Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

• Published in: The New England journal of medicine Vol. 376; no. 16; pp. 1527 - 1539
• Main Authors: Ridker, Paul M, Revkin, James, Amarenco, Pierre, Brunell, Robert, Curto, Madelyn, Civeira, Fernando, Flather, Marcus, Glynn, Robert J, Gregoire, Jean, Jukema, J. Wouter, Karpov, Yuri, Kastelein, John J.P, Koenig, Wolfgang, Lorenzatti, Alberto, Manga, Pravin, Masiukiewicz, Urszula, Miller, Michael, Mosterd, Arend, Murin, Jan, Nicolau, Jose C, Nissen, Steven, Ponikowski, Piotr, Santos, Raul D, Schwartz, Pamela F, Soran, Handrean, White, Harvey, Wright, R. Scott, Vrablik, Michal, Yunis, Carla, Shear, Charles L, Tardif, Jean-Claude
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 20.04.2017
• Subjects: Angina; Antibodies - blood; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - immunology; Antibodies, Monoclonal, Humanized - therapeutic use; Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - immunology; Anticholesteremic Agents - therapeutic use; Cardiac and Cardiovascular Systems; Cardiovascular disease; Cardiovascular diseases; Cardiovascular Diseases - prevention & control; Cerebral infarction; Cholesterol; Cholesterol, LDL - blood; Clinical Medicine; Clinical trials; Disease prevention; Double-Blind Method; Female; Follow-Up Studies; Human health and pathology; Humans; Hypercholesterolemia - drug therapy; Immunoglobulins; Injections, Subcutaneous - adverse effects; Kardiologi; Kexin; Klinisk medicin; Life Sciences; Lipids; Lipids - blood; Low density lipoprotein; Male; Medical and Health Sciences; Medicin och hälsovetenskap; Middle Aged; Monoclonal antibodies; Myocardial infarction; Proprotein Convertase 9 - antagonists & inhibitors; Proprotein Convertase 9 - immunology; Proprotein convertases; Risk Factors; Risk groups; Stroke; Subtilisin; Treatment Failure
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1701488

In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the lower-risk group but did have a significant benefit in the higher-risk group. Monoclonal antibodies that inhibit proprotein convertase subtilisin–kexin type 9 (PCSK9) lower levels of plasma low-density lipoprotein (LDL) cholesterol and are promising agents for vascular risk reduction. 1 Patients who have received the fully human monoclonal antibodies evolocumab and alirocumab, for example, have had reductions in cardiovascular events in preliminary analyses; these drugs are under evaluation in large-scale trials involving patients with known cardiovascular disease. 2 , 3 Bococizumab is a third inhibitor of PCSK9 that, unlike evolocumab and alirocumab, is a humanized monoclonal antibody in which approximately 3% of the murine sequence remains in the antigen-binding complementarity-determining region. As part of the Studies . . .