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.

Necesidades y experiencia farmacoterapéutica de los pacientes con leucemia mieloide crónica tratados con inhibidores de la tirosina cinasa: revisión sistemática / Medication experience and patient’s related needs in chronic myeloid leukemia treated with tyrosine kinase inhibitors: Systematic review

Objetivo: diversas investigaciones cuantitativas generan evidencia sobre los pacientes con leucemia mieloide crónica y el tratamiento activo con inhibidores tirosina cinasa, pero son escasas las investigaciones cualitativas que orienten sus resultados a cómo acompañar a los pacientes a lo largo de su enfermedad. El objetivo es conocer las expectativas, las necesidades de información y las experiencias condicionantes al usar inhibidores tirosina cinasa en los pacientes con leucemia mieloide crónica en los estudios cualitativos publicados en la literatura científica.Métodosse revisaron sistemáticamente investigaciones cualitativas publicadas entre 2003 y 2021 en Pubmed/Medline, Web of Science y Embase de pacientes con leucemia mieloide crónica tratados con inhibidores tirosina cinasa. Las palabras clave fueron «Leukemia, Myeloid» y «Qualitative Research». Se excluyeron artículos sobre la fase aguda o blástica.Resultadosse localizaron 184 publicaciones. Eliminando los duplicados, se incluyeron 6 (3%) y excluyeron 176 (97%). Los estudios muestran la enfermedad como inflexión en la vida de los pacientes, quienes desarrollan sus propias estrategias para controlar los efectos adversos. Los factores que determinan la experiencia farmacoterapéutica con inhibidores tirosina cinasa deben abordarse mediante estrategias personalizadas: esto permitiría la detección temprana de problemas, reforzaría la educación en cada etapa y promovería la discusión abierta sobre las causas complejas que subyacen al fracaso del tratamiento. (AU)

Objective: Several studies quantitatively described patients with Chronic Myeloid Leukaemia on active treatment with tyrosine kinase inhibitors, however there are few qualitative studies that focus their results on how to accompany patients in the course of the disease over time. The objective of this review is to find out what are the expectations, information needs and experiences that determine adherence to treatment with tyrosine kinase inhibitors in patients with Chronic Myeloid Leukaemia in qualitative research articles published in the scientific literature.MethodsA systematic review of qualitative research articles published between 2003-2021 was carried out in PubMed/Medline, Web of Science and Embase databases. Main keywords used were: "Leukaemia, Myeloid" and "Qualitative Research". Articles on the acute phase or blast phase were excluded.Results184 publications were located. After elimination of duplicates, 6 (3%) were included and 176 (97%) publications were excluded. Studies show that the illness is a turning point in patients' lives, and they develop their own strategies for managing the adverse effects. The factors that determine medication experiences with tyrosine kinase inhibitors should be addressed by implementing personalized strategies: this would result in early detection of problems, reinforce education at each stage and promote open discussion about complex causes underlying the treatment failure. (AU)

[Translated article] The needs and medication experience of patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors: A systematic review.

OBJECTIVE: Several studies quantitatively described patients with Chronic Myeloid Leukemia on active treatment with tyrosine kinase inhibitors, however there are few qualitative studies that focus their results on how to accompany patients in the course of the disease over time. The objective of this review is to find out what are the expectations, information needs and experiences that determine adherence to treatment with tyrosine kinase inhibitors in patients with Chronic Myeloid Leukemia in qualitative research articles published in the scientific literature. METHODS: A systematic review of qualitative research articles published between 2003-2021 was carried out in PubMed/Medline, Web of Science and Embase databases. Main keywords used were: "Leukemia, Myeloid" and "Qualitative Research". Articles on the acute phase or blast phase were excluded. RESULTS: 184 publications were located. After elimination of duplicates, 6 (3%) were included and 176 (97%) publications were excluded. Studies show that the illness is a turning point in patients' lives, and they develop their own strategies for managing the adverse effects. The factors that determine medication experiences with tyrosine kinase inhibitors should be addressed by implementing personalized strategies: this would result in early detection of problems, reinforce education at each stage and promote open discussion about complex causes underlying the treatment failure. CONCLUSIONS: This systematic review provides evidence that implementation personalized strategies must be done to adress the factors that determine the illness experience with Chronic Myeloid Leukemia and receiving treatment with tyrosine kinase inhibitors.

Medication experience and patient's related needs in chronic myeloid leukemia treated with tyrosine kinase inhibitors: Systematic review. / Necesidades y experiencia farmacoterapéutica de los pacientes con leucemia mieloide crónica tratados con inhibidores de la tirosina cinasa: revisión sistemática.

OBJECTIVE: Several studies quantitatively described patients with Chronic Myeloid Leukaemia on active treatment with tyrosine kinase inhibitors, however there are few qualitative studies that focus their results on how to accompany patients in the course of the disease over time. The objective of this review is to find out what are the expectations, information needs and experiences that determine adherence to treatment with tyrosine kinase inhibitors in patients with Chronic Myeloid Leukaemia in qualitative research articles published in the scientific literature. METHODS: A systematic review of qualitative research articles published between 2003-2021 was carried out in PubMed/Medline, Web of Science and Embase databases. Main keywords used were: "Leukaemia, Myeloid" and "Qualitative Research". Articles on the acute phase or blast phase were excluded. RESULTS: 184 publications were located. After elimination of duplicates, 6 (3%) were included and 176 (97%) publications were excluded. Studies show that the illness is a turning point in patients' lives, and they develop their own strategies for managing the adverse effects. The factors that determine medication experiences with tyrosine kinase inhibitors should be addressed by implementing personalized strategies: this would result in early detection of problems, reinforce education at each stage and promote open discussion about complex causes underlying the treatment failure. CONCLUSIONS: This systematic review provides evidence that implementation personalized strategies must be done to adress the factors that determine the illness experience with Chronic Myeloid Leukaemia and receiving treatment with tyrosine kinase inhibitors.

Impact of a pharmaceutical intervention on influenza vaccination in patients receiving treatment with biological medicines.

OBJECTIVE: The aims of this study were twofold - to determine the impact of a health education intervention led by a hospital pharmacy department on influenza vaccination take-up in patients diagnosed with immune-mediated diseases. Patients were receiving treatment with biological medicines. Secondly, to compare those rates with the vaccination percentages of another hospital pharmacy with similar characteristics in which no educational intervention was conducted. METHODS: This was a retrospective cohort study of adult patients with immune-mediated diseases receiving treatment with biological medicines. The medicines were dispensed by the hospital pharmacy departments of two hospitals between 1 January 2019 and 31 December 2020. In Cohort A (intervention group), a health education strategy was implemented with regards to influenza vaccination. Cohort B acted as a control group. The influenza vaccination rates obtained in both cohorts during 2019 and 2020 were compared. RESULT: A total of 355 patients took part in the study - 148 (41.7%) in Cohort A and 207 (58.3%) in Cohort B. The hospital pharmacy department in Cohort A implemented a health education strategy after which the vaccination percentage during the 2020 campaign increased by 38 patients (45.7%), compared with a 10 patient (5.8%) increase in Cohort B (p<0.001). CONCLUSIONS: The health intervention by the pharmacy department had a positive impact. This included an opportunity to improve vaccination take-up and is a strategy to consider when implementing a vaccination programme. Health education is a fundamental objective of healthcare. In our case it led to an increase in vaccination and had a positive impact on public health. It also provides opportunities for pharmacists to work in a multidisciplinary way with other healthcare professionals.

Angiosarcoma epitelioide tiroideo no alpino en una mujer anciana / Nonalpine epithelioid angiosarcoma of the thyroid in an old woman

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