Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events

The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab red...

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Autores: Szarek, Michael|||0000-0002-0046-0264, White, Harvey D., Schwartz, Gregory G., Alings, Marco, Bhatt, Deepak L|||0000-0002-1278-6245, Bittner, Vera A., Chiang, Chern-En, Diaz, Rafael, Edelberg, Jay M., Goodman, Shaun G., Hanotin, Corinne|||0000-0002-9396-3126, Harrington, R.A., Jukema, J.Wouter, Kimura, Takeshi, Kiss, Robert Gabor, Lecorps, Guillaume, Mahaffey, Kenneth W., Moryusef, Angèle, Pordy, Robert, Roe, Matthew T., Tricoci, Pierluigi, Xavier, Denis, Zeiher, Andreas Michael|||0000-0003-1711-5819, Steg, Ph Gabriel, Cequier Fillat, Angel R., García-Dorado, David|||0000-0002-1126-1279, Matas Pericas, Laia, Bruguera Cortada, Jordi, Gusi Tragant, Gabriel, Coca Payeras, Antonio
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:286552
Acceso en línea:https://ddd.uab.cat/record/286552
https://dx.doi.org/urn:doi:10.1016/j.jacc.2018.10.039
Access Level:acceso abierto
Palabra clave:Acute coronary syndrome
Alirocumab
Total events
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oai_identifier_str oai:ddd.uab.cat:286552
network_acronym_str ES
network_name_str España
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spelling Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal EventsThe ODYSSEY OUTCOMES TrialSzarek, Michael|||0000-0002-0046-0264White, Harvey D.Schwartz, Gregory G.Alings, MarcoBhatt, Deepak L|||0000-0002-1278-6245Bittner, Vera A.Chiang, Chern-EnDiaz, RafaelEdelberg, Jay M.Goodman, Shaun G.Hanotin, Corinne|||0000-0002-9396-3126Harrington, R.A.Jukema, J.WouterKimura, TakeshiKiss, Robert GaborLecorps, GuillaumeMahaffey, Kenneth W.Moryusef, AngèlePordy, RobertRoe, Matthew T.Tricoci, PierluigiXavier, DenisZeiher, Andreas Michael|||0000-0003-1711-5819Steg, Ph GabrielCequier Fillat, Angel R.García-Dorado, David|||0000-0002-1126-1279Matas Pericas, LaiaBruguera Cortada, JordiGusi Tragant, GabrielCoca Payeras, AntonioAcute coronary syndromeAlirocumabTotal eventsThe ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS.Universitat Autònoma de Barcelona 22019-01-0120192019-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/286552https://dx.doi.org/urn:doi:10.1016/j.jacc.2018.10.039reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2865522026-06-06T12:50:31Z
dc.title.none.fl_str_mv Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
The ODYSSEY OUTCOMES Trial
title Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
spellingShingle Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
Szarek, Michael|||0000-0002-0046-0264
Acute coronary syndrome
Alirocumab
Total events
title_short Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
title_full Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
title_fullStr Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
title_full_unstemmed Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
title_sort Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
dc.creator.none.fl_str_mv Szarek, Michael|||0000-0002-0046-0264
White, Harvey D.
Schwartz, Gregory G.
Alings, Marco
Bhatt, Deepak L|||0000-0002-1278-6245
Bittner, Vera A.
Chiang, Chern-En
Diaz, Rafael
Edelberg, Jay M.
Goodman, Shaun G.
Hanotin, Corinne|||0000-0002-9396-3126
Harrington, R.A.
Jukema, J.Wouter
Kimura, Takeshi
Kiss, Robert Gabor
Lecorps, Guillaume
Mahaffey, Kenneth W.
Moryusef, Angèle
Pordy, Robert
Roe, Matthew T.
Tricoci, Pierluigi
Xavier, Denis
Zeiher, Andreas Michael|||0000-0003-1711-5819
Steg, Ph Gabriel
Cequier Fillat, Angel R.
García-Dorado, David|||0000-0002-1126-1279
Matas Pericas, Laia
Bruguera Cortada, Jordi
Gusi Tragant, Gabriel
Coca Payeras, Antonio
author Szarek, Michael|||0000-0002-0046-0264
author_facet Szarek, Michael|||0000-0002-0046-0264
White, Harvey D.
Schwartz, Gregory G.
Alings, Marco
Bhatt, Deepak L|||0000-0002-1278-6245
Bittner, Vera A.
Chiang, Chern-En
Diaz, Rafael
Edelberg, Jay M.
Goodman, Shaun G.
Hanotin, Corinne|||0000-0002-9396-3126
Harrington, R.A.
Jukema, J.Wouter
Kimura, Takeshi
Kiss, Robert Gabor
Lecorps, Guillaume
Mahaffey, Kenneth W.
Moryusef, Angèle
Pordy, Robert
Roe, Matthew T.
Tricoci, Pierluigi
Xavier, Denis
Zeiher, Andreas Michael|||0000-0003-1711-5819
Steg, Ph Gabriel
Cequier Fillat, Angel R.
García-Dorado, David|||0000-0002-1126-1279
Matas Pericas, Laia
Bruguera Cortada, Jordi
Gusi Tragant, Gabriel
Coca Payeras, Antonio
author_role author
author2 White, Harvey D.
Schwartz, Gregory G.
Alings, Marco
Bhatt, Deepak L|||0000-0002-1278-6245
Bittner, Vera A.
Chiang, Chern-En
Diaz, Rafael
Edelberg, Jay M.
Goodman, Shaun G.
Hanotin, Corinne|||0000-0002-9396-3126
Harrington, R.A.
Jukema, J.Wouter
Kimura, Takeshi
Kiss, Robert Gabor
Lecorps, Guillaume
Mahaffey, Kenneth W.
Moryusef, Angèle
Pordy, Robert
Roe, Matthew T.
Tricoci, Pierluigi
Xavier, Denis
Zeiher, Andreas Michael|||0000-0003-1711-5819
Steg, Ph Gabriel
Cequier Fillat, Angel R.
García-Dorado, David|||0000-0002-1126-1279
Matas Pericas, Laia
Bruguera Cortada, Jordi
Gusi Tragant, Gabriel
Coca Payeras, Antonio
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Acute coronary syndrome
Alirocumab
Total events
topic Acute coronary syndrome
Alirocumab
Total events
description The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS.
publishDate 2019
dc.date.none.fl_str_mv 2
2019-01-01
2019
2019-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/286552
https://dx.doi.org/urn:doi:10.1016/j.jacc.2018.10.039
url https://ddd.uab.cat/record/286552
https://dx.doi.org/urn:doi:10.1016/j.jacc.2018.10.039
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
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