THOUSAND OAKS (dpa-AFX) - Biotechnology giant Amgen (AMGN) Saturday announced new detailed data from three Phase 3 studies that showed treatment with its novel investigational cholesterol-lowering drug evolocumab resulted in a statistically significant reduction of 55-66 percent in low-density lipoprotein cholesterol (LDL-C) compared with placebo in patients with high cholesterol.
Results from the three Phase 3 studies, MENDEL-2, DESCARTES and RUTHERFORD-2, were presented as Featured Clinical Research in a Special Session at the American College of Cardiology's 63rd Annual Scientific Session.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.
The three Phase 3 studies evaluated evolocumab in different patient populations: as monotherapy in patients with high cholesterol (MENDEL-2); as a long-term 52-week therapy in patients with high cholesterol on risk-based lipid-lowering therapy (DESCARTES); and in combination with statins and other lipid-lowering therapies in patients with heterozygous familial hypercholesterolemia, a genetic disorder characterized by elevated LDL-C levels (RUTHERFORD-2).
In MENDEL-2, the most common adverse events were headache, diarrhea, nausea and urinary tract infection. The most common AEs in the DESCARTES study were nasopharyngitis, upper respiratory tract infection, influenza and back pain. In RUTHERFORD-2, the most common AEs were nasopharyngitis, headache, contusion, back pain, nausea, arthralgia, upper respiratory tract infection, influenza, myalgia and pain in extremity.
High cholesterol is the most common form of dyslipidemia, which is an abnormality of lipids in the blood. There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe. According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C5, or bad cholesterol, and elevated LDL-C is recognized as a major risk factor for cardiovascular disease.
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