Estudio observacional del uso de etanercept biosimilar en el tratamiento de enfermedades reumáticas / Etanercept in rheumatic diseases: observational study

Objetivos: 1.- Conocer la respuesta a etanercept biosimilar (E-BS) en pacientes naive y en pacientes a los que se realizó cambio desde el de referencia (E-R), diagnosticados de enfermedades reumáticas. 2.- Evaluar el impacto económico de estas actuaciones.Métodos: Estudio observacional retrospectivo de 110 pacientes en tratamiento con etanercept (referencia y/o biosimilar). Se analizaron dos grupos de pacientes: 62 pacientes que iniciaron tratamiento con E-BS y 48 pacientes a los que se les realizó cambio desde E-R (switch), y se compararon con grupos control. Variables analizadas: edad, sexo, diagnóstico, tratamiento, unidades dispensadas, modificaciones del tratamiento, motivo de suspensión o cambio, fecha de suspensión y tiempo de seguimiento. Se comparó el coste de la utilización del biosimilar y del que hubiera supuesto el de referencia.Resultados: Las tasas de retención observadas fueron: 65% en los naive (p=0,002) y 90% en los switch. En pacientes naive, el principal motivo de cambio fue respuesta parcial o insuficiente (90%) y en switch posible efecto nocebo (60%). No se observaron reacciones adversas. Al comparar estos grupos con poblaciones control, la principal diferencia fue la proporción de pacientes en los que se mantuvo tratamiento con E-BS frente a E-R, en pacientes naive (65% vs 34%; p=0,003) y switch (90% vs 27%; p<0,0001). La utilización de E-BS supuso un ahorro de 653.668 €.Conclusiones: La utilización de E-BS no fue diferente del E-R en cuanto a resultados clínicos y, desde el punto de vista económico, supone un ahorro sustancial que se debe considerar como medida que ayude a la sostenibilidad del sistema. (AU)

Objetive: 1.- To know the response to biosimilar etanercept (E-BS) in naive patients and in patients who change from the reference (E-R), diagnosed with rheumatic diseases. 2.- To evaluate the economic impact of these actions.Methods: Retrospective observational study of 110 patients in treatment with etanercept (reference and/or biosimilar). Two groups of patients were analyzed: 62 patients who started with E-BS and 48 patients who change from E-R (switch), and they were compared with control groups. Variables analyzed: age, sex, diagnosis, treatment, units dispensed, treatment modifications, reason for suspension or change, date of suspension and follow-up time. The cost of using the biosimilar was compared with that of the reference one.Results: The retention rates observed were: 65% in the naive (p=0.002) and 90% in switch. In naive patients, the main reason for change was partial or insufficient response (90%) and a possible nocebo effect in switch (60%). No adverse reactions were observed. When comparing these groups with control populations, the main difference was the proportion of patients in whom treatment with E-BS was maintained versus ER, in naive patients (65% vs 34%; p=0.003) and in switch (90% vs 27%; p<0.0001). The use of E-BS meant a saving of € 653,668.Conclusions: The use of E-BS was not different from the E-R in terms of clinical results and, from the economic point of view, represents a substantial saving that should be considered as a measure that helps the sustainability of the system. (AU)

Impacto económico de las nuevas terapias orales en esclerosis múltiple / Economic impact of the new oral treatments for multiple sclerosis

INTRODUCCIÓN: La esclerosis múltiple (EM) es una enfermedad crónica del sistema nervioso central que se caracteriza por la existencia de inflamación, desmielinización, gliosis y daño axonal. La introducción de dimetilfumarato y teriflunomida ha supuesto un aumento de las alternativas terapéuticas en la primera línea de tratamiento de la EM. El objetivo de este estudio fue evaluar el impacto económico de la incorporación de estas nuevas terapias orales en la Unidad de Referencia (CSUR) del Hospital Universitario Puerta de Hierro Majadahonda. MATERIAL Y MÉTODOS: Se realizó un estudio observacional retrospectivo en la población de pacientes diagnosticados de EM, en tratamiento con fármacos modificadores de la enfermedad durante el año 2015, y su seguimiento se prolongó hasta obtener un seguimiento medio superior a un año de tratamiento. Los datos se recogieron de la historia clínica electrónica y del programa de dispensación de medicamentos a pacientes externos y ambulantes del Servicio de Farmacia. RESULTADOS: Evaluando el coste del cambio del tratamiento en 125 pacientes desde otros fármacos a dimetilfumarato o teriflunomida y comparando con el coste que habría supuesto el mantenimiento de los tratamientos previos, el ahorro total durante el periodo de observación fue de 169.107,31 (Euro). CONCLUSIONES: Dimetilfumarato y teriflunomida, además de aportar nuevas alternativas terapéuticas, no solo no han supuesto un incremento sino, por el contrario, una disminución en los costes del tratamiento de la EM en nuestro hospital

