102 results on '"Arnaiz JA"'
Search Results
2. 5PSQ-074 Pharmaceutical interventions in pain management
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Cuy Bueno, M, primary, Gilabert Sotoca, M, additional, Bardoll Cucala, M, additional, Rius Perera, J, additional, Cano Marron, SM, additional, Martínez Sogues, M, additional, Nevot Blanc, M, additional, Mangues Bafalluy, I, additional, and Schoenenberger Arnaiz, JA, additional
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- 2024
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3. 4CPS-042 Overdose of darbepoetin in patients with chronic kidney failure. Room for improvement with pharmacist interventions
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Mir Cros, M, primary, Taberner Bonastre, P, additional, Bardoll Cucala, M, additional, Cuy Bueno, M, additional, Galindo Verdugo, A, additional, Torres Bondia, FI, additional, Cano Marrón, SM, additional, Sarró Sobrín, JF, additional, Craver Hospital, LS, additional, and Schoenenberger Arnaiz, JA, additional
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- 2024
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4. Informing primary care physicians of patients' involvement in clinical trials carried out at a specialist care level
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Schoenenberger-Arnaiz JA, Solanilla-Puertolas M, Acer-Puig M, and Gomez-Arbones J
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informed consent ,clinical trials ,family physician ,wallet card ,Medicine - Abstract
Joan Antoni Schoenenberger-Arnaiz,1,2 Montserrat Solanilla-Puertolas,2 Maria Acer-Puig,3 Javier Gomez-Arbones3,4 1Pharmacy Department, Arnau de Vilanova University Hospital, 2Institutional Review Board, Arnau de Vilanova University Hospital, 3Department of Medicine, Faculty of Medicine, University of Lleida, 4IRB Lleida, University of Lleida, Arnau de Vilanova University Hospital, Lleida, Spain Background: Patients enrolled in clinical trials continue to have frequent contacts with primary care physicians because of comorbidities or toxicities. The aim of the present study was to analyze the information provided at different levels, when participants are included in clinical trials organized at a specialized care level. The purpose was to verify if informing the patient’s primary care physician is contemplated in the inclusion process.Methods: The authors conducted a cross-sectional study that included the clinical trials approved in the last 2 years by the hospital’s Institutional Review Board. In addition, some of the participants in the included clinical trials were interviewed in order to check their knowledge of the type of research taking place.Results: In total, 67 protocols and the accompanying informed consent documents were reviewed. Half of the reviewed protocols (48%) did not provide participants with an identification card. Regarding the role of the primary care physician, 68.6% of clinical trials (46/67) had taken it into account in different ways. In only four trials, the method used to contact the primary care physician was documented. In total, 20 participants were interviewed. Only 3 (15%) knew the title of the study in which they were participating, 14 (70%) were aware of their illness and 6 (30%) did not know how to answer any of these two questions. Almost all participants in the study knew the name of the physician who was the principal investigator in the trial.Conclusion: Information given to health care practitioners, who are not directly involved in clinical trials conducted by specialized medical staff, is still scarce. In our clinical setting, patients participating in clinical trials have a low awareness of such studies. Keywords: informed consent, clinical trials, family physician, wallet card
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- 2017
5. 4CPS-109 Therapeutic drug monitoring of vancomycin in oncologic and haematologic patients: real-world data
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Bardoll Cucala, M, primary, Gilabert Sotoca, M, additional, Rius Perera, J, additional, Mangues Bafalluy, I, additional, Martinez Castro, B, additional, Mir Cros, M, additional, Morales Portillo, A, additional, and Schoenenberger Arnaiz, JA, additional
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- 2023
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6. 4CPS-189 Analysis of medication persistence in migraine patients treated with anti-CGRP monoclonal antibodies
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Mir Cros, M, primary, Torres Bondia, FI, additional, Cano Marrón, SM, additional, Taberner Bonastre, P, additional, Santos Rodriguez, C, additional, Morales Portillo, A, additional, Candeas Agusti, R, additional, Gonzalez Mingot, C, additional, Sanahuja Montesinos, J, additional, and Schoenenberger Arnaiz, JA, additional
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- 2023
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7. 4CPS-202 The usefulness of a pharmacy resident stage in the critical care unit
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Morales Portillo, A, primary, Mir Cros, M, additional, Bardoll Cucala, M, additional, Cuy Bueno, M, additional, Martínez Catro, B, additional, Martínez Sogues, M, additional, Nevot Blanc, M, additional, Santos Rodríguez, C, additional, Gilabert Sotoca, M, additional, and Schoenenberger Arnaiz, JA, additional
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- 2023
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8. 4CPS-083 Cost-effectiveness analysis of adalimumab and its clinical alternatives in immune-mediated inflammatory diseases in Spain
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Schoenenberger Arnaiz, JA, primary, Crespo Diz, C, additional, Martínez Sesmero, JM, additional, and Cerezales, M, additional
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- 2022
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9. 4CPS-112 Voriconazole therapeutic drug monitoring: relationship with liver toxicity
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Taberner Bonastre, P, primary, Aragones Eroles, A, additional, Martinez Sogues, M, additional, Martinez Castro, B, additional, Cano Marrón, SM, additional, Rivero Arango, E, additional, Almacellas Gomez, S, additional, Cao Baduell, G, additional, Gilabert Sotoca, M, additional, Ibarz Escuer, M, additional, and Schoenenberger Arnaiz, JA, additional
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- 2022
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10. The usefulness of Olanzapine plasma concentrations in monitoring treatment efficacy and metabolic disturbances in first-episode psychosis
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Arnaiz, JA, Rodrigues-Silva, C, Mezquida, G, Amoretti, S, Cuesta, MJ, Fraguas, D, Lobo, A, Gonzalez-Pinto, A, Diaz-Caneja, MC, Corripio, I, Vieta, E, Baeza, I, Mane, A, Garcia-Rizo, C, Bioque, M, Saiz, J, Bernardo, M, Mas, S, and PEPs Grp
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Drug level ,Efficacy ,Olanzapine ,Pharmacokinetics ,Therapeutic drug monitoring ,First-episode psychosis ,Weight gain - Abstract
Introduction The role of Olanzapine therapeutic drug monitoring is controversial. The present study explores the associations of Olanzapine plasma concentrations with clinical response and metabolic side effects in first episode psychosis (FEP) after 2 months of treatment. Methods Forty-seven patients were included. Improvement in clinical symptomatology was assessed using the PANSS. Metabolic assessment included weight, blood pressure, waist circumference, blood glucose, total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides. Results The Olanzapine plasma concentrations after 2 months of treatment were positively correlated with weight gain (r = 0.49, p = 0.003), and a concentration > 23.28 ng/mL was identified as a positive predictor of weight gain (>= 7%). The Olanzapine concentration to dose (C/D) ratio was positively correlated with the percentage of improvement in the total PANSS (r = 0.46, p = 0.004), and a C/D ratio > 2.12 was identified as a positive predictor of a good response (percentage of improvement > 30%) after 2 months of treatment. We also identified several factors that could alter Olanzapine pharmacokinetics: gender (p = 0.03), diagnosis (p = 0.05), smoking habit (p = 0.05), and co-medications such as valproic acid (p = 0.05) and anxiolytics (p = 0.01). Discussion In conclusion, our results suggest that therapeutic drug monitoring of Olanzapine could be helpful to evaluate therapeutic efficacy and metabolic dysfunction in FEP patients treated with Olanzapine.
