Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study

Seijas Amigo, José; Mauriz Montero, María José; Suarez Artime, Pedro; Gayoso Rey, Mónica; Estany Gestal, Ana; Casás Martínez, Antonia; González Freire, Lara; Rodríguez Vázquez, Ana; Pérez-Rodriguez, N.; Villaverde Piñeiro, Laura; Castro Rubiños, Concepción; Espino-Faisán, E.; Rodríguez Mañero, Moises; Cordero, Alberto; González Juanatey, José Ramón; Paz-Couce, A.; Rodriguez-Penas, D.; Cardeso Paredes, Begoña; Seoane-Blanco, A.; Moure González, María; Soler-Martín, R.; Margusino Framiñán, Luis; Suarez-Rodriguez, A.; Rodriguez-Cobos, M.; Rojo-Valdés, J.; Zarra Ferro, Irene; Lorenzo Lorenzo, Karina; Casanova Martinez, Cristina; Crespo Diz, Carlos; Domínguez Guerra, María; González Pereira, María Elena; Anido García, María; Tajes-Gonzalez, I.M.; Mozo Peñalver, Hector José; Silva-Lopez, A.; Rodriguez-Sanchez, J.L.; García-Verde, M.J.

Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study

Introduction: The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in c...

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Autores:	Seijas Amigo, José, Mauriz Montero, María José, Suarez Artime, Pedro, Gayoso Rey, Mónica, Estany Gestal, Ana, Casás Martínez, Antonia, González Freire, Lara, Rodríguez Vázquez, Ana, Pérez-Rodriguez, N., Villaverde Piñeiro, Laura, Castro Rubiños, Concepción, Espino-Faisán, E., Rodríguez Mañero, Moises, Cordero, Alberto, González Juanatey, José Ramón, Paz-Couce, A., Rodriguez-Penas, D., Cardeso Paredes, Begoña, Seoane-Blanco, A., Moure González, María, Soler-Martín, R., Margusino Framiñán, Luis, Suarez-Rodriguez, A., Rodriguez-Cobos, M., Rojo-Valdés, J., Zarra Ferro, Irene, Lorenzo Lorenzo, Karina, Casanova Martinez, Cristina, Crespo Diz, Carlos, Domínguez Guerra, María, González Pereira, María Elena, Anido García, María, Tajes-Gonzalez, I.M., Mozo Peñalver, Hector José, Silva-Lopez, A., Rodriguez-Sanchez, J.L., García-Verde, M.J.
Tipo de recurso:	artículo
Fecha de publicación:	2023
País:	España
Institución:	Servizo Galego de Saúde (SERGAS)
Repositorio:	RUNA. Repositorio da Consellería de Sanidade e Sergas
OAI Identifier:	oai:runa.sergas.gal:20.500.11940/21242
Acceso en línea:	https://portalcientifico.sergas.gal//documentos/64f6356966ccc641d10d6d08 http://hdl.handle.net/20.500.11940/21242
Access Level:	acceso abierto
Palabra clave:	Humans PCSK9 Inhibitors Cholesterol, LDL Follow-Up Studies Proprotein Convertase 9 Prospective Studies Cognition Antibodies, Monoclonal AS Santiago IDIS AS A Coruña CHUAC ADOS AS Vigo CHUVI AS Ferrol CHUF AS Pontevedra CHUP AS Ourense CHUO AS Lugo HP Monforte HP A Mariña CHUS DXAS