INTRODUCTION: Multiple sclerosis (MS) is a chronic disease affecting the central nervous system and is characterised by inflammation, demyelination, gliosis, and axonal damage. The introduction of dimethyl fumarate and teriflunomide has led to an increase in the number of alternative first-line therapies for MS. The objective of this study was to evaluate the economic impact of the incorporation of new oral therapies at the reference unit (CSUR) at Hospital Universitario Puerta de Hierro Majadahonda. MATERIALS AND METHODS: We performed a retrospective observational study including patients diagnosed with MS, who underwent treatment with disease-modifying drugs in 2015 and were followed up for a minimum mean time of one year. Data were collected from patients' electronic clinical histories and the pharmacy service's programme for dispensing drugs to outpatients. RESULTS: Evaluating the cost of changing 125 patients' treatment from other drugs to dimethyl fumarate and teriflunomide, and comparing this with the cost that would have resulted from maintaining their previous treatment, demonstrated a total saving of (Euro)169,107.31 over the study period. CONCLUSIONS: In addition to contributing new therapeutic alternatives, dimethyl fumarate and teriflunomide produced an economic saving in MS treatment at our hospital

Economic impact of the new oral treatments for multiple sclerosis. / Impacto económico de las nuevas terapias orales en esclerosis múltiple.

INTRODUCTION: Multiple sclerosis (MS) is a chronic disease affecting the central nervous system and is characterised by inflammation, demyelination, gliosis, and axonal damage. The introduction of dimethyl fumarate and teriflunomide has led to an increase in the number of alternative first-line therapies for MS. The objective of this study was to evaluate the economic impact of the incorporation of new oral therapies at the reference unit (CSUR) at Hospital Universitario Puerta de Hierro Majadahonda. MATERIALS AND METHODS: We performed a retrospective observational study including patients diagnosed with MS, who underwent treatment with disease-modifying drugs in 2015 and were followed up for a minimum mean time of one year. Data were collected from patients' electronic clinical histories and the pharmacy service's programme for dispensing drugs to outpatients. RESULTS: Evaluating the cost of changing 125 patients' treatment from other drugs to dimethyl fumarate and teriflunomide, and comparing this with the cost that would have resulted from maintaining their previous treatment, demonstrated a total saving of €169,107.31 over the study period. CONCLUSIONS: In addition to contributing new therapeutic alternatives, dimethyl fumarate and teriflunomide produced an economic saving in MS treatment at our hospital.

Supplementation of University of Wisconsin solution with Nitroglycerin and Nicorandil in long-term myocardial preservation: effects on the oxidative state, endothelial function and morphology.

The purpose of this study was to assess the effects of the addition of Nitroglycerin or Nicorandil to University of Wisconsin solution in long-term myocardial preservation. In a model of heterotopic heart transplantation in pigs, the donor heart was preserved for 24 hours by means of continuous perfusion in this solution, in the presence or absence of these drugs. During this period, the oxygenation and pH of the solution were measured, as were lactate concentrations and enzyme release. At regular intervals following reperfusion we measured the concentrations of enzymes, antioxidants, glutathione peroxidase, glutathione reductase, malondialdehyde, endothelin and nitrite, and, two hours later, samples of both ventricles were taken for a morphological study. In the treated groups there was a higher lactate production during preservation and, during reperfusion, the signs of contracture and the elevation of enzyme levels were more marked than in the untreated groups. In contrast, the glutathione reductase concentrations did not decrease during the first phase of reperfusion and were directly correlated with those of antioxidants, endothelin levels increased less than in the untreated groups and, in the case of nitroglycerin, the nitrite concentration was significantly greater than in the remaining groups. We conclude that nitroglycerin and nicorandil improved the oxidative state and endothelial function and did not produce substantial morphological changes, but increased cell necrosis and contracture, possibly due to the duration of ischemia.