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- 2021
11. Relación entre niveles plasmáticos de efavirenz y alteraciones lipémicas
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Aragonès Eroles,AM, Schoenenberger Arnaiz,JA, Cano Marrón,SM, Puig Ganau,T, Morales Portillo,A, and Manonelles Fernández,A
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dislipemia ,monitorización terapéutica de fármacos ,reacción adversa ,Efavirenz ,cromatografía - Abstract
RESUMEN El objetivo del presente trabajo es evaluar si existe relación entre los niveles plasmáticos de efavirenz y la aparición de dislipemia como hipercolesterolemia, hipretrigliceridemia o aumento de LDL-c. Se realizaron niveles plasmáticos de efavirenz a los pacientes en tratamiento con este fármaco desde septiembre de 2012 hasta junio de 2015. Se registraron los parámetros lipídicos correspondientes a cada analítica. Las determinaciones de efavirenz se realizaron mediante cromatografía líquida de alta eficacia. Los datos se manejaron mediante el programa Quick Statistics Calculator y Excel 2007. Los niveles plasmáticos de efavirenz superiores a 4.000 ng/ml se asocian en nuestro estudio con una mayor frecuencia de niveles de colesterol superiores a 200 mg/dl. Este estudio puede ser de utilidad para aquellas zonas en las que usen pautas de tratamiento con este fármaco de manera frecuente.
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- 2021
12. Determinación cualitativa de anidulafungina en líquidos de diálisis con administración intraperitoneal
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Taberner Bonastre,P, Aragonés Eroles,A, Martínez Castro,B, and Schoenenberger Arnaiz,JA
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diálisis ,Anidulafungina, peritoneal ,Candida glabrata - Abstract
RESUMEN La infección fúngica peritoneal es poco frecuente pero supone una elevada mortalidad. A pesar de que la principal recomendación es la retirada de catéter cuando se sospecha que es éste el foco de infección, hay ocasiones en las se requiere considerar otras opciones. La administración de anidulafungina intraperitoneal es una técnica sobre la que hay pocos estudios. Presentamos un caso clínico en el que administramos anidulafungina intraperitoneal y analizamos mediante técnica cualitativa la presencia del antifúngico en distintas muestras. Además, calculamos el porcentaje de reducción de anidulafungina entre el líquido de diálisis en el que la diluimos y este mismo tras permanecer 8 horas en la cavidad peritoneal.
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- 2021
13. 4CPS-284 Treatment of cyclin inhibitor induced neutropenia: impact on progression free survival
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Gilabert Sotoca, M, primary, Morales Murillo, S, additional, Mangues Bafalluy, I, additional, Ramos Gil, MA, additional, Morales Portillo, A, additional, Rius Perera, J, additional, and Schoenenberger Arnaiz, JA, additional
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- 2021
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14. 4CPS-244 Therapeutic drug monitoring guided pharmacy interventions to optimise the dosage of beta-lactams administered in continuous infusion in non-critically ill patients
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Aragones Eroles, AM, primary, Taberner Bonastre, P, additional, Schoenenberger Arnaiz, JA, additional, Bellés Bellés, A, additional, Cano Marrón, SM, additional, Morales Portillo, A, additional, and Jover Saenz, A, additional
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- 2021
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15. Association study of candidate genes with obesity and metabolic traits in antipsychotic-treated patients with first-episode psychosis over a 2-year period
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Gasso, P, Arnaiz, JA, Mas, S, Lafuente, A, Bioque, M, Cuesta, MJ, Diaz-Caneja, CM, Garcia, C, Lobo, A, Gonzalez-Pinto, A, Parellada, M, Corripio, I, Vieta, E, Castro-Fornieles, J, Mane, A, Rodriguez, N, Bolac, D, Saiz-Ruiz, J, Bernardo, M, Mezquida, G, Amoretti, S, Pina-Camacho, L, Gonzalez-Penas, J, Alonso-Solis, A, Rabetla, M, Zorrilla, I, Garcia, S, Barcones, F, Modrego, P, Sanjuan, J, Nacher, J, Berge, D, Monserrat, C, Verdolini, N, Gil-Badenes, J, Baeza, I, de la Serna, E, Contreras, F, Saiz-Masvidal, C, Garcia-Portilla, MP, Bobes, J, Gutierrez, M, Segarra, R, Dompablo, M, Rodriguez-Jimenez, R, Usall, J, Butjosa, A, Sarro, S, Pomarol-Clotet, E, Ibanez, A, Ribeiro, M, and Selva-Vera, G
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Antipsychotic ,obesity ,first episode of psychosis ,gene ,side-effect ,polymorphism - Abstract
Aims: Patients with a first episode of psychosis (FEP) often display different metabolic disturbances even independently of drug therapy. However, antipsychotic (AP) treatment, especially with second-generation APs, is strongly linked to weight gain, which increases patients' risk of developing obesity and other metabolic diseases. There is an important genetic risk component that can contribute to the appearance of these disturbances. The aim of the present study was to evaluate the effect of polymorphisms in selected candidate genes on obesity and other anthropometric and metabolic traits in 320 AP-treated FEP patients over the course of a 2-year follow-up. Methods: These patients were recruited in the multicentre PEPs study (Phenotype-genotype and environmental interaction; Application of a predictive model in first psychotic episodes). A total of 127 validated single nucleotide polymorphisms (SNPs) in 18 candidate genes were included in the genetic analysis. Results: After Bonferroni correction, SNPs in ADRA2A, FTO, CNR1, DRD2, DRD3, LEPR and BDNF were associated with obesity, abdominal circumference, triglycerides, HDL cholesterol, and/or percentage of glycated haemoglobin. Conclusions: Although our results should be interpreted as exploratory, they support previous evidence of the impact of these candidate genes on obesity and metabolic status. Further research is required to gain a better knowledge of the genetic variants that can be considered relevant metabolic risk factors. The ability to identify FEP patients at higher risk for these metabolic disturbances would enable clinicians to better select and control their AP treatment.
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- 2020
16. 5PSQ-034 Evaluation of oseltamivir use in clinical practice in a second level hospital
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Taberner Bonastre, P, primary, Rodriguez, Á Casinos, additional, Vállez Valero, L, additional, Cano Marrón, M, additional, Martinez Sogues, M, additional, Martinez Castro, B, additional, and Schoenenberger Arnaiz, JA, additional
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- 2020
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17. 3PC-037 Sterility of single use vials when accessed using a closed system transfer device
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Schoenenberger Arnaiz, JA, primary, Nevot-Blanc, M, additional, Moroba-Estor, A, additional, Gonzalez-Garcia, M, additional, Martinez-Sogues, M, additional, and Gilabert-Sotoca, M, additional
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- 2020
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18. 2SPD-001 Describing a thickener home delivery protocol and the benefits of its implementation
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Taberner Bonastre, P, primary, Tomas Sanchez, M, additional, Gallart Lopez, M, additional, Molins Giribet, I, additional, and Schoenenberger Arnaiz, JA, additional
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- 2019
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19. 5PSQ-042 Modification on fasting lipid and renal parameters in patients switching from tenofovir disoproxil to tenofovir alafenamide
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Taberner Bonastre, P, primary, Vallez Valero, L, additional, Cano Marrón, SM, additional, Puig Ganau, T, additional, Amoros Folguera, B, additional, Torres Bondia, FI, additional, and Schoenenberger Arnaiz, JA, additional
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- 2019
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20. Phase I clinical trial of an intranodally administered mRNA-based therapeutic vaccine against HIV-1 infection
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Leal, L, Guardo, AC, Moron-Lopez, S, Salgado, M, Mothe, B, Heirman, C, Pannus, P, Vanham, G, Ham, Henk-Jan, Gruters, Rob, Andeweg, Arno, van Meirvenne, S, Pich, J, Arnaiz, JA, Gatell, JM, Brander, C, Thielemans, K, Martinez-Picado, J, Plana, M, Garcia, F, Leal, L, Guardo, AC, Moron-Lopez, S, Salgado, M, Mothe, B, Heirman, C, Pannus, P, Vanham, G, Ham, Henk-Jan, Gruters, Rob, Andeweg, Arno, van Meirvenne, S, Pich, J, Arnaiz, JA, Gatell, JM, Brander, C, Thielemans, K, Martinez-Picado, J, Plana, M, and Garcia, F
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- 2018
21. Safety and vaccine-induced HIV-1 immune responses in healthy volunteers following a late MVA-B boost 4 years after the last immunization
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Guardo AC, Gómez CE, Vicens Diaz de Brito Fernandez, Pich J, Arnaiz JA, Perdiguero B, García-Arriaza J, González N, Sorzano COS, Jiménez L, Jiménez JL, Muñoz-Fernández MÁ, Gatell JM, Alcamí J, Esteban M, López Bernaldo de Quirós JC, García F, Plana M, and RISVAC02boost study
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viruses ,complex mixtures - Abstract
We have previously shown that an HIV vaccine regimen including three doses of HIV-modified vaccinia virus Ankara vector expressing HIV-1 antigens from clade B (MVA-B) was safe and elicited moderate and durable (1 year) T-cell and antibody responses in 75% and 95% of HIV-negative volunteers (n = 24), respectively (RISVAC02 study). Here, we describe the long-term durability of vaccine-induced responses and the safety and immunogenicity of an additional MVA-B boost.
