The main objective will be to evaluate the changes in the cognitive function in naive patients treated with PCSK9 inhibitors (Alirocumab and Evolocumab) by using the Montreal Cognitive Assesment questionnaire (MOCA). The secondary objectives will be: 1) To evaluate the levels of LDL-cholesterol changes from the beginning to the end of the study 2) To evaluate changes in Quality of Life among the EuroQol EQ-5D-3L questionnaire (it will also be associated to the cognitive function) 3) Assesment of direct costs in medications and outpatients consultations related with the health procedures.
Study Type
OBSERVATIONAL
Enrollment
180
Patients are included after PCSK9 inhibitors prescription , at the first dispensation
Hospital de Virxen da Xunqueira de Cee
Cee, A Coruña, Spain
Hospital Arquiteto Marcide de Ferrol
Ferrol, A Coruña, Spain
Hospital del Barbanza
Ribeira, A Coruña, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Público da Mariña de Burela
Burela de Cabo, Lugo, Spain
Hospital de Monforte
Monforte de Lemos, Lugo, Spain
Hospital do Barco de Valdeorras
O Barco de Valdeorras, Ourense, Spain
Hospital Alvaro Cunqueiro de Vigo
Vigo, Pontevedra, Spain
Complejo Hospitalario Universitario de A Coruña
A Coruña, Spain
Hospital Lucus-Augusti de Lugo
Lugo, Spain
...and 2 more locations
Changes in cognitive function
Assesment by Montreal Cognitive Assessment questionnaire (MOCA). Minimum value is 0 and maximum value is 30. A higher or equal value to 26 points will be considered normal.
Time frame: 24 to 36 months
LDL-cholesterol values
LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL)
Time frame: 24 to 36 months
Changes in Quality of life
By using the questionnaire called EuroQol EQ-5D-3L assessment. It has 2 parts, the first one has 5 questions with 3 possible answers (5 dimensions and 3 levels), so each health status has a rate called EVA from 1,0000 (the highest value) to - 0,5095 (the worst health status). The second part is a visual self-assessment between 0 (the worst health status) and 100 (the best health status). https://euroqol.org/
Time frame: 24 to 36 months
Direct costs
Direct costs related with treatments and consultations (€)
Time frame: 24 to 36 months
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