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oai_identifier_str	oai:runa.sergas.gal:20.500.11940/21242
network_acronym_str	ES
network_name_str	España
repository_id_str
dc.title.none.fl_str_mv	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
title	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
spellingShingle	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study Seijas Amigo, José Humans PCSK9 Inhibitors Cholesterol, LDL Follow-Up Studies Proprotein Convertase 9 Prospective Studies Cognition Antibodies, Monoclonal AS Santiago IDIS AS A Coruña CHUAC ADOS AS Vigo CHUVI AS Santiago IDIS AS Ferrol CHUF AS Pontevedra CHUP AS Ourense CHUO AS Lugo HP Monforte AS Lugo HP A Mariña AS Santiago CHUS AS Santiago IDIS AS Santiago CHUS AS Santiago IDIS AS A Coruña CHUAC AS Santiago CHUS AS Ourense CHUVI DXAS AS Pontevedra CHUP AS A Coruña CHUAC AS Ourense CHUO AS Ourense CHUO AS Santiago CHUS
title_short	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
title_full	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
title_fullStr	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
title_full_unstemmed	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
title_sort	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study
dc.creator.none.fl_str_mv	Seijas Amigo, José Mauriz Montero, María José Suarez Artime, Pedro Gayoso Rey, Mónica Estany Gestal, Ana Casás Martínez, Antonia González Freire, Lara Rodríguez Vázquez, Ana Pérez-Rodriguez, N. Villaverde Piñeiro, Laura Castro Rubiños, Concepción Espino-Faisán, E. Rodríguez Mañero, Moises Cordero, Alberto González Juanatey, José Ramón Paz-Couce, A. Rodriguez-Penas, D. Cardeso Paredes, Begoña Seoane-Blanco, A. Moure González, María Soler-Martín, R. Margusino Framiñán, Luis Suarez-Rodriguez, A. Rodriguez-Cobos, M. Rojo-Valdés, J. Zarra Ferro, Irene Lorenzo Lorenzo, Karina Casanova Martinez, Cristina Crespo Diz, Carlos Domínguez Guerra, María González Pereira, María Elena Anido García, María Tajes-Gonzalez, I.M. Mozo Peñalver, Hector José Silva-Lopez, A. Rodriguez-Sanchez, J.L. García-Verde, M.J.
author	Seijas Amigo, José
author_facet	Seijas Amigo, José Mauriz Montero, María José Suarez Artime, Pedro Gayoso Rey, Mónica Estany Gestal, Ana Casás Martínez, Antonia González Freire, Lara Rodríguez Vázquez, Ana Pérez-Rodriguez, N. Villaverde Piñeiro, Laura Castro Rubiños, Concepción Espino-Faisán, E. Rodríguez Mañero, Moises Cordero, Alberto González Juanatey, José Ramón Paz-Couce, A. Rodriguez-Penas, D. Cardeso Paredes, Begoña Seoane-Blanco, A. Moure González, María Soler-Martín, R. Margusino Framiñán, Luis Suarez-Rodriguez, A. Rodriguez-Cobos, M. Rojo-Valdés, J. Zarra Ferro, Irene Lorenzo Lorenzo, Karina Casanova Martinez, Cristina Crespo Diz, Carlos Domínguez Guerra, María González Pereira, María Elena Anido García, María Tajes-Gonzalez, I.M. Mozo Peñalver, Hector José Silva-Lopez, A. Rodriguez-Sanchez, J.L. García-Verde, M.J.
author_role	author
author2	Mauriz Montero, María José Suarez Artime, Pedro Gayoso Rey, Mónica Estany Gestal, Ana Casás Martínez, Antonia González Freire, Lara Rodríguez Vázquez, Ana Pérez-Rodriguez, N. Villaverde Piñeiro, Laura Castro Rubiños, Concepción Espino-Faisán, E. Rodríguez Mañero, Moises Cordero, Alberto González Juanatey, José Ramón Paz-Couce, A. Rodriguez-Penas, D. Cardeso Paredes, Begoña Seoane-Blanco, A. Moure González, María Soler-Martín, R. Margusino Framiñán, Luis Suarez-Rodriguez, A. Rodriguez-Cobos, M. Rojo-Valdés, J. Zarra Ferro, Irene Lorenzo Lorenzo, Karina Casanova Martinez, Cristina Crespo Diz, Carlos Domínguez Guerra, María González Pereira, María Elena Anido García, María Tajes-Gonzalez, I.M. Mozo Peñalver, Hector José Silva-Lopez, A. Rodriguez-Sanchez, J.L. García-Verde, M.J.
