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| ID | Type | Description | Link |
|---|---|---|---|
| 2019/653 | Other Identifier | CEIm-G | |
| PMID: 33941059 | Other Identifier | pubmed |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncontrolled patients with hypercholesterolemia | Patients that meet criteria inclusions and they have just started to take Alirocumab or Evolocumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 inhibitor | Drug | Patients are included after PCSK9 inhibitors prescription , at the first dispensation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterol values | LDL-cholesterol changes will be assessed during the study by routine sample tests (mg/dL) | 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/ |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Total cholesterol evolution during the study in mg/dL | 24 to 36 months |
| Lp(a) | Lp(a) evolution during the study in mg/dL | 24 to 36 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with familial hypercholesterolemia (homozygous and heterozygous) and/or cardiovascular disease with LDL-cholestrol value > 100 mg/dL and maximum statine doses or intolerance. With a first prescription of PCSK9 inhibitors
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Virxen da Xunqueira de Cee | Cee | A Coruña | Spain | |||
| Hospital Arquiteto Marcide de Ferrol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28813214 | Background | Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131. | |
| 30403574 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2023 | |
| Reset | Mar 7, 2024 | |
| Release | Apr 29, 2024 | |
| Reset | Sep 13, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2023 | Mar 7, 2024 | |||
| Apr 29, 2024 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 24 to 36 months |
| Direct costs | Direct costs related with treatments and consultations (€) | 24 to 36 months |
| Cost-effectiveness | €/QUALY | 24 to 36 months |
| 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 | 15706 | Spain |
| Hospital Lucus-Augusti de Lugo | Lugo | Spain |
| Complejo Hospitalario Universitario de Ourense | Ourense | Spain |
| Complexo Hospitalario Universitario de Pontevedra | Pontevedra | Spain |
| Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Quintero K, Roe MT, Sasiela WJ, Tamby JF, Tricoci P, White HD, Zeiher AM; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018 Nov 29;379(22):2097-2107. doi: 10.1056/NEJMoa1801174. Epub 2018 Nov 7. |
| 28304224 | Background | Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17. |
| 26926598 | Background | Kolodziejczak M, Navarese EP. Role of PCSK9 antibodies in cardiovascular disease: Critical considerations of mortality and neurocognitive findings from the current literature. Atherosclerosis. 2016 Apr;247:189-92. doi: 10.1016/j.atherosclerosis.2016.02.011. Epub 2016 Feb 15. |
| 26578202 | Background | Lipinski MJ, Benedetto U, Escarcega RO, Biondi-Zoccai G, Lhermusier T, Baker NC, Torguson R, Brewer HB Jr, Waksman R. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary hypercholesterolaemia: a network meta-analysis. Eur Heart J. 2016 Feb 7;37(6):536-45. doi: 10.1093/eurheartj/ehv563. Epub 2015 Nov 17. |
| 16314752 | Background | Shibata N, Ohnuma T, Higashi S, Higashi M, Usui C, Ohkubo T, Watanabe T, Kawashima R, Kitajima A, Ueki A, Nagao M, Arai H. No genetic association between PCSK9 polymorphisms and Alzheimer's disease and plasma cholesterol level in Japanese patients. Psychiatr Genet. 2005 Dec;15(4):239. doi: 10.1097/00041444-200512000-00004. No abstract available. |
| 26944571 | Background | Xue-Shan Z, Juan P, Qi W, Zhong R, Li-Hong P, Zhi-Han T, Zhi-Sheng J, Gui-Xue W, Lu-Shan L. Imbalanced cholesterol metabolism in Alzheimer's disease. Clin Chim Acta. 2016 May 1;456:107-114. doi: 10.1016/j.cca.2016.02.024. Epub 2016 Mar 2. |
| 27865998 | Background | Banach M, Rizzo M, Nikolic D, Howard G, Howard V, Mikhailidis D. Intensive LDL-cholesterol lowering therapy and neurocognitive function. Pharmacol Ther. 2017 Feb;170:181-191. doi: 10.1016/j.pharmthera.2016.11.001. Epub 2016 Nov 16. |
| 29562810 | Background | Paquette M, Saavedra YGL, Poirier J, Theroux L, Dea D, Baass A, Dufour R. Loss-of-Function PCSK9 Mutations Are Not Associated With Alzheimer Disease. J Geriatr Psychiatry Neurol. 2018 Mar;31(2):90-96. doi: 10.1177/0891988718764330. Epub 2018 Mar 21. |
| 28153102 | Background | Robinson JG, Rosenson RS, Farnier M, Chaudhari U, Sasiela WJ, Merlet L, Miller K, Kastelein JJ. Safety of Very Low Low-Density Lipoprotein Cholesterol Levels With Alirocumab: Pooled Data From Randomized Trials. J Am Coll Cardiol. 2017 Feb 7;69(5):471-482. doi: 10.1016/j.jacc.2016.11.037. |
| 33941059 | Background | Seijas-Amigo J, Rodriguez-Penas D, Estany-Gestal A, Suarez-Artime P, Santamaria-Cadavid M, Gonzalez-Juanatey JR. Observational multicentre prospective study to assess changes in cognitive function in patients treated with PCSK9i. Study protocol. Farm Hosp. 2021 Mar 5;45(3):150-154. doi: 10.7399/fh.11569. |
| 35287972 | Background | Seijas-Amigo J, Gayoso-Rey M, Mauriz-Montero MJ, Suarez-Artime P, Casas-Martinez A, Dominguez-Guerra M, Gonzalez-Freire L, Estany-Gestal A, Codero-Fort A, Rodriguez-Manero M, Gonzalez-Juanatey JR; e investigadores MEMOGAL. Impact of the COVID-19 pandemic in the lipid control of the patients that start PCSK9 inhibitors. Clin Investig Arterioscler. 2022 Sep-Oct;34(5):245-252. doi: 10.1016/j.arteri.2022.01.003. Epub 2022 Feb 3. English, Spanish. |
| 39452487 | Derived | Seijas-Amigo J, Mauriz-Montero MJ, Suarez-Artime P, Gayoso-Rey M, Reyes-Santias F, Estany-Gestal A, Casas-Martinez A, Gonzalez-Freire L, Rodriguez-Vazquez A, Perez-Rodriguez N, Villaverde-Pineiro L, Castro-Rubinos C, Espino-Paisan E, Cordova-Arevalo O, Rodriguez-Penas D, Cardeso-Paredes B, Ribeiro-Ferreiro M, Rodriguez-Manero M, Cordero A, Gonzalez-Juanatey JR, Memogal Investigators. Cost-Utility Analysis of PCSK9 Inhibitors and Quality of Life: A Two-Year Multicenter Non-Randomized Study. Diseases. 2024 Oct 5;12(10):244. doi: 10.3390/diseases12100244. |
| 37612529 | Derived | Seijas-Amigo J, Mauriz-Montero MJ, Suarez-Artime P, Gayoso-Rey M, Estany-Gestal A, Casas-Martinez A, Gonzalez-Freire L, Rodriguez-Vazquez A, Perez-Rodriguez N, Villaverde-Pineiro L, Castro-Rubinos C, Espino-Faisan E, Rodriguez-Manero M, Cordero A, Gonzalez-Juanatey JR; Investigadores MEMOGAL. Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study. Am J Cardiovasc Drugs. 2023 Sep;23(5):583-593. doi: 10.1007/s40256-023-00604-6. Epub 2023 Aug 23. |
| Sep 13, 2024 |
| D009750 |
| Nutritional and Metabolic Diseases |