Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis

Digital

Autores:
Joseph, Philip
Roshandel, Gholamreza
Gao, Peggy
Pais, Prem
Lonn, Eva
Xavier, Denis
Avezum, Alvaro
Zhu, Jun
Liu, Lisheng
Sliwa, Karen
Gamra, Habib
Bangdiwala, Shrikant I.
Teo, Koon
Diaz, Rafael
Dans, Antonio
Lopez-Jaramillo, Patricio
Prabhakaran, Dorairaj
Castellano, Jose Maria
Fuster, Valentin
Rodgers, Anthony
Huffman, Mark D.
Bosch, Jackie
Dagenais, Gilles R.
Malekzadeh, Reza
Yusuf, Salim
Polypill Trialists' Collaboration
Tipo de recurso:
Article of journal
Fecha de publicación:
2021
Institución:
Universidad de Santander
Repositorio:
Repositorio Universidad de Santander
Idioma:
eng
OAI Identifier:
oai:repositorio.udes.edu.co:001/6114
Acceso en línea:
https://doi.org/10.1016/S0140-6736(21)01827-4
https://repositorio.udes.edu.co/handle/001/6114
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closedAccess
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© 2021 The Authors, Elsevier Ltd. All rights reserved.
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dc.title.spa.fl_str_mv Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
title Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
spellingShingle Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
title_short Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
title_full Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
title_fullStr Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
title_full_unstemmed Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
title_sort Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis
dc.creator.fl_str_mv Joseph, Philip
Roshandel, Gholamreza
Gao, Peggy
Pais, Prem
Lonn, Eva
Xavier, Denis
Avezum, Alvaro
Zhu, Jun
Liu, Lisheng
Sliwa, Karen
Gamra, Habib
Bangdiwala, Shrikant I.
Teo, Koon
Diaz, Rafael
Dans, Antonio
Lopez-Jaramillo, Patricio
Prabhakaran, Dorairaj
Castellano, Jose Maria
Fuster, Valentin
Rodgers, Anthony
Huffman, Mark D.
Bosch, Jackie
Dagenais, Gilles R.
Malekzadeh, Reza
Yusuf, Salim
Polypill Trialists' Collaboration
dc.contributor.author.none.fl_str_mv Joseph, Philip
Roshandel, Gholamreza
Gao, Peggy
Pais, Prem
Lonn, Eva
Xavier, Denis
Avezum, Alvaro
Zhu, Jun
Liu, Lisheng
Sliwa, Karen
Gamra, Habib
Bangdiwala, Shrikant I.
Teo, Koon
Diaz, Rafael
Dans, Antonio
Lopez-Jaramillo, Patricio
Prabhakaran, Dorairaj
Castellano, Jose Maria
Fuster, Valentin
Rodgers, Anthony
Huffman, Mark D.
Bosch, Jackie
Dagenais, Gilles R.
Malekzadeh, Reza
Yusuf, Salim
Polypill Trialists' Collaboration
dc.contributor.researchgroup.spa.fl_str_mv Masira
description Digital
publishDate 2021
dc.date.issued.none.fl_str_mv 2021-09-25
dc.date.accessioned.none.fl_str_mv 2022-02-22T21:04:22Z
dc.date.available.none.fl_str_mv 2022-02-22T21:04:22Z
dc.type.spa.fl_str_mv Artículo de revista
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url https://doi.org/10.1016/S0140-6736(21)01827-4
https://repositorio.udes.edu.co/handle/001/6114
dc.language.iso.spa.fl_str_mv eng
language eng
dc.relation.citationendpage.spa.fl_str_mv 1146
dc.relation.citationissue.spa.fl_str_mv 10306
dc.relation.citationstartpage.spa.fl_str_mv 1133
dc.relation.citationvolume.spa.fl_str_mv 398
dc.relation.cites.none.fl_str_mv Philip Joseph, Gholamreza Roshandel, Peggy Gao, Prem Pais, Eva Lonn, Denis Xavier, Alvaro Avezum, Jun Zhu, Lisheng Liu, Karen Sliwa, Habib Gamra, Shrikant I Bangdiwala, Koon Teo, Rafael Diaz, Antonio Dans, Patricio Lopez-Jaramillo, Dorairaj Prabhakaran, Jose Maria Castellano, Valentin Fuster, Anthony Rodgers, Mark D Huffman, Jackie Bosch, Gilles R Dagenais, Reza Malekzadeh, Salim Yusuf, Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis, The Lancet, Volume 398, Issue 10306, 2021, Pages 1133-1146, ISSN 0140-6736, https://doi.org/10.1016/S0140-6736(21)01827-4.
dc.relation.indexed.spa.fl_str_mv Scopus
dc.rights.spa.fl_str_mv © 2021 The Authors, Elsevier Ltd. All rights reserved.
dc.rights.coar.fl_str_mv http://purl.org/coar/access_right/c_14cb
dc.rights.accessrights.spa.fl_str_mv info:eu-repo/semantics/closedAccess
dc.rights.creativecommons.spa.fl_str_mv Atribución-NoComercial 4.0 Internacional (CC BY-NC 4.0)
dc.rights.uri.spa.fl_str_mv https://creativecommons.org/licenses/by-nc/4.0/
rights_invalid_str_mv © 2021 The Authors, Elsevier Ltd. All rights reserved.