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 author author author author author author author
dc.subject.none.fl_str_mv	Humans PCSK9 Inhibitors Cholesterol, LDL Follow-Up Studies Proprotein Convertase 9 Prospective Studies Cognition Antibodies, Monoclonal AS Santiago IDIS AS A Coruña CHUAC ADOS AS Vigo CHUVI AS Santiago IDIS AS Ferrol CHUF AS Pontevedra CHUP AS Ourense CHUO AS Lugo HP Monforte AS Lugo HP A Mariña AS Santiago CHUS AS Santiago IDIS AS Santiago CHUS AS Santiago IDIS AS A Coruña CHUAC AS Santiago CHUS AS Ourense CHUVI DXAS AS Pontevedra CHUP AS A Coruña CHUAC AS Ourense CHUO AS Ourense CHUO AS Santiago CHUS
topic	Humans PCSK9 Inhibitors Cholesterol, LDL Follow-Up Studies Proprotein Convertase 9 Prospective Studies Cognition Antibodies, Monoclonal AS Santiago IDIS AS A Coruña CHUAC ADOS AS Vigo CHUVI AS Santiago IDIS AS Ferrol CHUF AS Pontevedra CHUP AS Ourense CHUO AS Lugo HP Monforte AS Lugo HP A Mariña AS Santiago CHUS AS Santiago IDIS AS Santiago CHUS AS Santiago IDIS AS A Coruña CHUAC AS Santiago CHUS AS Ourense CHUVI DXAS AS Pontevedra CHUP AS A Coruña CHUAC AS Ourense CHUO AS Ourense CHUO AS Santiago CHUS
description	Introduction: The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in cognitive function domains, to analyze subgroups by the low-density lipoprotein cholesterol (LDL-C) achieved, and differences between alirocumab and evolocumab. Methods: This has a multicenter, quasi-experimental design carried out in 12 Spanish hospitals from May 2020 to February 2023. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). Results: Among 158 patients followed for a median of 99 weeks, 52% were taking evolocumab and 48% alirocumab; the mean change from baseline in MoCA score at follow-up was + 0.28 [95% CI (? 0.17 to 0.73; p = 0.216)]. There were no significant differences in the secondary endpoints-the visuospatial/executive domain + 0.04 (p = 0.651), naming domain ? 0.01 (p = 0.671), attention/memory domain + 0.01 (p = 0.945); language domain ? 0.10 (p = 0.145), abstraction domain + 0.03 (p = 0.624), and orientation domain ? 0.05 (p = 0.224)-but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (p = 0.001). Neither were there any differences in the three stratified subgroups according to lowest attained LDL-C level-0-54 mg/dL, 55-69 mg/dL and ? 70 mg/dL; p = 0.454-or between alirocumab and evolocumab arms. Conclusion: We did not find effect of monoclonal antibody PCSK9i on neurocognitive function over 24 months of treatment, either in global MoCA score or different cognitive domains. An improvement in delayed recall memory was shown. The study showed no differences in the cognitive function between the prespecified subgroups, even among patients who achieved very low levels of LDL-C. There were no differences between alirocumab and evolocumab. Registration: ClinicalTtrials.gov Identifier number NCT04319081.
publishDate	2023
dc.date.none.fl_str_mv	2023
dc.type.none.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://portalcientifico.sergas.gal//documentos/64f6356966ccc641d10d6d08 http://hdl.handle.net/20.500.11940/21242
url	https://portalcientifico.sergas.gal//documentos/64f6356966ccc641d10d6d08 http://hdl.handle.net/20.500.11940/21242
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
rights_invalid_str_mv	http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv	openAccess
dc.source.none.fl_str_mv	reponame:RUNA. Repositorio da Consellería de Sanidade e Sergas instname:Servizo Galego de Saúde (SERGAS)
instname_str	Servizo Galego de Saúde (SERGAS)
reponame_str	RUNA. Repositorio da Consellería de Sanidade e Sergas
collection	RUNA. Repositorio da Consellería de Sanidade e Sergas
