Results of 5 phase 3 studies evaluating evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood, were presented at the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), in Washington, D.C
Results of 5 phase 3 studies evaluating evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood, were presented at the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), in Washington, D.C
The data presented are part of Amgen's large and comprehensive evolocumab clinical trial program, PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations), which is evaluating evolocumab in 20 clinical trials, with a combined planned enrollment of nearly 30,000 patients.
Results from the 5 phase 3 studies consistently demonstrated statistically significant reductions in LDL-C across a number of at-risk patient groups with elevated cholesterol. The trials evaluated evolocumab administered every 2 weeks and monthly in combination with statins in patients with hyperlipidemia (LAPLACE-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2); as a monotherapy in patients with high cholesterol (MENDEL-2); and in combination with statins and other lipid-lowering therapies in patients whose elevated cholesterol is caused by a genetic disorder called heterozygous familial hypercholesterolemia (RUTHERFORD-2). Additionally, the DESCARTES study evaluated evolocumab administered monthly as a long-term 52-week therapy in patients with high cholesterol on risk-based lipid lowering therapy.
“The positive results . . . show that evolocumab could be a promising lipid-lowering treatment for patients with high cholesterol who struggle to keep their LDL-C levels under control despite currently available treatments,” said LAPLACE-2 lead investigator Jennifer G. Robinson, MD, MPH, director of the Prevention Intervention Center, professor of the Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. “While statins are effective in reducing LDL cholesterol levels and the risk of heart attack and stroke, some patients still need more LDL-lowering treatment options.”
Cardiovascular disease (CVD) is the number 1 cause of death worldwide and major cardiovascular events lead to increased direct healthcare costs, including hospitalizations and CVD-related procedures. Overall, the total direct and indirect cost of CVD in the U.S. for 2010 is estimated to be $444.2 billion.
Findings from the 5 studies evaluating evolocumab presented at ACC.14 are as follows:
The DESCARTES study was simultaneously published in the New England Journal of Medicine, and the MENDEL-2 and GAUSS-2 studies were simultaneously published in the Journal of the American College of Cardiology.