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- 2017
22. 4CPS-086 Proposal to darunavir (drv) the least trough plasma level (tpl) cut-off to estimate plasma hiv viral load (hvl) equal or less than 20 copies/ml
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Saavedra, FJ Parada, primary, Bondia, FI Torres, additional, Eroles, A Aragonés, additional, Marrón, SM Cano, additional, Valero, L Vállez, additional, Sotoca, M Gilabert, additional, and Arnaiz, JA Schoenenberger, additional
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- 2018
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23. 5PSQ-064 Use of sorafenib in cellular hepatocarcinoma in routine clinical practice
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Saavedra, FJ Parada, primary, Agustí, R Candeas, additional, Calafat, JM Miñana, additional, Blanch, CL Aracil, additional, Sotoca, M Gilabert, additional, and Arnaiz, JA Schoenenberger, additional
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- 2018
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24. 5PSQ-115 Computerised physician order entry impact on medication errors in a paediatric unit
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Sotoca, M Gilabert, primary, Saavedra, FJ Parada, additional, Castro, B Martínez, additional, Sogues, M Martínez, additional, Valero, L Vállez, additional, and Arnaiz, JA Schoenenberger, additional
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- 2018
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25. Maraviroc, as a switch option, in HIV-1-infected individuals with stable, well-controlled HIV replication and R5-tropic virus on their first Nucleoside/Nucleotide reverse transcriptase inhibitor plus ritonavir-boosted protease inhibitor regimen: Week 48 Results of the randomized, multicenter March study
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Pett, SL, Amin, J, Horban, A, Andrade-Villanueva, J, Losso, M, Porteiro, N, Madero, JS, Belloso, W, Tu, E, Silk, D, Kelleher, A, Harrigan, R, Clark, A, Sugiura, W, Wolff, M, Gill, J, Gatell, J, Fisher, M, Clarke, A, Ruxrungtham, K, Prazuck, T, Kaiser, R, Woolley, I, Arnaiz, JA, Cooper, D, Rockstroh, JK, Mallon, P, Emery, S, Pett, SL, Amin, J, Horban, A, Andrade-Villanueva, J, Losso, M, Porteiro, N, Madero, JS, Belloso, W, Tu, E, Silk, D, Kelleher, A, Harrigan, R, Clark, A, Sugiura, W, Wolff, M, Gill, J, Gatell, J, Fisher, M, Clarke, A, Ruxrungtham, K, Prazuck, T, Kaiser, R, Woolley, I, Arnaiz, JA, Cooper, D, Rockstroh, JK, Mallon, P, and Emery, S
- Abstract
Background. Alternative combination antiretroviral therapies in virologically suppressed human immunodeficiency virus (HIV)-infected patients experiencing side effects and/or at ongoing risk of important comorbidities from current therapy are needed. Maraviroc (MVC), a chemokine receptor 5 antagonist, is a potential alternative component of therapy in those with R5-tropic virus. Methods. The Maraviroc Switch Study is a randomized, multicenter, 96-week, open-label switch study in HIV type 1-infected adults with R5-tropic virus, virologically suppressed on a ritonavir-boosted protease inhibitor (PI/r) plus double nucleoside/nucleotide reverse transcriptase inhibitor (2 N(t)RTI) backbone. Participants were randomized 1:2:2 to current combination antiretroviral therapy (control), or replacing the protease inhibitor (MVC + 2 N(t)RTI arm) or the nucleoside reverse transcriptase inhibitor backbone (MVC + PI/r arm) with twice-daily MVC. The primary endpoint was the difference (switch minus control) in proportion with plasma viral load (VL) <200 copies/mL at 48 weeks. The switch arms were judged noninferior if the lower limit of the 95% confidence interval (CI) for the difference in the primary endpoint was < -12% in the intention-to-treat (ITT) population. Results. The ITT population comprised 395 participants (control, n = 82; MVC + 2 N(t)RTI, n = 156; MVC + PI/r, n = 157). Baseline characteristics were well matched. At week 48, noninferior rates of virological suppression were observed in those switching away from a PI/r (93.6% [95% CI, -9.0% to 2.2%] and 91.7% [95% CI, -9.6% to 3.8%] with VL <200 and <50 copies/mL, respectively) compared to the control arm (97.6% and 95.1% with VL <200 and <50 copies/mL, respectively). In contrast, MVC + PI/r did not meet noninferiority bounds and was significantly inferior (84.1% [95% CI, -19.8% to -5.8%] and 77.7% [95% CI, -24.9% to -8.4%] with VL <200 and <50 copies/mL, respectively) to the control arm in the ITT analysis. Conclusions
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- 2016
26. Continued indinavir versus switching to indinavir/ritonavir in HIV-infected patients with suppressed viral load.
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Arnaiz, JA, Mallolas, J, Podzamczer, D, Gerstoft, J, Lundgren, Jens Dilling, Cahn, P, Fätkenheuer, G, Monforte, A D´Arminio, Casiró, A, Reiss, P, Burger, DM, Stek, M, Gatell, JM, Arnaiz, JA, Mallolas, J, Podzamczer, D, Gerstoft, J, Lundgren, Jens Dilling, Cahn, P, Fätkenheuer, G, Monforte, A D´Arminio, Casiró, A, Reiss, P, Burger, DM, Stek, M, and Gatell, JM
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- 2003
27. Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts
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De Lazzari, E, primary, León, A, additional, Arnaiz, JA, additional, Martinez, E, additional, Knobel, H, additional, Negredo, E, additional, Clotet, B, additional, Montaner, J, additional, Storfer, S, additional, Asenjo, MA, additional, Mallolas, J, additional, Miró, JM, additional, and Gatell, JM, additional
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- 2008
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28. PMD9 OPTIMIZATION OF AIDS PILOT CLINICAL TRIAL USING LEAMSIM
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Monleon, T, primary, Ocanña, J, additional, Vegas, E, additional, Fonseca, P, additional, Abbas, I, additional, Casanovas, J, additional, Cobo, E, additional, Arnaiz, JA, additional, Carné, X, additional, and Gatell, JM, additional
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- 2003
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29. 5PSQ-115 Computerised physician order entry impact on medication errors in a paediatric unit
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Sotoca, M Gilabert, Saavedra, FJ Parada, Castro, B Martínez, Sogues, M Martíínez, Valero, L Vííállez, and Arnaiz, JA Schoenenberger
- Abstract
BackgroundPaediatric patients involve certain complexities that make them vulnerable to medication errors and adverse patient outcomes. Most of the medication errors occur at the stage of physician ordering and they are often dosing errors. Computerised Physician Order Entry (CPOE) results in legible, structured and complete prescriptions. Furthermore, there is an improvement in the communication between physicians, nurses and pharmacists compared with handwritten orders.PurposeThe objective of this study was to evaluate the impact of CPOE on the frequency of errors in the medication ordering process in a paediatric unit.Material and methodsA prospective observational study was conducted in a 30-bed paediatric unit of a tertiary teaching hospital. The physician’s orders were reviewed for 2 months before and 2 months after CPOE implementation. Medication errors were identified and classified into errors of: dosing, interval, units, route of administration, treatment duration, schedule, wrong drug, incomplete order and rule violation.ResultsA total of 1164 orders of 212 patients were reviewed. Before implementation, medication errors occurred at a rate of 3.3 per 100 orders (n=20): 35% (n=7) were dosing errors, 25% (n=5) incomplete orders and 20% (n=4) unit errors. After implementation, the rate was increased to 6.6 per 100 orders (n=37): 24.3% (n=9) were dosing errors, 18.9% (n=7) rule violations, 18.9% (n=7) wrong treatment duration, 13.5% (n=5) schedule errors, 20% (n=4) unit errors and 8.1% (n=3) interval errors.ConclusionThe implementation of CPOE resulted in an increase in the number of medication errors, but the type of them was clearly different. While handwritten errors were the result of calculation errors, missing information or confusion in writing, CPOE errors were mainly due to the inexperience of using the program. The consequences of the CPOE errors were less harmful than handwritten prescription errors.No conflict of interest
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- 2018
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30. Effects of milk supplementation with conjugated linoleic acid (isomers cis-9, trans-11 and trans-10, cis-12) on body composition and metabolic syndrome components.
