Abstract Objective Traumatic brain injury (TBI) is associated with a number of cognitive deficits. Language factors also impact neurocognitive performance. We examined the effects of TBI and bilingualism/monolingualism on a test of attention and executive functioning (Trail Making Test; TMT). Method The sample (N = 96) consisted of 36 healthy controls (19 bilingual; 17 monolingual), 34 acute TBI participants (12 bilingual; 21 monolingual), and 27 chronic TBI participants (16 bilingual; 11 monolingual). Acute TBI participants were tested 6 months post-injury and chronic TBI participants were tested 12 months or more post-injury. 3X2 ANOVAs were conducted to determine the effect of TBI and bilingualism/monolingualism on TMT part A and B. Results Main effects were found between groups (i.e., control and TBI groups) on TMT A, p < .001, ηp² = .17 and TMT B, p < .05, ηp² = .09. Pairwise comparisons revealed a difference only between the control group and the 6-month TBI group, with the latter performing worse. Main effects were found for bilingualism/monolingualism on TMT A, p < .05, ηp² = .04 and TMT B, p < .05, ηp² = .05; monolingual participants performed better than bilingual participants. No interactions emerged. Conclusion Relative to monolinguals, bilingual participants demonstrated worse attention and executive functioning performances 6 months post-TBI; however, 12 months post-TBI, the difference was negligible.
Circulating osteogenic precursor (COP) cells are peripheral blood cells with a capacity for osteogenesis. The objective of our study was to ascertain the percentage of COPs as an early biomarker of osteoporosis and the effect of these cells in response to Denosumab (DmAb) (anti-resorptive) or to Teriparatide (TPDP) (anabolic) as very effective drugs in the treatment of the illness. A first study was conducted on healthy volunteers, with three age ranges, to determine the percentage of COPs and relate it to their anthropometric and biochemical characteristics, followed by a second longitudinal study on patients with osteoporosis, whereby one group of patients was treated with TPTD and another with DmAb. All were analyzed by cytometry for COP percentage in blood, bone turnover markers, and bone mass. Our findings show that COPs are influenced by age and become more prolific in the stages of growth and skeletal maturation. A higher percentage of COPs is found in osteoporotic disease, which could constitute a predictive marker thereof. We also show how treatment with TPTD or DmAb mobilizes circulating osteogenic precursors in the blood. Significant increases in % COPs were observed after 12 months of treatment with Dmb (21.9%) and TPTD (17%). These results can be related to an increase in osteogenesis and, consequently, a better and more efficient repair of bone tissue.
Traumatic brain injury (TBI) is a leading cause of mortality and morbidity worldwide. Currently, there is no effective strategy to treat the functional sequelae associated with TBI. Experimental evidence shows that the intravenous administration of bone marrow stromal cells (BMSC) during the first week after TBI prevents neurological deficits, but no experimental studies have shown evidence of the effect of intravenous BMSC on chronic brain injury sequelae. Here we studied the effect of intravenous administration of BMSC on functional outcomes 2 months after experimental TBI in rats. Adult Wistar rats were subjected to weight-drop impact causing severe brain injury, and 2 months later BMSC in saline, or saline alone, was intravenously injected. All experimental groups were evaluated by means of the modified Neurological Severity Score (mNSS), and internal zone Permanence Time (izPT) after video-tracking box (VTB) analysis, over the following 2 months to test the efficacy of BMSC therapy. At the end of the study period the animals were sacrificed and their brains were studied to evaluate possible differences between groups. Two months after BMSC administration no significant differences were detected in the motor and sensory evaluation between animals treated with BMSC and controls, and no differences were detected after histological study of the brains. Our present results suggest that intravenous administration of BMSC after TBI, when the neurological deficits are well established, has no beneficial effect in neurological outcomes or on brain tissue.
