Real-World Study Shows Durable Cardiovascular Protection with Repatha
Target RWE, a leading organization in modern real-world evidence (RWE) generation and a trusted partner for regulatory-grade research, has announced significant new findings from the REPATHA-CE study—now recognized as the largest real-world comparative effectiveness study of Repatha® (evolocumab) in patients diagnosed with established atherosclerotic cardiovascular disease (ASCVD). The study evaluated more than 110,000 patients and revealed compelling results demonstrating that treatment with Repatha was associated with meaningful long-term reductions in major cardiovascular events when compared to patients not receiving the therapy.
According to the newly presented data, patients treated with Repatha experienced a 20% reduction in the composite risk of major cardiovascular events (MACE), including myocardial infarction (MI), stroke, and coronary revascularization. Additionally, the study found a 29% reduction in the composite rate of myocardial infarction, stroke, and cardiovascular-related death at the four-year follow-up mark compared with non-treated patients. These findings reinforce the sustained long-term benefit of Repatha outside controlled clinical trial environments, offering further confidence in its real-world clinical impact for patients living with a high risk of recurrent cardiovascular events.
The results were first showcased earlier this month during The American Heart Association (AHA) Scientific Sessions, one of the most prestigious global forums for cardiovascular science and research. The presentation, titled “Real-World Effectiveness of Evolocumab in Reducing Major Adverse Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease” (Abstract #MP1466), was delivered by scientists representing Target RWE and Amgen Inc. The study was made possible through Target RWE’s proprietary causalStudio™ platform, an advanced software ecosystem designed to generate high-quality causal inference data using complex real-world datasets.
The new findings also build upon clinical evidence generated years earlier. In 2017, Amgen conducted the landmark FOURIER clinical trial, which demonstrated Repatha’s ability to significantly reduce major adverse cardiovascular events in adults with established ASCVD and a prior cardiovascular event history. That trial had a median follow-up duration of 2.2 years. The latest analysis expands on that foundation by evaluating Repatha’s efficacy in a broader and more diverse real-world patient cohort, while also assessing outcomes over a longer follow-up period.
Using Komodo Health’s Healthcare Map®, one of the most comprehensive real-world patient databases in the United States, researchers were able to evaluate longitudinal healthcare interactions and clinical outcomes. The database includes de-identified healthcare information representing more than 330 million U.S. patients. From this vast dataset, the analysis identified 87,102 patients treated with Repatha and 24,609 patients who did not receive the therapy between 2017 and 2023. These large-scale, real-world datasets allow investigators to more accurately assess Repatha’s performance in diverse clinical settings and across varied patient demographics, care pathways, and risk profiles.
The strength of the findings and the scale of the dataset give new weight to the evidence supporting Repatha as a long-term therapeutic option for lowering cardiovascular risk in patients already diagnosed with ASCVD. Given that ASCVD remains one of the leading global causes of death and healthcare burden, therapies proven to reduce life-threatening events—especially outside controlled research environments—have important clinical, public health, and economic implications.
Speaking about the study, M. Alan Brookhart, PhD, Senior Scientific Advisor at Target RWE, emphasized the importance of validating controlled clinical trial outcomes in large datasets reflective of routine medical practice. “We are pleased to have partnered with Amgen on this important study that characterizes the long-term effectiveness of Repatha in reducing major cardiovascular events in patients with ASCVD. It is compelling to see the benefits observed in the FOURIER trial reflected in a real-world patient population treated with Repatha,” he stated.
Amgen leaders also responded positively to the findings. Leandro Boer, M.D., Ph.D., U.S. Medical Therapeutic Area Head for General Medicines at Amgen, noted that the results further confirm Repatha’s already well-documented potential and highlight the pressing need to improve cardiovascular risk management. “Clinical trials have demonstrated Repatha’s ability to significantly reduce the risk of major cardiovascular events in adults at high risk. This real-world analysis of more than 110,000 patients confirms those benefits in everyday care,” he said.
Dr. Boer added that the study also delivers a broader public health message—not just about treatment, but about the need for improved preventative strategies. “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,” he continued.
Collectively, the findings from the REPATHA-CE evaluation are expected to support broader adoption and confidence in evolocumab among clinicians, payers, and policy advisors, especially as the medical community continues to emphasize evidence-based treatment approaches for reducing recurrent cardiovascular events. With cardiovascular disease remaining one of the leading health threats globally, real-world evidence such as this plays a crucial role in bridging the gap between controlled clinical research and the realities of patient care—ultimately contributing to improved outcomes and long-term disease management.
About Target RWE
Target RWE generates real-world evidence (RWE) that informs strategic decisions across the drug development lifecycle. Our unique combination of clinical, analytical and technical expertise enables comprehensive insight generation from complete retrospective and prospective longitudinal patient journeys, with unparalleled scale and accuracy. Visit our website to learn more: https://targetrwe.com/.
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