Jose Seijas-Amigo, Mª José Mauriz-Montero, Pedro Suarez-Artime, Mónica Gayoso-Rey, Ana Estany-Gestal, Antonia Casas-Martínez, Lara González-Freire, Ana Rodriguez-Vazquez, Natalia Pérez-Rodriguez, Laura Villaverde-Piñeiro, Concepción Castro-Rubinos, Esther Espino-Faisán, Moisés Rodríguez-Mañero, Alberto Cordero, José R. González-Juanatey, Investigadores MEMOGAL
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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.</p><h3>Methods</h3><p>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).</p><h3>Results</h3><p>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; <i>p</i> = 0.216)]. There were no significant differences in the secondary endpoints—the visuospatial/executive domain + 0.04 (<i>p</i> = 0.651), naming domain − 0.01 (<i>p</i> = 0.671), attention/memory domain + 0.01 (<i>p</i> = 0.945); language domain − 0.10 (<i>p</i> = 0.145), abstraction domain + 0.03 (<i>p</i> = 0.624), and orientation domain − 0.05 (<i>p</i> = 0.224)—but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (<i>p</i> = 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; <i>p</i> = 0.454—or between alirocumab and evolocumab arms.</p><h3>Conclusion</h3><p>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.</p><h3>Registration</h3><p>ClinicalTtrials.gov Identifier number NCT04319081.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"23 5","pages":"583 - 593"},"PeriodicalIF":2.8000,"publicationDate":"2023-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7d/39/40256_2023_Article_604.PMC10462529.pdf","citationCount":"0","resultStr":"{\"title\":\"Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World—MEMOGAL Study\",\"authors\":\"Jose Seijas-Amigo, Mª José Mauriz-Montero, Pedro Suarez-Artime, Mónica Gayoso-Rey, Ana Estany-Gestal, Antonia Casas-Martínez, Lara González-Freire, Ana Rodriguez-Vazquez, Natalia Pérez-Rodriguez, Laura Villaverde-Piñeiro, Concepción Castro-Rubinos, Esther Espino-Faisán, Moisés Rodríguez-Mañero, Alberto Cordero, José R. 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Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA).</p><h3>Results</h3><p>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; <i>p</i> = 0.216)]. There were no significant differences in the secondary endpoints—the visuospatial/executive domain + 0.04 (<i>p</i> = 0.651), naming domain − 0.01 (<i>p</i> = 0.671), attention/memory domain + 0.01 (<i>p</i> = 0.945); language domain − 0.10 (<i>p</i> = 0.145), abstraction domain + 0.03 (<i>p</i> = 0.624), and orientation domain − 0.05 (<i>p</i> = 0.224)—but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (<i>p</i> = 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; <i>p</i> = 0.454—or between alirocumab and evolocumab arms.</p><h3>Conclusion</h3><p>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. 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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 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.
期刊介绍：
Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents.
Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations.
The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
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