en.Wedoany.com Reported - Amgen announced new overall and subgroup results from the Phase 3 VESALIUS-CV trial of Repatha (evolocumab) at the 86th Scientific Sessions of the American Diabetes Association (ADA). Overall trial data showed that adding Repatha to lipid-lowering therapies such as statins reduced the risk of the composite primary endpoint of coronary heart disease death, myocardial infarction, or ischemic stroke (3-P MACE) by 25% compared with placebo, reduced the risk of the second composite primary endpoint including ischemia-driven revascularization (4-P MACE) by 19%, and reduced the risk of myocardial infarction by 36%. These overall results were published in the New England Journal of Medicine in November 2025.
The subgroup analysis focused on 6,002 patients with high-risk diabetes (microvascular disease, insulin use, or diabetes duration ≥10 years) and elevated low-density lipoprotein cholesterol (LDL-C) but no prior heart attack or stroke. In this subgroup, adding Repatha reduced the risk of 3-P MACE by 29% and 4-P MACE by 21%. Data from 898 patients in the lipid substudy showed that median LDL-C decreased to 45 mg/dL in the Repatha group versus 106 mg/dL in the placebo group. Approximately one-third of patients used sodium-glucose cotransporter 2 (SGLT2) inhibitors and one-fifth used glucagon-like peptide-1 (GLP-1) receptor agonists during the study, and similar benefits were observed with Repatha regardless of whether these therapies were received.
Jay Bradner, M.D., Executive Vice President of Research and Development, Artificial Intelligence, and Data at Amgen, noted that patients with diabetes have twice the risk of heart attack or stroke compared to those without diabetes, and the VESALIUS-CV results show that early intensive reduction of LDL-C to 45 mg/dL is critical for preventing cardiovascular events in high-risk patients. Amgen also presented multiple real-world evidence studies showing that while GLP-1 therapies improve glycemic control and weight, patient persistence and adherence remain low in routine clinical practice, with many patients discontinuing within the first year, potentially limiting the ability to achieve guideline-recommended targets.
VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled global clinical trial that enrolled over 12,000 patients with known atherosclerotic cardiovascular disease (ASCVD) or high-risk diabetes, no history of heart attack or stroke, LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL. Participants had a median baseline LDL-C of 122 mg/dL and a median follow-up of approximately 4.6 years. Repatha is a human monoclonal antibody that lowers LDL-C by inhibiting PCSK9 to increase the number of LDL receptors on the surface of liver cells. Since its initial approval in 2015, it has been used by over 8 million patients worldwide. In August 2025, the U.S. Food and Drug Administration expanded the approved use of Repatha to include adults with uncontrolled LDL-C at increased risk for major adverse cardiovascular events, and the drug is approved in 74 countries.
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