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling	Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL StudySeijas Amigo, JoséMauriz Montero, María JoséSuarez Artime, PedroGayoso Rey, MónicaEstany Gestal, AnaCasás Martínez, AntoniaGonzález Freire, LaraRodríguez Vázquez, AnaPérez-Rodriguez, N.Villaverde Piñeiro, LauraCastro Rubiños, ConcepciónEspino-Faisán, E.Rodríguez Mañero, MoisesCordero, AlbertoGonzález Juanatey, José RamónPaz-Couce, A.Rodriguez-Penas, D.Cardeso Paredes, BegoñaSeoane-Blanco, A.Moure González, MaríaSoler-Martín, R.Margusino Framiñán, LuisSuarez-Rodriguez, A.Rodriguez-Cobos, M.Rojo-Valdés, J.Zarra Ferro, IreneLorenzo Lorenzo, KarinaCasanova Martinez, CristinaCrespo Diz, CarlosDomínguez Guerra, MaríaGonzález Pereira, María ElenaAnido García, MaríaTajes-Gonzalez, I.M.Mozo Peñalver, Hector JoséSilva-Lopez, A.Rodriguez-Sanchez, J.L.García-Verde, M.J.HumansPCSK9 InhibitorsCholesterol, LDLFollow-Up StudiesProprotein Convertase 9Prospective StudiesCognitionAntibodies, MonoclonalAS SantiagoIDISAS A CoruñaCHUACADOSAS VigoCHUVIAS SantiagoIDISAS FerrolCHUFAS PontevedraCHUPAS OurenseCHUOAS LugoHP MonforteAS LugoHP A MariñaAS SantiagoCHUSAS SantiagoIDISAS SantiagoCHUSAS SantiagoIDISAS A CoruñaCHUACAS SantiagoCHUSAS OurenseCHUVIDXASAS PontevedraCHUPAS A CoruñaCHUACAS OurenseCHUOAS OurenseCHUOAS SantiagoCHUSIntroduction: The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in cognitive function domains, to analyze subgroups by the low-density lipoprotein cholesterol (LDL-C) achieved, and differences between alirocumab and evolocumab. Methods: This has a multicenter, quasi-experimental design carried out in 12 Spanish hospitals from May 2020 to February 2023. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). Results: Among 158 patients followed for a median of 99 weeks, 52% were taking evolocumab and 48% alirocumab; the mean change from baseline in MoCA score at follow-up was + 0.28 [95% CI (? 0.17 to 0.73; p = 0.216)]. There were no significant differences in the secondary endpoints-the visuospatial/executive domain + 0.04 (p = 0.651), naming domain ? 0.01 (p = 0.671), attention/memory domain + 0.01 (p = 0.945); language domain ? 0.10 (p = 0.145), abstraction domain + 0.03 (p = 0.624), and orientation domain ? 0.05 (p = 0.224)-but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (p = 0.001). Neither were there any differences in the three stratified subgroups according to lowest attained LDL-C level-0-54 mg/dL, 55-69 mg/dL and ? 70 mg/dL; p = 0.454-or between alirocumab and evolocumab arms. Conclusion: We did not find effect of monoclonal antibody PCSK9i on neurocognitive function over 24 months of treatment, either in global MoCA score or different cognitive domains. An improvement in delayed recall memory was shown. The study showed no differences in the cognitive function between the prespecified subgroups, even among patients who achieved very low levels of LDL-C. There were no differences between alirocumab and evolocumab. Registration: ClinicalTtrials.gov Identifier number NCT04319081.Investigators received the support of the Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela (FIDIS) and National Network for Biomedical Cardiovascular Research of Cardiovascular Disease [Centro de Investigacion Biomedica en Red de Enfermedades Cardiovasculares (CIBERCV)]. Bonnie Dyer contributed to the English writing assistance.2023info:eu-repo/semantics/articlehttps://portalcientifico.sergas.gal//documentos/64f6356966ccc641d10d6d08http://hdl.handle.net/20.500.11940/21242reponame:RUNA. Repositorio da Consellería de Sanidade e Sergasinstname:Servizo Galego de Saúde (SERGAS)Ingléshttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:runa.sergas.gal:20.500.11940/212422026-06-12T08:40:47Z
score	15.812429

Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study

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