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Evolocumab Associated with Lower Long-term Cardiovascular Event Risk in Real-world Study of More Than 110 000 Patients
New data reveals evolocumab significantly reduces long-term major cardiovascular event risks in ASCVD patients, enhancing treatment strategies for better outcomes.
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New real-world data from the REPATHA-CE study suggest that evolocumab (Repatha®) is associated with significantly lower long-term risk of major adverse cardiovascular events (MACE) among adults with established atherosclerotic cardiovascular disease (ASCVD). Target RWE presented the findings earlier this month at the American Heart Association Scientific Sessions.
The analysis, which included more than 110 000 US patients, represents the largest real-world comparative effectiveness evaluation of evolocumab in ASCVD to date, according to the company.
Lower 4-year MACE Risk with Evolocumab
Investigators reported that treatment with evolocumab was associated with a 20% lower relative risk of a composite MACE outcome of myocardial infarction (MI), stroke, and coronary revascularization (RR = 0.80; 95% CI, 0.73-0.86) at 4 years compared with no evolocumab treatment.
A second composite outcome that included MI, stroke, and cardiovascular death showed a 29% lower relative risk (RR = 0.71; 95% CI, 0.64-0.78).
The study included 87 102 evolocumab-treated and 24 609 untreated patients with ASCVD identified between 2017 and 2023 from Komodo’s Healthcare Map®, a dataset representing health care encounters from more than 330 million deidentified US patients.
Study Details and Context
The REPATHA-CE study was conducted by Target RWE in collaboration with Amgen and used Target RWE’s causalStudio™ software platform. Results were presented in the abstract “Real-World Effectiveness of Evolocumab in Reducing Major Adverse Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease” (Abstract MP1466).
Investigators noted that the findings reflect and extend results from the 2017 FOURIER trial, which demonstrated reduced MACE risk with evolocumab in patients with ASCVD over a median follow-up of 2.2 years.
“We are pleased to have partnered with Amgen on this important study that characterizes the long-term effectiveness of Repatha in reducing MACE in patients with ASCVD,” said M. Alan Brookhart, PhD, Senior Scientific Advisor at Target RWE. “It is compelling to see the benefits observed in the FOURIER trial reflected in a real-world patient population treated with Repatha.”
Leandro Boer, MD, PhD, US Medical Therapeutic Area Head for General Medicines at Amgen, added that the results “reinforce the urgency for healthcare providers to help patients achieve guideline-recommended LDL-C goals and lower their risk of life-altering events like heart attack or stroke.”
Implications for Clinical Practice
For primary care physicians managing patients with ASCVD, the findings provide additional evidence supporting the long-term effectiveness of evolocumab beyond clinical trial settings. The large sample size and extended follow-up period strengthen the real-world relevance of LDL-C–lowering strategies in reducing MACE risk.
Reference: Real-World Evidence [RWE] Demonstrates Repatha’s Long-Term Cardiovascular Benefits. News item. November 25, 2025. Accessed December 1, 2025. https://firstwordpharma.com/story/6688421