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Laso N, Brugué E, Vidal J, Ros E, Arnaiz JA, Carné X, Vidal S, Mas S, Deulofeu R, and Lafuente A
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- 2007
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31. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection.
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Martínez E, Arnaiz JA, Podzamczer D, Dalmau D, Ribera E, Domingo P, Knobel H, Riera M, Pedrol E, Force L, Llibre JM, Segura F, Richart C, Cortés C, Javaloyas M, Aranda M, Cruceta A, de Lazzari E, Gatell JM, and Abacavir (NEFA) Study Team
- Published
- 2003
32. 4CPS-086 Proposal to darunavir (drv) the least trough plasma level (tpl) cut-off to estimate plasma hiv viral load (hvl) equal or less than 20 copies/ml
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Saavedra, FJ Parada, Bondia, FI Torres, Eroles, A Aragonés, Marréón, SM Cano, Valero, L Véóállez, Sotoca, M Gilabert, and Arnaiz, JA Schoenenberger
- Abstract
BackgroundDarunavir (DRV) is a high genetic barrier protease inhibitor, which when it is combined with a booster drug such as ritonavir or cobicistat, has shown high effectiveness in wild types such as resistant strains of HIV. The lack of conclusive population studies has determined a consensual cut-off level using the IC50, which in its wild type is 55 mcg/l and in resistant strains is 550 mcg/l.PurposeTo find our TPL of DRV from which below this cut-off we can estimate HVL >20 copies/ml.Material and methodsOur prospective observational study included 51 HIV patients in treatment with the HAART scheme tenofovir disoproxil fumarate +emtricitabine + DRV 800 mg once a day (QD) for at least 4 months, registered previously with some drug-related problem (DRP) (non-compliance suspicion, drug adverse events and persistent or first positive viral loads during HAART scheme). One hundred and twenty TPL were collected and determined by high performance liquid chromatography (HPLC) and with the same samples also were also determined HVL by real-time polymerase chain reaction assay (rtPCR). Patients who needed more than one sample period between sampling were 1 month. We divided all the TPL in two groups, where 1000 mcg/l was a random cut-off. In each group, we established the proportion of patients with HVL >20 copies/ml.ResultsTwenty-six samples were included in group 1 (TPL <1000 mcg/L) and 94 in group 2 (TPL >1000 ng/ml). Samples related to HVL >20 copies/ml were 23 from group 1 (88.5%) and 58 from group 2 (61.7%). The proportional difference between this high HVL in both groups were statistically significant (Chi-square test p<0. 05). The relative risk to have HVL >20 copies/ml was 1.43 (95% CI: 1.16 to 1.77) in favour of group 1.ConclusionPatients with TPL <1000 mcg/L could have a major risk of therapeutic failure measured by HVL >20 copies/ml. We need to increase the size of population in this study to confirm this cut-off.No conflict of interest
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- 2018
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33. 5PSQ-064 Use of sorafenib in cellular hepatocarcinoma in routine clinical practice
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Saavedra, FJ Parada, Agustí, R Candeas, Calafat, JM Miíñana, Blanch, CL Aracil, Sotoca, M Gilabert, and Arnaiz, JA Schoenenberger
- Abstract
BackgroundSorafenib is a multikinase inhibitor approved for the treatment of hepatocellular carcinoma (HCC). In clinical trials sorafenib treatment resulted in a median overall survival of 9.2 months and a median time to progression of 5.5 months (SHARP study).PurposeTo describe the results of sorafenib treatment for HCC in terms of progression-free survival (PFS), toxicity and compliance in clinical practice.Material and methodsRetrospective, descriptive, real-world data-based study including patients with HCC treated with sorafenib between January 2011 and May 2017 at a regional reference hospital.Initial registered variables: age, sex, Child–Pugh status.Follow-up variables: discontinuation and reason of discontinuation (progression, death, worsening of clinical condition, unacceptable toxicity, lack of adherence, patient decision, loss of follow-up).Median PFS and PFS at 1 year were measured.All the data was extracted from the clinical practice registries: electronic clinical records (SAP®) and pharmacy dispensation records (Silicon®). The statistical data was obtained from the SPSS®program applying Kaplan–Meier analysis.ResultsA total of 55 patients aged 63.4±14 were included (85% males). Child–Pugh score was A, B or C in 35 (64%), 14 (25%) and six (11%) patients respectively. Twenty-two of them (40%) were excluded from the follow-up analysis because they did not reach a minimum of 45 days of treatment: nine (16%) presented unacceptable toxicity, seven (13%) died prematurely, four (7%) worsened their clinical condition and two (4%) were lost. The most frequent toxicity was asthaenia 18/55 (32.7%)Among the remaining 33 patients, 16 (48.5%) stopped the treatment for death, six (18.2%) for unacceptable toxicity and six (18.2%) for worsening in their clinical situation and progression. The other five (15.1%) continues with active treatment. Compliance among these patients was 90%.The median of PFS for the 33 patients in the follow-up phase was 209±53 days and the PFS at 1 year was 15%±7%.ConclusionIn more than one-third of our HCC patients who started sorafenib, the drug could be deemed ineffective and harmful. In the patients who survived the initial phase of 45 days, PFS yielded slightly better results than expected from clinical trials. Limitations of the study include lack of data on patient-related outcomes.No conflict of interest
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- 2018
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34. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review
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Kerry Dwan, Carrol Gamble, Jamie Kirkham, Erik Von Elm, Philippa Easterbrook, Reporting Bias Group, Altman, DG., Arnaiz, JA., Bloom, J., Chan, AW., Clarke, M., Cronin, E., Decullier, E., Easterbrook, PJ., Von Elm, E., Ghersi, D., Higgins, JP., Ioannidis, JP., Simes, J., and Sterne, JA.