Atribución-NoComercial 4.0 Internacional (CC BY-NC 4.0)
https://creativecommons.org/licenses/by-nc/4.0/
http://purl.org/coar/access_right/c_14cb
eu_rights_str_mv closedAccess
dc.format.extent.spa.fl_str_mv 14 p
dc.format.mimetype.spa.fl_str_mv application/pdf
dc.publisher.spa.fl_str_mv The Lancet
dc.publisher.place.spa.fl_str_mv Reino Unido
dc.source.spa.fl_str_mv https://www.sciencedirect.com/science/article/abs/pii/S0140673621018274#!
institution Universidad de Santander
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spelling Joseph, Philip35ddb523-bb0e-4c55-9a59-b24968824fbf-1Roshandel, Gholamrezafeb2621a-76cf-48bc-a41f-ed9c485f4d50-1Gao, Peggy46954da1-6290-4040-9c8c-33dcfaf225dd-1Pais, Prem5abdbf77-3c3f-4396-8634-83723aa215b9-1Lonn, Eva7a977a4b-14e3-44cc-8057-933d424aaa9b-1Xavier, Denis88c9cf48-fa3b-45c6-be03-2cc79e59289d-1Avezum, Alvaro8b920360-abb2-4ec8-b5ee-4e3f4e0b11eb-1Zhu, Jund97cdbd2-6a82-430c-abfe-c978f085997e-1Liu, Lishenga14adafe-ef37-42b0-8f5b-0de4ea71b0fc-1Sliwa, Karen7ff2b80f-9412-4d65-99cd-7d01d5578687-1Gamra, Habib1b3172ed-091a-41ca-bfb4-fb5570f87f4e-1Bangdiwala, Shrikant I.ce83fa9d-c515-475d-bf37-77b94384afe4-1Teo, Koon60475883-56ab-4acc-833d-b027ad828534-1Diaz, Rafaelf2be4a74-501a-4e63-8bbd-965cbcf8c57b-1Dans, Antoniof365ef5a-7610-4022-8485-31d6d3879cd6-1Lopez-Jaramillo, Patricio9a71267b-dcb0-4d31-b37d-2d30be58d4d2-1Prabhakaran, Dorairaj360f4921-c217-4323-bd85-794b4e28a513-1Castellano, Jose Maria00a768ae-6fca-468b-a586-0da1795a4018-1Fuster, Valentin7124cbd2-cf45-48ac-b1ed-3e9efd661a07-1Rodgers, Anthony14b497ee-cd53-4873-a11f-3c11fbe40657-1Huffman, Mark D.cd624a24-693b-413e-b9e2-e3a729450132-1Bosch, Jackie503f2202-0dda-463c-acc9-f5888e895278-1Dagenais, Gilles R.649af40f-e7a9-4172-baac-8e6c95a8dc4e-1Malekzadeh, Rezab9b5de7c-010d-42e7-92c9-b9bd334923fc-1Yusuf, Salim06a836b5-f5e3-41d9-a516-9cc46e5d7948-1Polypill Trialists' Collaboration56a5bfe8-4246-4499-9057-55d09db2c81f-1Masira2022-02-22T21:04:22Z2022-02-22T21:04:22Z2021-09-25DigitalBackground In randomised controlled trials, fixed-dose combination treatments (or polypills) have been shown to reduce a composite of cardiovascular disease outcomes in primary prevention. However, whether or not aspirin should be included, effects on specific outcomes, and effects in key subgroups are unknown. Methods We did an individual participant data meta-analysis of large randomised controlled trials (each with ≥1000 participants and ≥2 years of follow-up) of a fixed-dose combination treatment strategy versus control in a primary cardiovascular disease prevention population. We included trials that evaluated a fixed-dose combination strategy of at least two blood pressure lowering agents plus a statin (with or without aspirin), compared with a control strategy (either placebo or usual care). The primary outcome was time to first occurrence of a composite of cardiovascular death, myocardial infarction, stroke, or arterial revascularisation. Additional outcomes included individual cardiovascular outcomes and death from any cause. Outcomes were also evaluated in groups stratified by the inclusion of aspirin in the fixed-dose treatment strategy, and effect sizes were estimated in prespecified subgroups based on risk factors. Kaplan-Meier survival curves and Cox proportional hazard regression models were used to compare strategies. Findings Three large randomised trials were included in the analysis (TIPS-3, HOPE-3, and PolyIran), with a total of 18 162 participants. Mean age was 63·0 years (SD 7·1), and 9038 (49·8%) participants were female. Estimated 10-year cardiovascular disease risk for the population was 17·7% (8·7). During a median follow-up of 5 years, the primary outcome occurred in 276 (3·0%) participants in the fixed-dose combination strategy group compared with 445 (4·9%) in the control group (hazard ratio 0·62, 95% CI 0·53–0·73, p<0·0001). Reductions were also observed for the separate components of the primary outcome: myocardial infarction (0·52, 0·38–0·70), revascularisation (0·54, 0·36–0·80), stroke (0·59, 0·45–0·78), and cardiovascular death (0·65, 0·52–0·81). Significant reductions in the primary