RWE Supports Repatha’s Effectiveness in Reducing Major Adverse Cardiovascular Events (MACE) in Patients with ASCVD

Data Presented at American Heart Association Scientific Sessions 2025

Target RWE, a leader in advancing modern evidence generation for complex clinical and regulatory challenges, today announced the presentation of compelling new findings from the REPATHA-CE study of more than 110,000 patients, the largest real-world comparative effectiveness evaluation of patients with established atherosclerotic cardiovascular disease (ASCVD) treated with Repatha® (evolocumab). The results reveal that treatment with Repatha is associated with a 20% lower risk in composite major cardiovascular events (MACE) of myocardial infarction (MI), stroke and coronary revascularization and a 29% lower risk of composite MACE of MI, stroke and cardiovascular death at four years compared to patients not treated with Repatha.

The results were released earlier this month at The American Heart Association Scientific Sessions in a presentation titled “Real-World Effectiveness of Evolocumab in Reducing Major Adverse Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease” (Abstract # MP1466). The study was conducted by Target RWE and Amgen Inc. and used Target RWE’s propriety causalStudio™ software platform.

In 2017, the FOURIER trial conducted by Amgen demonstrated that Repatha reduced the risk of MACE in people with established ASCVD and a history of MACE with a median follow-up of 2.2 years. In this new study, researchers sought to evaluate the real-world effectiveness of Repatha in reducing MACE in patients with ASCVD.

Patients treated with Repatha experienced a 20% lower relative risk of composite MACE of MI, stroke and coronary revascularization (RR = 0.80; 95% CI: 0.73–0.86) and a 29% lower relative risk of composite MACE of MI, stroke and cardiovascular death (RR = 0.71; 95% CI: 0.64-0.78) at four years compared to those not treated, underscoring Repatha’s sustained, real-world impact on cardiovascular outcomes. The analysis drew on Komodo’s Healthcare Map®, a database of de-identified, real-world patient data, representing the individual healthcare experiences of more than 330 million de-identified U.S. patients, and included 87,102 Repatha treated and 24,609 non-treated patients identified between 2017 and 2023.

“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.”

"Clinical trials have demonstrated Repatha's ability to significantly reduce the risk of major cardiovascular events in adults at high-risk. This analysis of real-world data in more than 110,000 patients with cardiovascular disease confirms those benefits in everyday care," said Leandro Boer, M.D., Ph.D., US Medical Therapeutic Area Head for General Medicines at Amgen. "Beyond underscoring the utility of Repatha, these 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."

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