RT Journal Article
T1 Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World—MEMOGAL Study
A1 Seijas-Amigo, José
A1 Mauriz-Montero, Mª José
A1 Suárez Artime, Pedro
A1 Gayoso-Rey, Mónica
A1 Estany Gestal, Ana
A1 Casas-Martínez, Antonia
A1 González Freire, Lara
A1 Rodríguez-Vázquez, Ana
A1 Pérez-Rodríguez, Natalia
A1 Villaverde-Piñeiro, Laura
A1 Castro-Rubinos, Concepción
A1 Espino-Faisán, Esther
A1 Rodríguez Mañero, Moisés
A1 Cordero, Alberto
A1 González Juanatey, José Ramón
A1 Paz-Couce, Adrián
A1 Rodriguez-Penas, Diego
A1 Cardeso-Paredes, Begoña
A1 Seoane-Blanco, Ana
A1 Moure-Gonzalez, María
A1 Soler-Martín, Rita
A1 Margusino-Framiñan, Luis
A1 Suárez Rodríguez, Ana
A1 Rodríguez Cobos, Marisol
A1 Rojo-Valdés, Juan
A1 Zarra Ferro, Irene
A1 Lorenzo-Lorenzo, Karina
A1 Casanova-Martinez, Cristina
A1 Crespo-Diz, Carlos
A1 Domínguez Guerra, María
A1 González-Pereira, María Elena
A1 Anido-García, María
A1 Tajes-Gonzalez, Iveth Michelle
A1 Mozo-Peñalver, Héctor
A1 Silva-Lopez, Alicia
A1 Rodríguez Sánchez, José Luis
A1 García-Verde, María Jesús
K1 PCSK9 Inhibitors
K1 Monoclonal antibody proprotein
K1 Cognitive function
K1 Study
AB IntroductionThe 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.MethodsThis 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).ResultsAmong 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.ConclusionWe 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.RegistrationClinicalTtrials.gov Identifier number NCT04319081
PB Springer
SN 1175-3277
YR 2023
FD 2023-08-23
LK http://hdl.handle.net/10347/31162
UL http://hdl.handle.net/10347/31162
LA eng
NO American Journal of Cardiovascular Drugs (2023) 23:583–593
NO Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature
DS Minerva
RD 28 abr 2026