[Lipid emulsion selection in parenteral nutrition. Biochemical and hematological paramaters]. / Selección de emulsiones lipídicas en nutrición parenteral: parámetros bioquímicos y hematológicos.

INTRODUCTION: Lipid emulsions (LE) are a component of parenteral nutrition (PN) and its fatty acid (FA) profile determines various physiological responses. OBJECTIVES: To assess the adequacy of a clinical not restricted protocol in the choice of LE by studying complementary biochemical and hematological parameters (BHP) at the beginning of the PN. METHODS: A 4-year retrospective observational study of LE administered to patients with PN. Demographic, clinical, nutritional and analytical variables at the beginning of the PN were collected. Univariate and multivariate analyses were performed to study the correlation between the initial clinical and biochemical parameters and the LE profile used. RESULTS: Four hundred and sixty patients (29.5%) out of 1,558 had BHP at the beginning of PN and used mainly the LE combinations soybean (SO) + medium-chain triglycerides (MCT) + olive (OO) + fish (FO) (37.4%) and SO + MCT + OO (35.6%). Statistically significant differences on the LE pattern were observed between patients with and those without initial BHP (44.8% vs39.5% received FO, respectively). Conditions regularly associated with elevated C-reactive protein (CRP) were associated with increased use of FO LE: SO+OO+FO (OR: 4.52 [95% CI: 1.43-13.91]) and SO+MCT+OO+FO (OR: 3.34 [95% CI: 2.10-5.33]). In those complex conditions related with the critical patient MCT were used: hepatic failure (SO+MCT OR: 2.42 [95% CI: 1.03-5.68]) and renal failure (SO+MCT+FO OR: 3.34 [95% CI: 1.12-9.99]). CONCLUSIONS: The use of BHP at the beginning of PN treatment allows complementing the clinical and metabolic criteria in LE selection.

INTRODUCCIÓN: el patrón de ácidos grasos (AG) de las emulsiones lipídicas (EL) utilizadas en nutrición parenteral (NP) condiciona diferentes respuestas fisiológicas. OBJETIVOS: estudiar si los criterios clínicos de prescripción de EL en NP establecidos en nuestro protocolo abierto y basados en recomendaciones se correlacionan con marcadores bioquímicos y hematológicos iniciales. MÉTODOS: estudio observacional retrospectivo de cuatro años. Se recogieron variables demográficas, clínicas, nutricionales y analíticas al inicio de la NP. Se realizó un análisis uni y multivariante para estudiar la asociación entre los valores iniciales de los parámetros bioquímicos y hematológicos (PBHE) y el tipo de emulsión lipídica empleada. RESULTADOS: de los 1.558 pacientes, 460 pacientes (29,5%) tenían PBHE al inicio de la NP y utilizaron mayoritariamente las combinaciones soja (AS) + triglicéridos de cadena media (MCT) + oliva (AO) + pescado (AP) (37,4%) y AS+MCT+AO (35,6%). Se encontraron diferencias estadísticamente signifiativas en el patrón EL utilizado entre los pacientes con y sin PBHE: patrón de AG con AP 44,8% vs.39,5%, respectivamente. Las situaciones clínicas con proteína C-reactiva (PCR) elevada se asociaron con mayor uso de EL con AP: AS+AO+AP (OR: 4,52 [IC 95%: 1,43-13,91] y AS+MCT+AO+AP (OR: 3,34 [IC 95%: 2,10-5,33]). En situaciones clínicas complejas asociadas con paciente crítico se utilizó EL con MCT: afectación hepática (AS+MCT OR: 2,42 [IC 95%: 1,03-5,68]) y afectación renal (AS+MCT+AP OR: 3,34 [IC 95%: 1,12-9,99]). CONCLUSIONES: la inclusión protocolizada de PBHE al inicio de la NP permite complementar criterios clínicos y metabólicos en la elección de la EL.

Selección de emulsiones lipídicas en nutrición parenteral: parámetros bioquímicos y hematológicos / Lipid emulsion selection in parenteral nutrition. Biochemical and hematological paramaters

Introducción: el patrón de ácidos grasos (AG) de las emulsiones lipídicas (EL) utilizadas en nutrición parenteral (NP) condiciona diferentes respuestas fisiológicas. Objetivos: estudiar si los criterios clínicos de prescripción de EL en NP establecidos en nuestro protocolo abierto y basados en recomendaciones se correlacionan con marcadores bioquímicos y hematológicos iniciales. Métodos: estudio observacional retrospectivo de cuatro años. Se recogieron variables demográficas, clínicas, nutricionales y analíticas al inicio de la NP. Se realizó un análisis uni y multivariante para estudiar la asociación entre los valores iniciales de los parámetros bioquímicos y hematológicos (PBHE) y el tipo de emulsión lipídica empleada. Resultados: de los 1.558 pacientes, 460 pacientes (29,5%) tenían PBHE al inicio de la NP y utilizaron mayoritariamente las combinaciones soja (AS) + triglicéridos de cadena media (MCT) + oliva (AO) + pescado (AP) (37,4%) y AS+MCT+AO (35,6%). Se encontraron diferencias estadísticamente significativas en el patrón EL utilizado entre los pacientes con y sin PBHE: patrón de AG con AP 44,8% vs. 39,5%, respectivamente. Las situaciones clínicas con proteína C-reactiva (PCR) elevada se asociaron con mayor uso de EL con AP: AS+AO+AP (OR: 4,52 [IC 95%: 1,43-13,91] y AS+MCT+AO+AP (OR: 3,34 [IC 95%: 2,10-5,33]). En situaciones clínicas complejas asociadas con paciente crítico se utilizó EL con MCT: afectación hepática (AS+MCT OR: 2,42 [IC 95%: 1,03-5,68]) y afectación renal (AS+MCT+AP OR: 3,34 [IC 95%: 1,12-9,99]). Conclusiones: la inclusión protocolizada de PBHE al inicio de la NP permite complementar criterios clínicos y metabólicos en la elección de la EL (AU)

