Details

Autor(en) / Beteiligte

• Everett, Brendan M
• Smith, Robert J
• Hiatt, William R

Titel

Reducing LDL with PCSK9 Inhibitors — The Clinical Benefit of Lipid Drugs

Ist Teil von

• The New England journal of medicine, 2015-10, Vol.373 (17), p.1588-1591

Ort / Verlag

United States: Massachusetts Medical Society

Erscheinungsjahr

2015

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• Despite limitations in the data on the two new PCSK9 inhibitors, an FDA advisory committee has voted to approve alirocumab and evolocumab. But committee members emphatically stated that LDL cholesterol levels are not a reliable surrogate for cardiovascular benefit. In early June, the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration (FDA), on which we serve, met to consider marketing applications for the new molecular entities alirocumab and evolocumab on the basis of their ability to lower low-density lipoprotein (LDL) cholesterol levels and their effects on other lipid fractions in patients at risk for cardiovascular disease. These first-in-class medications are fully humanized monoclonal antibodies that inactivate proprotein convertase subtilisin–kexin type 9 (PCSK9). That inactivation results in decreased LDL-receptor degradation, increased recirculation of the receptor to the surface of hepatocytes, and consequent lowering of LDL cholesterol . . .