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Research Validity ,medicine.medical_specialty ,Clinical Research Design ,Science Policy ,Publication Ethics ,lcsh:Medicine ,Odds ,law.invention ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Outcome Assessment, Health Care ,Humans ,Medicine ,Clinical Trials ,030212 general & internal medicine ,lcsh:Science ,Research Integrity ,Randomized Controlled Trials as Topic ,Protocol (science) ,Multidisciplinary ,Research Monitoring ,business.industry ,Statistics ,Publications ,lcsh:R ,Publication bias ,Research Assessment ,3. Good health ,Clinical trial ,Systematic review ,Case-Control Studies ,Family medicine ,Meta-analysis ,Research Reporting Guidelines ,lcsh:Q ,Meta-Analyses ,business ,Publication Bias ,Mathematics ,Publication Practices ,030217 neurology & neurosurgery ,Research Article ,Cohort study - Abstract
BACKGROUND: The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias and outcome reporting bias have been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. METHODOLOGY/PRINCIPAL FINDINGS: In this update, we review and summarise the evidence from cohort studies that have assessed study publication bias or outcome reporting bias in randomised controlled trials. Twenty studies were eligible of which four were newly identified in this update. Only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Fifteen of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40-62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. CONCLUSIONS: This update does not change the conclusions of the review in which 16 studies were included. Direct empirical evidence for the existence of study publication bias and outcome reporting bias is shown. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.
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- 2013
35. Time series of freshwater macroinvertebrate abundances and site characteristics of European streams and rivers.
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Welti EAR, Bowler DE, Sinclair JS, Altermatt F, Álvarez-Cabria M, Amatulli G, Angeler DG, Archambaud G, Arrate Jorrín I, Aspin T, Azpiroz I, Baker NJ, Bañares I, Barquín Ortiz J, Bodin CL, Bonacina L, Bonada N, Bottarin R, Cañedo-Argüelles M, Csabai Z, Datry T, de Eyto E, Dohet A, Domisch S, Dörflinger G, Drohan E, Eikland KA, England J, Eriksen TE, Evtimova V, Feio MJ, Ferréol M, Floury M, Forcellini M, Forio MAE, Fornaroli R, Friberg N, Fruget JF, Garcia Marquez JR, Georgieva G, Goethals P, Graça MAS, House A, Huttunen KL, Jensen TC, Johnson RK, Jones JI, Kiesel J, Larrañaga A, Leitner P, L'Hoste L, Lizée MH, Lorenz AW, Maire A, Manzanos Arnaiz JA, Mckie B, Millán A, Muotka T, Murphy JF, Ozolins D, Paavola R, Paril P, Peñas Silva FJ, Polasek M, Rasmussen J, Rubio M, Sánchez Fernández D, Sandin L, Schäfer RB, Schmidt-Kloiber A, Scotti A, Shen LQ, Skuja A, Stoll S, Straka M, Stubbington R, Timm H, Tyufekchieva VG, Tziortzis I, Uzunov Y, van der Lee GH, Vannevel R, Varadinova E, Várbíró G, Velle G, Verdonschot PFM, Verdonschot RCM, Vidinova Y, Wiberg-Larsen P, and Haase P
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- Animals, Europe, Fresh Water, Population Dynamics, Water Quality, Biodiversity, Ecosystem, Invertebrates, Rivers
- Abstract
Freshwater macroinvertebrates are a diverse group and play key ecological roles, including accelerating nutrient cycling, filtering water, controlling primary producers, and providing food for predators. Their differences in tolerances and short generation times manifest in rapid community responses to change. Macroinvertebrate community composition is an indicator of water quality. In Europe, efforts to improve water quality following environmental legislation, primarily starting in the 1980s, may have driven a recovery of macroinvertebrate communities. Towards understanding temporal and spatial variation of these organisms, we compiled the TREAM dataset (Time seRies of European freshwAter Macroinvertebrates), consisting of macroinvertebrate community time series from 1,816 river and stream sites (mean length of 19.2 years and 14.9 sampling years) of 22 European countries sampled between 1968 and 2020. In total, the data include >93 million sampled individuals of 2,648 taxa from 959 genera and 212 families. These data can be used to test questions ranging from identifying drivers of the population dynamics of specific taxa to assessing the success of legislative and management restoration efforts., (© 2024. The Author(s).)
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- 2024
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36. Vaccination strategies for patients under monoclonal antibody and other biological treatments: an updated comprehensive review based on EMA authorisations to January 2024.
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Rivera-Izquierdo M, Morales-Portillo A, Guerrero-Fernández de Alba I, Fernández-Martínez NF, Schoenenberger-Arnaiz JA, Barranco-Quintana JL, and Valero-Ubierna C
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- Humans, Immunization Schedule, COVID-19 Vaccines immunology, COVID-19 Vaccines administration & dosage, Vaccine Development methods, Biological Therapy methods, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal immunology, Immunocompromised Host, Vaccination methods, COVID-19 prevention & control, COVID-19 immunology
- Abstract
Introduction: Monoclonal antibodies (mAbs) and other biological agents are being increasingly approved in the last years with very different indications. Their highly heterogeneous immunosuppressive effects, mechanisms of action and pharmacokinetics require comprehensive individualized vaccination schedules., Areas Covered: Vaccination for immunocompromised patients. Prevention and treatment with mAbs and other biological therapies., Expert Opinion: Current recommendations on vaccine schedules for patients under mAbs or other biological treatments are based on expert opinions and are not individualized according to each vaccine and treatment. No studies are focusing on the high heterogeneity of these agents, which are exponentially developed and used for many different indications. Recent paradigm changes in vaccine development (boosted by the COVID-19 pandemic) and in the mAbs use for prophylactic purposes (changing 'vaccination' by 'immunization' schedules) has been witnessed in the last years. We aimed at collecting all mAbs used for treatment or prevention, approved as of 1 January 2024, by the EMA. Based on available data on mAbs and vaccines, we propose a comprehensive guide for personalizing vaccination. Recent vaccine developments and current population strategies (e.g. zoster vaccination or prophylactic nirsevimab) are discussed. This review aims to be a practical guideline for professionals working in vaccine consultations for immunosuppressed patients.
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- 2024
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37. Safety and immunogenicity of a recombinant protein RBD fusion heterodimer vaccine against SARS-CoV-2.
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Leal L, Pich J, Ferrer L, Nava J, Martí-Lluch R, Esteban I, Pradenas E, Raïch-Regué D, Prenafeta A, Escobar K, Pastor C, Ribas-Aulinas M, Trinitè B, Muñoz-Basagoiti J, Domenech G, Clotet B, Corominas J, Corpes-Comes A, Garriga C, Barreiro A, Izquierdo-Useros N, Arnaiz JA, Soriano A, Ríos J, Nadal M, Plana M, Blanco J, Prat T, Torroella E, and Ramos R
- Abstract
In response to COVID-19 pandemic, we have launched a vaccine development program against SARS-CoV-2. Here we report the safety, tolerability, and immunogenicity of a recombinant protein RBD fusion heterodimeric vaccine against SARS-CoV-2 (PHH-1V) evaluated in a phase 1-2a dose-escalation, randomized clinical trial conducted in Catalonia, Spain. 30 young healthy adults were enrolled and received two intramuscular doses, 21 days apart of PHH-1V vaccine formulations [10 µg (n = 5), 20 µg (n = 10), 40 µg (n = 10)] or control [BNT162b2 (n = 5)]. Each PHH-1V group had one safety sentinel and the remaining participants were randomly assigned. The primary endpoint was solicited events within 7 days and unsolicited events within 28 days after each vaccination. Secondary endpoints were humoral and cellular immunogenicity against the variants of concern (VOCs) alpha, beta, delta and gamma. All formulations were safe and well tolerated, with tenderness and pain at the site of injection being the most frequently reported solicited events. Throughout the study, all participants reported having at least one mild to moderate unsolicited event. Two unrelated severe adverse events (AE) were reported and fully resolved. No AE of special interest was reported. Fourteen days after the second vaccine dose, all participants had a >4-fold change in total binding antibodies from baseline. PHH-1V induced robust humoral responses with neutralizing activities against all VOCs assessed (geometric mean fold rise at 35 days p < 0.0001). The specific T-cell response assessed by ELISpot was moderate. This initial evaluation has contributed significantly to the further development of PHH-1V, which is now included in the European vaccine portfolio.ClinicalTrials.gov Identifier NCT05007509EudraCT No. 2021-001411-82., (© 2023. Springer Nature Limited.)
