substantially high, and conventional statin therapy may not fully mitigate this risk. The FOURIER trial indicates that adding evolocumab offers meaningful additional protection, with the highest absolute benefit observed in T1DM despite their small representation.
Future Outlook
While the data are promising, larger, T1DM-specific trials are needed to validate these observations with adequate statistical power. Meanwhile, clinicians may consider evolocumab for high-risk T1DM patients with ASCVD who remain above LDL-C goals on statins alone. The evolving role of PCSK9 inhibitors in diabetes-associated ASCVD risk management holds considerable promise.