Limited data exist on low-density lipoprotein-cholesterol (LDL-C) level variability or long-term persistence with the monoclonal antibody evolocumab in routine clinical practice. HEYMANS (NCT02770131) is the first multi-country, multicenter, observational study of European patients initiating evolocumab as part of their routine clinical management, based on local reimbursement criteria (overall data recently published). The aim of this analysis is to describe clinical characteristics, baseline and changes in LDL-C levels, treatment patterns and persistence to evolocumab over 30 months in the Spanish cohort using data from the HEYMANS Registry. HEYMANS was a prospective study of adult patients (≥18 years) who received at least one dose of evolocumab. A total of 1951 patients were enrolled from 12 countries and were followed up for 30 months after evolocumab initiation. Data were collected for 6 months before evolocumab initiation and up to 30 months thereafter. The Spanish cohort included patients who started evolocumab in routine clinical practice from March 2016 to September 2019. Demographic and clinical characteristics, lipid-lowering therapies (LLT), and lipid levels were collected. In total, 201 patients were included in the Spanish cohort. Median follow-up (Q1–Q3) was 30.0 (12–30) months. A total of 61.7% of patients were men and the mean (standard deviation) age was 59.5 (10.8) years. Most patients (68.7%) had experienced a prior cardiovascular event, 45.3% had coronary artery disease or stable angina, and 60.2% had a diagnosis of familial hypercholesterolemia. Overall, 57.7% of patients were receiving treatment with statins, most of them with high-intensity statins (85.3%); 45.8% of patients were intolerant to statins, and 26.4% of patients did not receive any LLT. At baseline, median (Q1–Q3) LDL-C levels were 151 (123–197) mg/dL. After 3 months of treatment, baseline LDL-C decreased by 66% to a median of 50 (30–83) mg/dL and these levels were maintained over time, with a median LDL-C of 55 (40–99) mg/dL at 30 months. At months 10–12 of treatment, LDL-C levels < 55 mg/dL were achieved by 56.3% of patients. LDL-C levels < 70 mg/dL were achieved by 70.1% of patients, and a lowering of LDL-C levels ≥50% was achieved by 76.8% of patients. The percentage of patients on evolocumab treatment was 95% at 12 months and 93% at 30 months. In the Spanish cohort in routine clinical practice, evolocumab therapy provided a reduction in LDL-C levels consistent with that reported in previous clinical trials, which was sustained during 30 months of follow-up. Treatment with evolocumab was started at LDL-C levels 50% higher than those recommended by The Spanish Society of Arteriosclerosis and the Therapeutic Positioning Report. The probability of achieving the 2019 ESC/EAS LDL-C goals would improve with combination therapy and also with a lower LDL-C threshold when starting evolocumab. Persistence to evolocumab remained high during follow-up, with a very low percentage of discontinuation (5% at 12 months; 7% at 30 months). Existen datos limitados sobre la variabilidad del nivel de colesterol de lipoproteínas de baja densidad (cLDL) o la persistencia a largo plazo con el anticuerpo monoclonal evolocumab en la práctica clínica habitual. HEYMANS (NCT02770131) es el primer estudio observacional multicéntrico y multinacional de pacientes europeos que iniciaron tratamiento con evolocumab en la práctica clínica habitual, basado en criterios de reembolso locales. El objetivo fue evaluar las características clínicas, los cambios en los niveles de cLDL, los patrones de tratamiento y la persistencia a este con evolocumab en la cohorte española con un seguimiento de 30 meses, utilizando datos del registro HEYMANS. HEYMANS fue un estudio prospectivo de pacientes adultos (≥18 años) que recibieron al menos una dosis de evolocumab prescrita. Se incluyeron 1.951 sujetos de 12 países. Los datos fueron recopilados desde los seis meses previos al inicio del tratamiento hasta los 30 meses posteriores. La cohorte española incluyó pacientes que comenzaron evolocumab en la práctica clínica habitual desde marzo del 2016 hasta septiembre del 2019. Se recogieron las características demográficas y clínicas, los tratamientos hipolipemiantes (LLT) y el perfil lipídico. En la cohorte española se incluyeron 201 participantes. La mediana de seguimiento (Q1-Q3) fue de 30,0 (12-30) meses. De los pacientes, 61,7% eran hombres, con edad media (desviación estándar) de 59,5 (10,8) años. La mayoría (68,7%) había presentado un evento cardiovascular previo, 45,3% padecía enfermedad arterial coronaria o angina estable y 60,2% tenía diagnóstico de hipercolesterolemia familiar. En general, 57,7% de los pacientes recibían tratamiento con estatinas, la mayoría con estatinas de alta intensidad (85,3%), 45,8% eran intolerantes a las estatinas y 26,4% no recibían LLT. Al inicio del estudio, la mediana (Q1-Q3) de los niveles de cLDL fue de 151 (123-197) mg/dL. A los tres meses de tratamiento, el cLDL basal disminuyó 66% hasta una mediana de 50 (30-83) mg/dL y se mantuvo en el tiempo, con una mediana de 55 (40-99) mg/dL a los 30 meses. A los 10-12 meses de terapia, 56,3% de los pacientes alcanzaron niveles de cLDL < 55 mg/dL y 70,1% < 70 mg/dL. Además, 76,8% de los pacientes lograron una reducción de ≥ 50%. El porcentaje de pacientes en tratamiento fue de 95% a los 12 meses y 93% a los 30 meses. En España, en práctica clínica habitual, el tratamiento con evolocumab redujo los niveles de cLDL, y estos se mantuvieron constantes durante el seguimiento, similar a lo previamente reportado. El régimen con evolocumab se inició con niveles de cLDL 50% superiores a los recomendados. La probabilidad de alcanzar los objetivos de cLDL de la ESC/EAS 2019 mejoraría con la terapia combinada y también con un umbral de cLDL más bajo al iniciar evolocumab. La persistencia al tratamiento con evolocumab se mantuvo alta durante el seguimiento, con un porcentaje muy bajo de discontinuidad (5% a los 12 meses; 7% a los 30 meses).