Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol
<p><strong>Objective:</strong> PCSK9 inhibitors have been shown to reduce LDLc by up to about 60% and 85% when used with high doses of statins and ezetimibe (2019 ESC/EAS Guidelines). These therapies may lead to very low levels of LDLc and have been associated with possible cogn...
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doaj-0fa7210cbe5e4aa9986ca92c28f9233c2021-05-31T16:35:50ZengGrupo Aula MédicaFarmacia Hospitalaria1130-63432171-86952021-05-01450315015410.7399/fh.11569Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocolJosé Seijas-Amigo0Diego Rodríguez-Penas1Ana Estany-Gestal2Pedro Suárez-Artime3María Santamaría-Cadavid4José Ramón González-Juanatey5Servicio de Cardiología, Complexo Hospitalario Universitario de Santiago de Compostela (A Coruña). Spain.Servicio de Cardiología, Complexo Hospitalario Universitario de Santiago de Compostela (A Coruña). Spain.FIDIS-Unidad de Epidemiología e Investigación Clínica, Santiago de Compostela (A Coruña). Spain.Servicio de Farmacia, Complexo Hospitalario Universitario de Santiago de Compostela (A Coruña). Spain.Servicio de Neurología, Complexo Hospitalario Universitario de Santiago de Compostela (A Coruña). Spain.Servicio de Cardiología, Complexo Hospitalario Universitario de Santiago de Compostela (A Coruña). Spain.<p><strong>Objective:</strong> PCSK9 inhibitors have been shown to reduce LDLc by up to about 60% and 85% when used with high doses of statins and ezetimibe (2019 ESC/EAS Guidelines). These therapies may lead to very low levels of LDLc and have been associated with possible cognitive deterioration. No significant differences were found in the only specific study (EBBINGHAUS). The objective is to prospectively evaluate cognitive deterioration and its repercussion on quality of life and changes in LDLc in patients starting treatment with PCKS9 inhibitors.</p><p><strong>Method:</strong> It is a postauthorization, multicentre, non-randomized, prospective study. Patients starting treatment for the first time with PCSK9 inhibitors will be recruited in 11 Galician Hospitals over a period of 12 months and with 24 months of follow-up. The primary outcome will be to evaluate changes in cognitive function using the Montreal Cognitive Assessment (MOCA) questionnaire. The secondary outcome will be to evaluate changes in quality of life using the EuroQol-5D. Changes in LDLc will be assessed. The sample size will be 275 patients, taking into <br />account a loss to follow-up of no more than 10%. The primary outcome will be studied through the dichotomous variable cognitive deterioration (0/1). Cognitive changes over the follow-up period will be analysed using the McNemar test. In addition, an analytical approach using logistic regression will be followed to identify patients at risk of cognitive deterioration. As a result, this analysis will obtain a frequency measurement: the odds ratio (OR). The specific objectives will be studied using bivariate analysis. Continuous contrast variables will be studied using the t-test or ANOVA and categorical variables will be studied using the chi- square test.</p><p><strong>Conclusions:</strong> The MEMOGAL study will provide information on safety in terms of cognitive deterioration in patients starting treatment with PCSK9 inhibitors.</p><p> </p> http://www.aulamedica.es/fh/pdf/11569.pdfalirocumabevolocumabpcsk9 inhibitorscholesterolcognitionlipid-lowering therapies |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
José Seijas-Amigo Diego Rodríguez-Penas Ana Estany-Gestal Pedro Suárez-Artime María Santamaría-Cadavid José Ramón González-Juanatey |
spellingShingle |
José Seijas-Amigo Diego Rodríguez-Penas Ana Estany-Gestal Pedro Suárez-Artime María Santamaría-Cadavid José Ramón González-Juanatey Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol Farmacia Hospitalaria alirocumab evolocumab pcsk9 inhibitors cholesterol cognition lipid-lowering therapies |
author_facet |
José Seijas-Amigo Diego Rodríguez-Penas Ana Estany-Gestal Pedro Suárez-Artime María Santamaría-Cadavid José Ramón González-Juanatey |
author_sort |
José Seijas-Amigo |
title |
Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol |
title_short |
Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol |
title_full |
Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol |
title_fullStr |
Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol |
title_full_unstemmed |
Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol |
title_sort |
observational multicentre prospective study to assess changes in cognitive function in patients treated with pcsk9i. study protocol |
publisher |
Grupo Aula Médica |
series |
Farmacia Hospitalaria |
issn |
1130-6343 2171-8695 |
publishDate |
2021-05-01 |
description |
<p><strong>Objective:</strong> PCSK9 inhibitors have been shown to reduce LDLc by up to about 60% and 85% when used with high doses of statins and
ezetimibe (2019 ESC/EAS Guidelines). These therapies may lead to very low levels of LDLc and have been associated with possible cognitive
deterioration. No significant differences were found in the only specific study (EBBINGHAUS). The objective is to prospectively evaluate cognitive
deterioration and its repercussion on quality of life and changes in LDLc in patients starting treatment with PCKS9
inhibitors.</p><p><strong>Method:</strong> It is a postauthorization, multicentre, non-randomized, prospective study. Patients starting treatment for the first
time with PCSK9 inhibitors will be recruited in 11 Galician Hospitals over a period of 12 months and with 24 months of follow-up. The primary outcome will be
to evaluate changes in cognitive function using the Montreal Cognitive Assessment (MOCA) questionnaire. The secondary outcome will be to evaluate
changes in quality of life using the EuroQol-5D. Changes in LDLc will be assessed. The sample size will be 275 patients, taking into <br />account a loss to
follow-up of no more than 10%. The primary outcome will be studied through the dichotomous variable cognitive deterioration (0/1). Cognitive changes over
the follow-up period will be analysed using the McNemar test. In addition, an analytical approach using logistic regression will be followed to identify patients
at risk of cognitive deterioration. As a result, this analysis will obtain a frequency measurement: the odds ratio (OR). The specific objectives will be studied
using bivariate analysis. Continuous contrast variables will be studied using the t-test or ANOVA and categorical variables will be studied using the chi-
square test.</p><p><strong>Conclusions:</strong> The MEMOGAL study will provide information on safety in terms of cognitive deterioration in patients
starting treatment with PCSK9 inhibitors.</p><p> </p>
|
topic |
alirocumab evolocumab pcsk9 inhibitors cholesterol cognition lipid-lowering therapies |
url |
http://www.aulamedica.es/fh/pdf/11569.pdf |
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