Heart transplantation: influence of the surgical technique on sinus function.

This study analyzes the influence of the surgical technique on the development of sinus dysfunction. Cycle length, corrected sinus node recovery time, and sinoatrial conduction time were determined in 4 groups of dogs under the following conditions: group 1, controls; group 2, subjected to heterotopic heart transplantation with conservation of atrial anatomy; group 3, subjected to orthotopic heart transplantation by using a standard technique; and group 4, treated as in group 3, but with an ischemic time of 24 hours. The cycle length was prolonged in all the treated groups when compared with the controls (P < .01), an effect attributed to the disconnection of the autonomic nervous system during the transplantation procedure. The corrected sinus node recovery time and sinoatrial conduction time were significantly longer in all the animals in groups 3 and 4 when compared with those of groups 1 and 2 (P < .01); however, there were no significant differences between groups 3 and 4 or between groups 1 and 2. These results suggest that the atrial anatomy play a more relevant role than the ischemic time in the origin of sinus dysfunction occurring after orthotopic heart transplantation.

[Comparative study of the protective role of the vaccine against Haemophilus influenzae type b and partial splenectomy in an experimental model]. / Estudio comparativo del papel protector de la vacuna frente a Haemophilus influenzae tipo b y de la esplenectomía parcial en un modelo experimental.

BACKGROUND: Although the vaccine against Haemophilus influenzae type b has demonstrated its efficacy in children, this bacteria continues to be a cause or overwhelming sepsis in splenetomized patients. METHODS: To compare the degree of protection provided by partial splenectomy and the conjugated diptheria toxoid vaccine against H. influenzae type b, the bacteremia generated 24, 48 and 96 hours after intravenous inoculation with this bacteria at concentrations of 5 x 10(14), 5 x 10(13) and 5 x 10(12) colony-forming units was assessed in rats subjected to total splenectomy, with and without previous vaccination, to partial splenectomy or to sham operation. RESULTS: With respect to both the proportion of positive blood cultures and the concentration of H. influenzae in the blood stream, the sham-operated control rats and those vaccinated prior to splenectomy presented similar behaviors; the widest differences with respect to the latter two groups were found in the nonvaccinated total splenectomy rats, and the results with the partial splenectomy group fell between these two extremes. CONCLUSIONS: The protection of H. influenzae type b vaccine against infection is equivalent to that provided by the intact spleen for inoculum concentrations of 5 x 10(13) colony-forming units and less. Thus, the possibility of its systematic use in asplenic patients should be considered. The protection provided by the remnant spleen following 50% splenectomy is intermediate between those observed with eusplenia and with asplenia. These results suggest that when partial splenectomy is to be performed in normal spleen, the attempt should be made to conserve as much of the organ as possible.

Thrombectomy: surgical treatment of the thrombosed Björk-Shiley prosthesis. Report of seven cases and review of the literature.

Among 1,000 patients with 1,225 Björk-Shiley prostheses, we have detected 12 cases (0.98%) of late thrombosis of the Prosthesis, seven of which were successfully managed by thrombectomy. A review of other authors' experience with this procedure shows no deaths directly attributable to thrombectomy, although two patients had cerebral embolization during the procedure. For prevention of this complication, we propose that both the aorta and the left atrium be explored during thrombectomy of either the mitral or the aortic prosthesis so as to achieve complete exposure of the left ventricular outflow tract and complete removal of any thrombus located in the ventricle. We consider this the procedure of tract and complete removal of any thrombus located in the ventricle. We consider this the procedure of choice in thrombosis of the Björk-Shiley prosthesis. Replacement of the prosthesis would then be restricted to cases of prosthesis damage or those in which adequate anticoagulation cannot be maintained.