Findings Represent Largest and Most Rigorous Head-to-Head Real-World Outcomes Analysis of Repatha and Ezetimibe
Study Examined More Than Half a Million Adults Living with Heart Disease
Results Provide Important New Clinical Evidence to Inform Non-Statin Treatment Decisions for Patients
"We have known for decades that lowering LDL cholesterol reduces cardiovascular risk, yet many patients with ASCVD cannot reach recommended levels with statins alone," said
Among patients with a baseline low-density lipoprotein cholesterol (LDL-C) measurement (N = 225,048), the four-year cumulative risk of heart attack was lower with Repatha than with ezetimibe, an oral medicine that lowers LDL-C by limiting cholesterol absorption (5.88% vs. 7.76%). The analysis compared cardiovascular outcomes across a large patient population using rigorous analytical methods. The study is distinctive in its scale and approach to analyzing outcomes in the real world, requiring precise investigative methods to provide a large, practical evidence base that evaluates cardiovascular outcomes between the two treatments. Its findings provide a practical real-world complement to clinical trial evidence and may help inform clinical practice.
"While the recent ACC/AHA Multisociety Guideline update recognizes both ezetimibe and PCSK9 inhibitors like evolocumab as non-statin options for patients with ASCVD, clinicians have lacked direct cardiovascular outcomes evidence to help inform treatment choices for their patients that may allow them to fully achieve the recommended LDL-C goals of <70 mg/dL and <55 mg/dL," said
This real-world study used a rigorous design that mirrors a randomized clinical trial to compare cardiovascular outcomes among adults with ASCVD who initiated Repatha or ezetimibe in routine
About the Real-World Comparative Study
The Real-World Comparative Effectiveness of Evolocumab Versus Ezetimibe in Adults with Atherosclerotic Cardiovascular Disease: An Active-Comparator New-User Study is a non-interventional, active-comparator, new-user cohort study that applied a target trial framework to compare cardiovascular outcomes among adults with ASCVD and prior statin use who initiated evolocumab or ezetimibe in routine
Treatment with evolocumab lowered the rate of fatal or nonfatal MI by 20% compared with ezetimibe (HR, 0.80; 95% CI, 0.70-0.91). Among patients without an available baseline LDL-C measurement, the corresponding four-year cumulative risks were 5.65% and 7.06%, respectively. The study used inverse probability weighting to balance measured baseline characteristics between treatment groups and a calibrated estimator to account for incomplete availability of baseline LDL-C; a prespecified sensitivity analysis that continued follow-up regardless of changes in background statin therapy produced consistent results.
Cardiovascular disease (CVD) remains a major global health threat, linked to multiple interrelated risk factors like high LDL-C, Lp(a), obesity, diabetes and hypertension.1,2 These risks often coexist and require a comprehensive approach to prevention and care.
About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles.2 The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.3 Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention, with patients achieving and maintaining dramatic LDL-C reductions using Repatha once every two weeks.4,5
Repatha was first approved in 2015 and has since been used by approximately 9 million patients globally.6 In
INDICATIONS
Repatha® is indicated:
The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia.
IMPORTANT SAFETY INFORMATION
Please see full Prescribing Information.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.
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REFERENCES
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