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- 2023
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38. Impact of an Antimicrobial Stewardship Strategy on Surgical Hospital Discharge: Improving Antibiotic Prescription in the Transition of Care.
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Jover-Sáenz A, Santos Rodríguez C, Ramos Gil MÁ, Palomera Fernández M, Invencio da Costa LF, Torres-Puig-Gros J, Castellana Perelló D, Montiu González E, Schoenenberger-Arnaiz JA, Bordalba Gómez JR, Galindo Ortego X, and Ramirez-Hidalgo M
- Abstract
Antimicrobial stewardship programs (AMSPs) are essential elements in reducing the unnecessary overprescription of antibiotics. Most of the actions of these programs have focused on actions during acute hospitalization. However, most prescriptions occur after hospital discharge, which represents a necessary and real opportunity for improvement in these programs. We present an AMSP multifaceted strategy implemented in a surgical department which was carried out by a multidisciplinary team to verify its reliability and effectiveness. Over a 1-year post-implementation period, compared to the pre-intervention period, a significant reduction of around 60% in antibiotic exposure occurred, with lower economic cost and greater safety.
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- 2023
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39. Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost-effectiveness and cost-utility analyses.
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Durand-Zaleski I, Ducrocq G, Mimouni M, Frenkiel J, Avendano-Solá C, Gonzalez-Juanatey JR, Ferrari E, Lemesle G, Puymirat E, Berard L, Cachanado M, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, Calvo G, Danchin N, Paco S, Drouet E, Abergel H, Rousseau A, Simon T, and Steg PG
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- Humans, Cost-Benefit Analysis, Quality of Life, Prospective Studies, Erythrocyte Transfusion adverse effects, Erythrocyte Transfusion methods, Anemia etiology, Myocardial Infarction therapy, Myocardial Infarction etiology
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Aims: To estimate the cost-effectiveness and cost-utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia., Methods and Results: Patients (n = 666) with AMI and haemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost-utility ratio.The 30-day incremental cost-effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE-reducing (i.e. dominant). At 1 year, the point estimate of the cost-utility ratio was €191 500 saved per quality-adjusted life year gained; however, the cumulated MACE was outside the pre-specified non-inferiority margin, resulting in a decremental cost-effectiveness ratio with a point estimate of €72 000 saved per additional MACE with the restrictive strategy., Conclusion: In patients with AMI and anaemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving, but clinical non-inferiority on MACE was no longer maintained., Trial Registration: ClinicalTrials.gov Identifier: NCT02648113., One Sentence Summary: The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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40. One-Year Major Cardiovascular Events After Restrictive Versus Liberal Blood Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Trial.
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Gonzalez-Juanatey JR, Lemesle G, Puymirat E, Ducrocq G, Cachanado M, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, Ferrari E, Calvo G, Danchin N, Avendano-Solá C, Rousseau A, Vicaut E, Gonzalez-Ferrero T, Steg PG, and Simon T
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- Acute Disease, Anemia therapy, Cardiovascular Diseases mortality, Cardiovascular Diseases physiopathology, Humans, Myocardial Infarction therapy, Survival Analysis, Time Factors, Anemia complications, Blood Transfusion methods, Cardiovascular Diseases etiology, Myocardial Infarction complications
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- 2022
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41. Oral hydration as a safe prophylactic measure to prevent post-contrast acute kidney injury in oncologic patients with chronic kidney disease (IIIb) referred for contrast-enhanced computed tomography: subanalysis of the oncological group of the NICIR study.
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Sebastià C, Páez-Carpio A, Guillen E, Paño B, Arnaiz JA, De Francisco ALM, Nicolau C, and Oleaga L
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- Contrast Media adverse effects, Humans, Retrospective Studies, Risk Factors, Tomography, X-Ray Computed, Acute Kidney Injury, Renal Insufficiency, Chronic complications
- Abstract
Background: T he objective of this study is to evaluate oral hydration compared to intravenous (i.v.) hydration in the prevention of post-contrast acute kidney injury (PC-AKI) in the oncologic subgroup of patients with stage IIIb chronic kidney disease (CKD) included in the NICIR study referred for elective contrast-enhanced computed tomography (CE-CT)., Material and Methods: We performed a retrospective subanalysis of the oncological subgroup (174/228 patients, 74%) from a continuous prospective database of patients included in the recently published non-inferiority NICIR study. Patients received prophylaxis against PC-AKI with either oral hydration (500 mL of water 2 h before and 2000 mL during the 24 h after CE-CT) or i.v. hydration (sodium bicarbonate (166 mmol/L) 3 mL/kg/h starting 1 h before and 1 mL/kg/h during the first hour after CE-CT). The primary outcome was to compare the proportion of PC-AKI in the first 48 to 72 h after CE-CT in the two hydration groups. Secondary outcomes were to compare persistent PC-AKI, the need for haemodialysis, and the occurrence of adverse events related to prophylaxis in each group., Results: Of 174 patients included in the subanalysis, 82 received oral hydration and 92 received i.v. hydration. There were no significant differences in clinical characteristics or risk factors between the two study arms. Overall the PC-AKI rate was 4.6% (8/174 patients), being 3.7% in the oral hydration arm (3/82 patients) and 5.4% (5/92 patients) in the i.v. hydration arm. The persistent PC-AKI rate was 1.2% (1/82 patients) in the oral hydration arm and 3.3% (3/92 patients) in the i.v. hydration arm. No patient required dialysis during the first month after CE-CT or had adverse effects related to the hydration regime., Conclusion: In oncological patients with stage IIIb CKD referred for elective CE-CT, the rate of PC-AKI in those receiving oral hydration did not significantly differ from that of patients receiving i.v. hydration., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2022
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42. A patient with ulcerative colitis treated with a combination of vedolizumab and tofacitinib.
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Taberner Bonastre P, Torres Vicente G, Cano-Marron M, Sese Abizanda E, Volta Pardo TD, and Schoenenberger-Arnaiz JA
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- Antibodies, Monoclonal, Humanized therapeutic use, Humans, Male, Middle Aged, Piperidines therapeutic use, Pyrimidines, Colitis, Ulcerative diagnosis, Colitis, Ulcerative drug therapy
- Abstract
Ulcerative colitis (UC) is an inflammatory bowel disease of autoimmune origin with an estimated prevalence in Spain of 0.39%. Current treatments for UC do not achieve high long-term efficacy. Treatment recommendations in moderate and severe disease involve drugs, but when these options fail, the alternatives are scarce, and surgery is intended to be reserved for the last option. We present the case of a 48-year-old male patient with UC for 23 years, who had failed several lines of treatment. The patient started combined therapy with tofacitinib and vedolizumab. These drugs have different mechanisms of action, achieving an immune response and reducing gastrointestinal inflammation. The patient's disease symptoms improved 11 months after starting this treatment, and he is now entirely asymptomatic. Analytical parameters related to the disease have also shown improvement, and the patient has so far avoided the need for surgical intervention., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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43. The usefulness of Olanzapine plasma concentrations in monitoring treatment efficacy and metabolic disturbances in first-episode psychosis.