outcome and its components were observed in the analyses of fixed-dose combination strategies with and without aspirin, with greater reductions for strategies including aspirin. Treatment effects were similar at different lipid and blood pressure levels, and in the presence or absence of diabetes, smoking, or obesity. Gastrointestinal bleeding was uncommon but slightly more frequent in the fixed-dose combination strategy with aspirin group versus control (19 [0·4%] vs 11 [0·2%], p=0·15). The frequencies of haemorrhagic stroke (10 [0·2%] vs 15 [0·3%]), fatal bleeding (two [<0·1%] vs four [0·1%]), and peptic ulcer disease (32 [0·7%] vs 34 [0·8%]) were low and did not differ significantly between groups. Dizziness was more common with fixed-dose combination treatment (1060 [11·7%] vs 834 [9·2%], p<0·0001). Interpretation Fixed-dose combination treatment strategies substantially reduce cardiovascular disease, myocardial infarction, stroke, revascularisation, and cardiovascular death in primary cardiovascular disease prevention. These benefits are consistent irrespective of cardiometabolic risk factors.Ciencias Médica y de la Educación14 papplication/pdfhttps://doi.org/10.1016/S0140-6736(21)01827-4https://repositorio.udes.edu.co/handle/001/6114engThe LancetReino Unido1146103061133398Philip Joseph, Gholamreza Roshandel, Peggy Gao, Prem Pais, Eva Lonn, Denis Xavier, Alvaro Avezum, Jun Zhu, Lisheng Liu, Karen Sliwa, Habib Gamra, Shrikant I Bangdiwala, Koon Teo, Rafael Diaz, Antonio Dans, Patricio Lopez-Jaramillo, Dorairaj Prabhakaran, Jose Maria Castellano, Valentin Fuster, Anthony Rodgers, Mark D Huffman, Jackie Bosch, Gilles R Dagenais, Reza Malekzadeh, Salim Yusuf, Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis, The Lancet, Volume 398, Issue 10306, 2021, Pages 1133-1146, ISSN 0140-6736, https://doi.org/10.1016/S0140-6736(21)01827-4.Scopus© 2021 The Authors, Elsevier Ltd. All rights reserved.info:eu-repo/semantics/closedAccessAtribución-NoComercial 4.0 Internacional (CC BY-NC 4.0)https://creativecommons.org/licenses/by-nc/4.0/http://purl.org/coar/access_right/c_14cbhttps://www.sciencedirect.com/science/article/abs/pii/S0140673621018274#!Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysisArtículo de revistahttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1Textinfo:eu-repo/semantics/articlehttp://purl.org/redcol/resource_type/ARTinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85Todas las AudienciasPublicationORIGINALFixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease. An individual participant data meta-analysis.pdfFixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease. An individual participant data meta-analysis.pdfapplication/pdf218014https://repositorio.udes.edu.co/bitstreams/9bd50fe1-c667-4104-a983-e5571fcf45b6/download8758fc7413ef864d3b148567655fdc68MD51LICENSElicense.txtlicense.txttext/plain; charset=utf-859https://repositorio.udes.edu.co/bitstreams/057d3e31-6fd2-4343-8845-0420136f5ed4/download38d94cf55aa1bf2dac1a736ac45c881cMD52TEXTFixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease. An individual participant data meta-analysis.pdf.txtFixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease. An individual participant data meta-analysis.pdf.txtExtracted texttext/plain5https://repositorio.udes.edu.co/bitstreams/f664b2fb-49a7-4712-8d7e-23178c37754b/download5dbe86c1111d64f45ba435df98fdc825MD53THUMBNAILFixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease. An individual participant data meta-analysis.pdf.jpgFixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease. An individual participant data meta-analysis.pdf.jpgGenerated Thumbnailimage/jpeg9035https://repositorio.udes.edu.co/bitstreams/878e1868-7903-47ee-b75c-b5c8a436bff0/download34384f77f9bc479d3f002b35d277b81fMD54001/6114oai:repositorio.udes.edu.co:001/61142023-10-10 08:26:50.165https://creativecommons.org/licenses/by-nc/4.0/© 2021 The Authors, Elsevier Ltd. All rights reserved.https://repositorio.udes.edu.coRepositorio Universidad de Santandersoporte@metabiblioteca.comTGljZW5jaWEgZGUgUHVibGljYWNpw7NuIFVERVMKRGlyZWN0cmljZXMgZGUgVVNPIHkgQUNDRVNPCgo=