Stability of tedizolid phosphate-sodium rifampicin and tedizolid phosphate-meropenem admixtures in intravenous infusion bags stored at different temperatures.

This is a report on the chemical stability and physical compatibility of intravenous tedizolid phosphate 0.8 mg/mL-sodium rifampicin 2.4 mg/mL and tedizolid phosphate 0.8 mg/mL-meropenem 4 mg/mL combinations in polypropylene 0.9% sodium chloride infusion bags stored at different storage conditions. Triplicate solutions of both admixtures were prepared in 0.9% sodium chloride polypropylene infusion bags and stored under light protection at room temperature (25±2 °C), refrigeration (2-8 °C) or freezing (-15 - -25 °C) conditions. The study was performed using a validated and stability-indicating liquid chromatography (LC) method. For both admixtures and for all storage conditions, at least 90% of the initial drug concentration of tedizolid phosphate remained unchanged throughout the entire study period. Stability of sodium rifampicin at 25±2 °C was determined to be seven hours and six days when it was stored at 2-8 °C. Under the same storage conditions, meropenem was stable for 12 h or 6 days, respectively. Under freezing conditions, sodium rifampicin was stable throughout all 28 days, while stability of meropenem was only 8 days. Solutions of 0.8 mg/mL tedizolid phosphate admixtured with 2.4 mg/mL rifampicin or 4 mg/mL meropenem, in polypropylene 0.9% sodium chloride infusion bags, are stable for at least 7 or 12 hours, respectively, when stored at 25±2 °C. When stored at 2-8 °C, stability was increased to 6 days for both admixtures.

Neurotoxicidad asociada a oxaliplatino en la práctica clínica asistencial / Oxaliplatin-associated neurotoxicity in clinical practice

Objetivos: Determinar la presencia de neurotoxicidad asociada a oxaliplatino en la práctica clínica asistencial, la gravedad de la misma y el manejo clínico relacionado con este efecto adverso. Método Estudio observacional retrospectivo que incluyó pacientes diagnosticados de cáncer colorrectal y que iniciaron un esquema de quimioterapia basada en oxaliplatino durante el año 2008 en un hospital de segundo nivel. Los datos se obtuvieron del programa de prescripción de Onco-Hematología propio del hospital y de las historias clínicas informatizadas. Se recogieron variables relacionadas con las características clínicas de los pacientes, con el tratamiento antineoplásico, con la neurotoxicidad asociada a oxaliplatino, así como con su manejo clínico. Resultados Se incluyó un total de 64 pacientes. La presencia de neurotoxicidad se situó en un 65,6%, presentándose mayoritariamente de forma leve o moderada. Alrededor de una tercera parte de los pacientes que presentaron este efecto adverso requirió un cambio en la prescripción de oxaliplatino. Se determinó una relación estadísticamente significativa (p=0,0004) entre dosis acumuladas de oxaliplatino y presencia de toxicidad neurológica. Conclusiones La presencia de neurotoxicidad asociada a oxaliplatino y su distribución en función de su gravedad, es similar a la descrita en literatura médica. El número de pacientes que requiere un cambio en la prescripción de oxaliplatino podría justificar la necesidad de diseñar estudios que valoren las consecuencias clínicas asociadas a estas modificaciones. Consideramos que es necesario el desarrollo de estrategias neuroprotectoras efectivas que garanticen la seguridad y calidad de vida de estos pacientes (AU)

Objectives: To evaluate the presence and severity of oxaliplatin-associated neurotoxicity inclinical practice and the clinical management of this adverse side effect. Method: Observational retrospective study including patients diagnosed with colorectal cancer that started an oxaliplatin-based chemotherapy regimen during 2008 at a secondary hospital. Data were obtained from an onco-haematological prescription programme at the hospital and from digital clinical histories. We compiled variables related to the clinical characteristics of the patients, antineoplastic treatment, neurotoxicity associated with oxaliplatin, and clinical management of this issue. Results: Our study included a total of 64 patients. Neurotoxicity was recorded in 65.6% of cases, usually in mild or moderate forms. In approximately one third of patients who developed this adverse effect, the oxaliplatin prescription had to be modified. We observed a statistically significant relationship between cumulative oxaliplatin doses and the presence of neurological toxicity (P=.0004).Conclusions: The presence of oxaliplatin-associated neurotoxicity and its distribution based onits severity was similar to rates published in the literature. The number of patients requiring a change in the oxaliplatin prescription could justify the need for studies that assess the clinical consequences of these modifications. We believe that effective strategies for neurological protection need to be developed in order to guarantee the safety and quality of life in these patients (AU)

[Oxaliplatin-associated neurotoxicity in clinical practice]. / Neurotoxicidad asociada a oxaliplatino en la práctica clínica asistencial.