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Arnaiz JA, Rodrigues-Silva C, Mezquida G, Amoretti S, Cuesta MJ, Fraguas D, Lobo A, González-Pinto A, Díaz-Caneja MC, Corripio I, Vieta E, Baeza I, Mané A, García-Rizo C, Bioque M, Saiz J, Bernardo M, and Mas S
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- Adult, Antipsychotic Agents therapeutic use, Blood Glucose analysis, Blood Pressure drug effects, Female, Humans, Male, Middle Aged, Olanzapine therapeutic use, Psychotic Disorders blood, Psychotic Disorders psychology, Smoking blood, Treatment Outcome, Weight Gain drug effects, Antipsychotic Agents blood, Drug Monitoring methods, Olanzapine blood, Psychotic Disorders drug therapy
- Abstract
Introduction: The role of Olanzapine therapeutic drug monitoring is controversial. The present study explores the associations of Olanzapine plasma concentrations with clinical response and metabolic side effects in first episode psychosis (FEP) after 2 months of treatment., Methods: Forty-seven patients were included. Improvement in clinical symptomatology was assessed using the PANSS. Metabolic assessment included weight, blood pressure, waist circumference, blood glucose, total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides., Results: The Olanzapine plasma concentrations after 2 months of treatment were positively correlated with weight gain (r = 0.49, p = 0.003), and a concentration > 23.28 ng/mL was identified as a positive predictor of weight gain (≥ 7%). The Olanzapine concentration to dose (C/D) ratio was positively correlated with the percentage of improvement in the total PANSS (r = 0.46, p = 0.004), and a C/D ratio > 2.12 was identified as a positive predictor of a good response (percentage of improvement > 30%) after 2 months of treatment. We also identified several factors that could alter Olanzapine pharmacokinetics: gender (p = 0.03), diagnosis (p = 0.05), smoking habit (p = 0.05), and co-medications such as valproic acid (p = 0.05) and anxiolytics (p = 0.01)., Discussion: In conclusion, our results suggest that therapeutic drug monitoring of Olanzapine could be helpful to evaluate therapeutic efficacy and metabolic dysfunction in FEP patients treated with Olanzapine.
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- 2021
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44. Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial.
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Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, Lemesle G, Cachanado M, Durand-Zaleski I, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, Ferrari E, Calvo G, Danchin N, Avendaño-Solá C, Frenkiel J, Rousseau A, Vicaut E, Simon T, and Steg PG
- Subjects
- Aged, Aged, 80 and over, Anemia complications, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, Female, Hemoglobins analysis, Humans, Male, Myocardial Infarction blood, Myocardial Infarction complications, Anemia therapy, Blood Transfusion, Myocardial Infarction therapy
- Abstract
Importance: The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear., Objective: To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy., Design, Setting, and Participants: Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL. Enrollment could be considered at any time during the index admission for myocardial infarction. The first participant was enrolled in March 2016 and the last was enrolled in September 2019. The final 30-day follow-up was accrued in November 2019., Interventions: Patients were randomly assigned to undergo a restrictive (transfusion triggered by hemoglobin ≤8; n = 342) or a liberal (transfusion triggered by hemoglobin ≤10 g/dL; n = 324) transfusion strategy., Main Outcomes and Measures: The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% CI for the relative risk of the primary outcome be less than 1.25. The secondary outcomes included the individual components of the primary outcome., Results: Among 668 patients who were randomized, 666 patients (median [interquartile range] age, 77 [69-84] years; 281 [42.2%] women) completed the 30-day follow-up, including 342 in the restrictive transfusion group (122 [35.7%] received transfusion; 342 total units of packed red blood cells transfused) and 324 in the liberal transfusion group (323 [99.7%] received transfusion; 758 total units transfused). At 30 days, MACE occurred in 36 patients (11.0% [95% CI, 7.5%-14.6%]) in the restrictive group and in 45 patients (14.0% [95% CI, 10.0%-17.9%]) in the liberal group (difference, -3.0% [95% CI, -8.4% to 2.4%]). The relative risk of the primary outcome was 0.79 (1-sided 97.5% CI, 0.00-1.19), meeting the prespecified noninferiority criterion. In the restrictive vs liberal group, all-cause death occurred in 5.6% vs 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups., Conclusions and Relevance: Among patients with acute myocardial infarction and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. However, the CI included what may be a clinically important harm., Trial Registration: ClinicalTrials.gov Identifier: NCT02648113.
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- 2021
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45. Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the REALITY trial.
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Ducrocq G, Calvo G, González-Juanatey JR, Durand-Zaleski I, Avendano-Sola C, Puymirat E, Lemesle G, Arnaiz JA, Martínez-Sellés M, Rousseau A, Cachanado M, Vicaut E, Silvain J, Karam C, Danchin N, Simon T, and Steg PG
- Subjects
- Blood Transfusion, Erythrocyte Transfusion, Hemoglobins, Humans, Anemia diagnosis, Anemia therapy, Myocardial Infarction complications, Myocardial Infarction therapy
- Abstract
Background: Anemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear., Hypothesis: We hypothesized that a "restrictive" transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a "liberal" transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly., Methods: REALITY is an international, randomized, multicenter, open-label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year., Results: The trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost-effectiveness of the restrictive strategy at a threshold of €50 000 per quality-adjusted life year., Conclusions: REALITY will provide important guidance on the management of patients with AMI and anemia., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)
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- 2021
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46. The positive allosteric modulator of the mGlu2 receptor JNJ-46356479 partially improves neuropathological deficits and schizophrenia-like behaviors in a postnatal ketamine mice model.
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Martínez-Pinteño A, García-Cerro S, Mas S, Torres T, Boloc D, Rodríguez N, Lafuente A, Gassó P, Arnaiz JA, and Parellada E
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- Animals, Disease Models, Animal, Mice, Parvalbumins, Antipsychotic Agents pharmacology, Ketamine, Schizophrenia chemically induced, Schizophrenia drug therapy
- Abstract
Current antipsychotics have limited efficacy in controlling cognitive and negative symptoms of schizophrenia (SZ). Glutamatergic dysregulation has been implicated in the pathophysiology of SZ, based on the capacity of N-methyl-D-aspartate receptor (NMDAR) antagonists such as ketamine (KET) to induce SZ-like behaviors. This could be related to their putative neuropathological effect on gamma-aminobutyric (GABAergic) interneurons expressing parvalbumin (PV), which would lead to a hyperglutamatergic condition. Metabotropic glutamate receptor 2 (mGluR2) negatively modulates glutamate release and has been considered a potential clinical target for novel antipsychotics drugs. Our aim was to evaluate the efficacy of JNJ-46356479 (JNJ), a positive allosteric modulator (PAM) of the mGluR2, in reversing neuropathological and behavioral deficits induced in a postnatal KET mice model of SZ. These animals presented impaired spontaneous alternation in the Y-maze test, suggesting deficits in spatial working memory, and a decrease in social motivation and memory, assessed in both the Three-Chamber and the Five Trial Social Memory tests. Interestingly, JNJ treatment of adult mice partially reversed these deficits. Mice treated with KET also showed a reduction in PV+ in the mPFC and dentate gyrus together with an increase in c-Fos expression in this hippocampal area. Compared to the control group, mice treated with KET + JNJ showed a similar PV density and c-Fos activity pattern. Our results suggest that pharmacological treatment with a PAM of the mGluR2 such as JNJ could help improve cognitive and negative symptoms related to SZ., (Copyright © 2020 Elsevier Ltd. All rights reserved.)
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- 2020
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47. Identifying key transcription factors for pharmacogenetic studies of antipsychotics induced extrapyramidal symptoms.
