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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Cardiovascular efficacy and safety of bococizumab in high-risk patients
New England Journal of Medicine, Volume 376, No. 16, Year 2017
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Description
BACKGROUND Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients. © 2017 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
Ridker, Paul M.
United States, Boston
Brigham and Women's Hospital
Revkin, James H.
United States, New York
Pfizer Inc.
Amarenco, Pierre
France, Paris
Sorbonne Paris Cité Université Paris Diderot
Brunell, Robert M.
United States, New York
Pfizer Inc.
Curto, Madelyn
United States, New York
Pfizer Inc.
Civeira, Fernando
Spain, Zaragoza
Instituto de Investigación Sanitaria Aragón Iisa
Flather, Marcus D.
United Kingdom, Norwich
University of East Anglia
Glynn, Robert James
United States, Boston
Brigham and Women's Hospital
Greǵoire, Jean C.
Canada, Montreal
University of Montreal
Jukema, Johan Wouter
Netherlands, Leiden
Leids Universitair Medisch Centrum
Karpov, Yu Aleksandrovich
Russian Federation, Moscow
National Medical Research Center of Cardiology of the Ministry of Healthcare of the Russian Federation
Kastelein, Johannes Jacob Pieter
Netherlands, Amsterdam
Amsterdam Umc - University of Amsterdam
Koenig, Wolfgang F.
Germany, Munich
Technische Universität München
Lorenzatti, Alberto J.
Argentina, Cordoba
Cordoba Hospital
Manga, Pravin
South Africa, Johannesburg
University of the Witwatersrand
Masiukiewicz, Urszula S.
United States, New York
Pfizer Inc.
Miller, Michael B.
United States, Baltimore
University of Maryland, Baltimore Umb
Mosterd, Arend
Netherlands, Amersfoort
Meander Medical Center
Murín, Ján
Slovakia, Bratislava
Univerzita Komenského V Bratislave
Nicolau, José Carlos
Brazil, Sao Paulo
Universidade de São Paulo
Nissen, Steven E.
United States, Cleveland
Cleveland Clinic Foundation
Ponikowski, Piotr P.
Poland, Wroclaw
Wroclaw Medical University
Santos, Raul D.
Brazil, Sao Paulo
Universidade de São Paulo
Schwartz, Pamela F.
United States, New York
Pfizer Inc.
Soran, Handrean
United Kingdom, Manchester
Manchester University Nhs Foundation Trust
White, Harvey D.
New Zealand, Auckland
Auckland City Hospital
Wright, Richard Scott
United States, Rochester
Mayo Clinic
Vrablík, M.
Czech Republic, Prague
Charles University
Yunis, Carla
United States, New York
Pfizer Inc.
Shear, Charles L.
United States, New York
Pfizer Inc.
Tardif, Jean Claude
Canada, Montreal
University of Montreal
Conde, D.
Unknown Affiliation
Colquhoun, David M.
Unknown Affiliation
Missault, L.
Unknown Affiliation
Grégoire, J.
Unknown Affiliation
Gao, Runlin
Unknown Affiliation
Urina-Triana, Manuel
Unknown Affiliation
Solar, Miroslav
Unknown Affiliation
Jensen, Henrik Kjœrulf
Unknown Affiliation
Grobbee, Diederick E Egbertus
Unknown Affiliation
Savolainen, Markku Juhani
Unknown Affiliation
Schiele, F. N.
Unknown Affiliation
Montalescot, Gilles
Unknown Affiliation
Édes, István Ferenc
Unknown Affiliation
Blake, Gavin J.
Unknown Affiliation
Lotan, Chaim S.
Unknown Affiliation
Maggioni, Aldo Pietro
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Savonitto, Stefano
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Leiva-Pons, José Luís
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Dan, G. A.
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Cortada, Jordi Bruguera
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Mellbin, Linda Garcia
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Kahan, Thomas
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Noble, Steṕhane L.
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Hwang, Juey-Jen
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Sritara, Piyamitr
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Tokgözoǧlu, Sadberk Lâle
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Tarasenko, Lisa
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Borer, Jeffrey S.
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Black, Henry Richard
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Carmena, Rafael
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Furie, Karen Lisa
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McMurray, John JV
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Neaton, James D.
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Zannad, Faïez Mohamed
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O’Neill, B.
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Welty, Francine K.
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Chun, H.
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Jacoby, Douglas S.
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McPherson, Charles E.
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Pinto, Diana
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Silverman, I. E.
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Foody, Jo Anne Micale
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Pride, Yuri B.
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Vogel, Daniel R.
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Hershson, Alejandro Rubén
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Maffei, Laura Elena
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Zaidman, Cesar Javier
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Lúquez, Hugo A.
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Cuadrado, Jesus A.
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Sala, Jorgelina M.
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Vico, Marisa Liliana
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Stranks, Stephen N.
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van Gaal, William Joseph
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de Sutter, Johan H.
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Descamps, Olivier S.
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Ritt, Luiz Eduardo Fonteles
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Shechter, Michael
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Antonicelli, Roberto
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Sesti, Giorgio
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Perrone-Filardi, P.
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Averna, Maurizio
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Pirro, Matteo
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Arca, Marcello
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Fedele, Francesco
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Molina, Carlos Alberto
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Ramos López, Gabriel Arturo
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Liem, Su San
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Groutars, Reginald G.E.J.
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Hovingh, Gerard Kees
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van Royen, Niels
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Groenemeijer, Björn E.
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Kamphuisen, P. Willem
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Cequier, Ángel R.
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González-Juanatey, Carlos
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García-Puig, Juan
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Tuñón, José
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Hernández-García, José Mária De La Torre
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Ripoll Vera, T. V.
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Masana, Lluis L.
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Gónzalez-Juanatey, José Ramón
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Muñiz-Grijalvo, Ovidio
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Boman, Kurt O.A.
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Tengmark, Bengt Olov
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Hagström, Emil G.
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Müller, Christian E.
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MacH, François
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Wuerzner, Grégoire Crossed D.Sign©goire
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Moccetti, Tiziano
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Miserez, A. R.
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Ueng, Kwo Chiang
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Krittayaphong, Rungroj
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Kiatchoosakun, Songsak
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Göktekín, Ömer
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Y̌igit, Zerrin
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Çömlekçı, Abdurrahman
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Kayikçioǧlu, Meral
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Sharma, Rajan K.
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Lip, Gregory Y.H.
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Marshall, Andrew G.
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Jhund, Pardeep S.
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Sathyapalan, T.
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Nair, Devaki R.
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Thom, Simon Alistair Mc Gillivray
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Moriarty, Andrew J.
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Halcox, Julian PJ J.
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Gorog, Diana Adrienne
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Rubenfire, Melvyn
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Erdmann, Jeanette Ali
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Riesenberg, Robert A.
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Statistics
Citations: 493
Authors: 329
Affiliations: 22
Identifiers
Doi:
10.1056/NEJMoa1701488
ISSN:
00284793
Research Areas
Environmental
Noncommunicable Diseases
Study Design
Cohort Study