OBJECTIVES: To evaluate the presence and severity of oxaliplatin-associated neurotoxicity in clinical practice and the clinical management of this adverse side effect. METHOD: Observational retrospective study including patients diagnosed with colorectal cancer that started an oxaliplatin-based chemotherapy regimen during 2008 at a secondary hospital. Data were obtained from an onco-haematological prescription programme at the hospital and from digital clinical histories. We compiled variables related to the clinical characteristics of the patients, antineoplastic treatment, neurotoxicity associated with oxaliplatin, and clinical management of this issue. RESULTS: Our study included a total of 64 patients. Neurotoxicity was recorded in 65.6% of cases, usually in mild or moderate forms. In approximately one third of patients who developed this adverse effect, the oxaliplatin prescription had to be modified. We observed a statistically significant relationship between cumulative oxaliplatin doses and the presence of neurological toxicity (P=.0004). CONCLUSIONS: The presence of oxaliplatin-associated neurotoxicity and its distribution based on its severity was similar to rates published in the literature. The number of patients requiring a change in the oxaliplatin prescription could justify the need for studies that assess the clinical consequences of these modifications. We believe that effective strategies for neurological protection need to be developed in order to guarantee the safety and quality of life in these patients.

Monitorización de la concentración libre de ácido valproico en un paciente posquirúrgico septicémico / Monitoring free valproic acid concentrations in a post-surgical patient with sepsis

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[Pharmacoeconomic assessment of two tocolysis protocols for the inhibition of premature delivery]. / Evaluación farmacoeconómica de dos protocolos de tocolisis para la inhibición del parto prematuro.

OBJECTIVE: Pharmacoeconomic assessment of two tocolysis protocols alternatively using atosiban or ritodrine as first-choice tocolytic agent able to delay birth for 48 hours in the acute management of premature birth risk in gravid women. METHODS: The modeling technique used for the selection of the most efficient protocol was the decision analysis. A search for controlled clinical trials comparing the effectiveness and/or safety of atosiban versus ritodrine was performed in Medline and the Cochrane Library. Only differential costs were considered for cost analysis. RESULTS: Cost-effectiveness obtained with the protocol including ritodrine as first-choice drug was Euros 194/effectiveness unit, and Euros 632/effectiveness unit when atosiban is used. The sensitivity analysis shows sensitivity only for an incidence of acute lung edema greater than 8% or a cost of at least Euros 50,000. CONCLUSION: A tocolysis protocol using ritodrine as first-choice agent and atosiban as rescue drug is the most efficient option based on available evidence. In pregnant women where the likelihood of developing acute pulmonary edema is high, or when therapy cost is high, atosiban may be an appropriate alternative option.

Evaluación farmacoeconómica de dos protocolos de tocolisis para la inhibición del parto prematuro / Pharmacoeconomic assessment of two tocolysis protocols for the inhibition of premature delivery

Objetivo: Evaluación farmacoeconómica de dos protocolos de tocolisis, que alternativamente utilizan el atosiban o la ritodrinacomo agente tocolítico de primera elección capaz de retrasar el parto durante 48 horas en el tratamiento agudo de la amenaza de parto prematuro en mujeres gestantes. Métodos: La técnica de modelización utilizada para la selección del protocolo más eficiente fue el análisis de decisión. Se realizó una búsqueda bibliográfica de los ensayos clínicos controlados que comparasen la efectividad y/o seguridad del atosiban respecto a la ritodrina en Medline y en la Cochrane Library. En el análisis de costes sólo se consideraron los costes diferenciales. Resultados: La relación coste-efectividad obtenida con el protocolo que utiliza la ritodrina como fármaco de primera elección fue de 194 €/unidad de efectividad y de 632 cuando el tratamiento se inicia con atosiban. El análisis de sensibilidad tan sólo se muestra sensible a una incidencia de edema agudo de pulmón mayor del 8% o a un coste de, al menos, 50.000 €. Conclusión: Un protocolo de tocolisis donde la ritodrina se utiliza como tratamiento de primera elección y el atosiban como tratamiento de rescate es la opción más eficiente, en base a las evidencias disponibles. En mujeres gestantes donde la probabilidad de desarrollar edema agudo de pulmón se asocie a una elevada incidencia o cuando el coste de su tratamiento sea elevado, el atosiban puede ser una alternativa adecuada

Objective: Pharmacoeconomic assessment of two tocolysis protocols alternatively using atosiban or ritodrine as first-choice tocolytic agent able to delay birth for 48 hours in the acute management of premature birth risk in gravid women. Methods: The modeling technique used for the selection of the most efficient protocol was the decision analysis. A search for controlled clinical trials comparing the effectiveness and/or safety of atosiban versus ritodrine was performed in Medline and the Cochrane Library. Only differential costs were considered for cost analysis.Results: Cost-effectiveness obtained with the protocol including ritodrine as first-choice drug was € 194/effectiveness unit,and € 632/effectiveness unit when atosiban is used. The sensitivity analysis shows sensitivity only for an incidence of acute lungedema greater than 8% or a cost of at least € 50,000. Conclusion: A tocolysis protocol using ritodrine as first-choice agent and atosiban as rescue drug is the most efficient option based on available evidence. In pregnant women where the likelihood of developing acute pulmonary edema is high, or when therapy cost is high, atosiban may be an appropriate alternative option