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Boloc D, Rodríguez N, Torres T, García-Cerro S, Parellada M, Saiz-Ruiz J, Cuesta MJ, Bernardo M, Gassó P, Lafuente A, Mas S, and Arnaiz JA
- Subjects
- Animals, Basal Ganglia Diseases metabolism, Computational Biology methods, Follow-Up Studies, Humans, Longitudinal Studies, Mice, Polymorphism, Single Nucleotide drug effects, Polymorphism, Single Nucleotide physiology, Prospective Studies, Protein Binding drug effects, Protein Binding physiology, Transcription Factors biosynthesis, Antipsychotic Agents adverse effects, Basal Ganglia Diseases chemically induced, Basal Ganglia Diseases genetics, Pharmacogenetics methods, Pharmacogenomic Testing methods, Transcription Factors genetics
- Abstract
Introduction: We explore the transcription factors involved in the molecular mechanism of antipsychotic (AP)-induced acute extrapyramidalsymptoms (EPS) in order to identify new candidate genes for pharmacogenetic studies., Methods: Protein-protein interaction (PPI) networks previously created from three pharmacogenomic models (in vitro, animal, and peripheral blood inhumans) were used to, by means of several bioinformatic tools; identify key transcription factors (TFs) that regulate each network. Once the TFs wereidentified, SNPs disrupting the binding sites (TFBS) of these TFs in the genes of each network were selected for genotyping. Finally, SNP-basedassociations with EPS were analyzed in a sample of 356 psychiatric patients receiving AP., Results: Our analysis identified 33 TFs expressed in the striatum, and 125 SNPs disrupting TFBS in 50 genes of our initial networks. Two SNPs (rs938112,rs2987902) in two genes (LSMAP and ABL1) were significantly associated with AP induced EPS (p < 0.001). These SNPs disrupt TFBS regulated byPOU2F1., Conclusion: Our results highlight the possible role of the disruption of TFBS by SNPs in the pharmacological response to AP.
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- 2020
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48. Response to fluoxetine in children and adolescents: a weighted gene co-expression network analysis of peripheral blood.
- Author
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Torres T, Boloc D, Rodríguez N, Blázquez A, Plana MT, Varela E, Gassó P, Martinez-Pinteño A, Lázaro L, Arnaiz JA, and Mas S
- Abstract
The inconclusive and non-replicated results of pharmacogenetic studies of antidepressant response could be related to the lack of acknowledgement of its mechanism of action. In this scenario, gene expression studies provide and interesting framework to reveal new candidate genes for pharmacogenetic studies or peripheral biomarkers of fluoxetine response. We propose a system biology approach to analyse changes in gene expression induced by eight weeks of treatment with fluoxetine in peripheral blood. 21 naïve child and adolescents participated in the present study. Our analysis include the identification of gene co-expression modules, using Weighted Gene Co-expression Network Analysis (WGCNA), followed by protein-protein interaction (PPi) network construction coupled with functional annotation. Our results revealed two modules of co-expression genes related to fluoxetine treatment. The constructed networks from these modules were enriched for biological processes related to cellular and metabolic processes, cell communication, immune system processes, cell death, response to stimulus and neurogenesis. Some of these processes, such as immune system, replicated previous findings in the literature, whereas, neurogenesis, a mechanism proposed to be involved in fluoxetine response, had been identified for first time using peripheral tissues. In conclusion, our study identifies several biological processes in relation to fluoxetine treatment in peripheral blood, offer new candidate genes for pharmacogenetic studies and valuable markers for peripheral moderator biomarkers discovery., Competing Interests: None., (AJTR Copyright © 2020.)
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- 2020
49. Association study of candidate genes with obesity and metabolic traits in antipsychotic-treated patients with first-episode psychosis over a 2-year period.
- Author
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Gassó P, Arnaiz JA, Mas S, Lafuente A, Bioque M, Cuesta MJ, Díaz-Caneja CM, García C, Lobo A, González-Pinto A, Parellada M, Corripio I, Vieta E, Castro-Fornieles J, Mané A, Rodríguez N, Boloc D, Saiz-Ruiz J, and Bernardo M
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- Adolescent, Adult, Antipsychotic Agents adverse effects, Female, Follow-Up Studies, Genetic Predisposition to Disease, Genotype, Humans, Male, Metabolic Diseases genetics, Obesity genetics, Phenotype, Polymorphism, Single Nucleotide, Time Factors, Weight Gain drug effects, Weight Gain genetics, Young Adult, Antipsychotic Agents administration & dosage, Metabolic Diseases epidemiology, Obesity epidemiology, Psychotic Disorders drug therapy
- Abstract
Aims: Patients with a first episode of psychosis (FEP) often display different metabolic disturbances even independently of drug therapy. However, antipsychotic (AP) treatment, especially with second-generation APs, is strongly linked to weight gain, which increases patients' risk of developing obesity and other metabolic diseases. There is an important genetic risk component that can contribute to the appearance of these disturbances. The aim of the present study was to evaluate the effect of polymorphisms in selected candidate genes on obesity and other anthropometric and metabolic traits in 320 AP-treated FEP patients over the course of a 2-year follow-up., Methods: These patients were recruited in the multicentre PEPs study (Phenotype-genotype and environmental interaction; Application of a predictive model in first psychotic episodes). A total of 127 validated single nucleotide polymorphisms (SNPs) in 18 candidate genes were included in the genetic analysis., Results: After Bonferroni correction, SNPs in ADRA2A, FTO, CNR1, DRD2, DRD3, LEPR and BDNF were associated with obesity, abdominal circumference, triglycerides, HDL cholesterol, and/or percentage of glycated haemoglobin., Conclusions: Although our results should be interpreted as exploratory, they support previous evidence of the impact of these candidate genes on obesity and metabolic status. Further research is required to gain a better knowledge of the genetic variants that can be considered relevant metabolic risk factors. The ability to identify FEP patients at higher risk for these metabolic disturbances would enable clinicians to better select and control their AP treatment.
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- 2020
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50. Usefulness of therapeutic drug monitoring of piperacillin and meropenem in routine clinical practice: a prospective cohort study in critically ill patients.
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Schoenenberger-Arnaiz JA, Ahmad-Diaz F, Miralbes-Torner M, Aragones-Eroles A, Cano-Marron M, and Palomar-Martinez M
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- Aged, Anti-Bacterial Agents administration & dosage, Cohort Studies, Female, Humans, Infusions, Intravenous, Male, Meropenem administration & dosage, Middle Aged, Piperacillin, Tazobactam Drug Combination administration & dosage, Prospective Studies, Sepsis drug therapy, Anti-Bacterial Agents blood, Critical Illness therapy, Drug Monitoring methods, Meropenem blood, Piperacillin, Tazobactam Drug Combination blood, Sepsis blood
- Abstract
Background: Beta-lactam anti-infective levels after standard dosing have been shown to be subtherapeutic when renal clearance is augmented., Objective: To determine if piperacillin and meropenem are found to be in their therapeutic range in infected critically ill patients when administered by continuous intravenous infusion (CII) assisted by a therapeutic drug monitoring (TDM) report issued by the pharmacy service., Methods: This prospective non-controlled intervention study evaluated septic patients in an intensive care unit. Patients received a loading dose of meropenem or piperacillin-tazobactam and the antibiotics were afterwards administered by CII. Blood concentrations were determined by high-performance liquid chromatography assays. The adequacy of β-lactam therapy in the cohort subjected to intervention was assessed by determining whether plasma levels during CII were >4 times the informed minimum inhibitory concentration during the first 96 hours of treatment., Results: A total of 124 patients were subject to TDM during antibiotic treatment but, for the analysis of the fulfilment of pharmacodynamic requirements, data from 31/124 (25%) were excluded. Of the whole cohort of treatment courses, 57/93 (61.3%) reached the target level. Plasma levels were adequate in 41/70 (58.6%) and 16/23 (69.6%) of the patients treated with piperacillin-tazobactam and meropenem, respectively. Globally, recommendations based on TDM results were followed in 35/93 (37.6%) of the treatment courses., Conclusions: The results of the study show that, in critically ill patients with sepsis, there is a significant proportion of treatment courses where target levels are not reached even if the antibiotics are administered by CII and TDM support is provided by the pharmacy service. This TDM support should be offered on a real-time basis to be really useful., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2020. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2020
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