Introduction: Lipid emulsions (LE) are a component of parenteral nutrition (PN) and its fatty acid (FA) profile determines various physiological responses. Objectives: To assess the adequacy of a clinical not restricted protocol in the choice of LE by studying complementary biochemical and hematological parameters (BHP) at the beginning of the PN. Methods: A 4-year retrospective observational study of LE administered to patients with PN. Demographic, clinical, nutritional and analytical variables at the beginning of the PN were collected. Univariate and multivariate analyses were performed to study the correlation between the initial clinical and biochemical parameters and the LE profile used. Results: Four hundred and sixty patients (29.5%) out of 1,558 had BHP at the beginning of PN and used mainly the LE combinations soybean (SO) + medium-chain triglycerides (MCT) + olive (OO) + fi sh (FO) (37.4%) and SO + MCT + OO (35.6%). Statistically significant differences on the LE pattern were observed between patients with and those without initial BHP (44.8% vs 39.5% received FO, respectively). Conditions regularly associated with elevated C-reactive protein (CRP) were associated with increased use of FO LE: SO+OO+FO (OR: 4.52 [95% CI: 1.43-13.91]) and SO+MCT+OO+FO (OR: 3.34 [95% CI: 2.10-5.33]). In those complex conditions related with the critical patient MCT were used: hepatic failure (SO+MCT OR: 2.42 [95% CI: 1.03-5.68]) and renal failure (SO+MCT+FO OR: 3.34 [95% CI: 1.12-9.99]). Conclusions: The use of BHP at the beginning of PN treatment allows complementing the clinical and metabolic criteria in LE selection (AU)

The relationship between the parenteral dose of fish oil supplementation and the variation of liver function tests in hospitalized adult patients.

BACKGROUND: Hepatic dysfunction is a complication associated with parenteral nutrition (PN). Our primary objective was to study the relationship between doses of intravenous fish oil (FO) emulsion in PN and the variation in the main liver function tests (LFTs) in hospitalized PN-treated adults. As a secondary objective, we studied the safety of FO administration. METHODS: We conducted a retrospective study in adult patients receiving FO supplementation in PN. Demographic, nutritional and safety variables were collected. Variation of LFTs was defined as the difference between values just before the first administration of FO and values at the end of PN. A multiple linear regression was performed to study the association between PN-lipids (FO or vegetable) and the variation of each LFT; the following variables were used to adjust the effect of lipids: sepsis, length of stay in the intensive care unit and lipids dose. Student t-test was used to study safety variables. Data were analyzed using SPSS 19.0. RESULTS: Patients (53, median age 68 years (24-90); 62% men) with the principal diagnosis of digestive neoplasm (42%) received PN for a median of 19 (7-75) days. In the multivariate analysis, the amount of FO was related to a decrease in gamma-glutamyl transferase (GGT) (B = -2.23;CI95 % = -4.41/-0.05), a decrease in alkaline phosphatase (AP) (B = -1.23;CI95 % = -2.07/-0.37), and a decrease in alanine aminotransferase (ALT) (B = -0.82; CI95 % = -1.19/-0.44). No differences were found in safety variables. CONCLUSIONS: GGT, AP and ALT improved with FO PN-supplementation. Moreover, the improvement was greater when the doses of FO were higher. FO administration in PN is safe.

[Retrospective analysis of omalizumab in patients with severe allergic asthma]. / Estudio observacional retrospectivo de la utilización de omalizumab en el tratamiento del asma grave persistente.

OBJECTIVE: To assess the efficacy and safety profile of omalizumab treatment. The conditions under which omalizumab was prescribed agreed with those in Xolair® drug information: age > 12 years old, severe uncontrolled asthma, FEV1 < 80%, IgE 30-700 UI/ml and positive test results for perennial allergens. METHODS: Asthmatic patients treated with omalizumab between January 2010 and July 2011 were evaluated retrospectively. Age, sex, weight, IgE level, concomitant asthma medications, change in FEV1, emergency department visits, hospitalizations, asthma exacerbations and corticosteroids bursts were recorded before and after omalizumab initiation. A 1.5- year period was chosen. RESULTS: A total of 22 patients were included. The mean weight of subjects was 73 Kg (range, 51-102). Mean IgE was 203 UI/ml (range, 30-992) and mean FEV1 60% (range, 30-93%) at baseline. Adverse events were observed in 4 patients. There were no significant changes in FEV1 values after omalizumab treatment but omalizumab was associated with a reduction in concomitant asthma medications use in 14 patients and improvements in global asthma control in 12. CONCLUSION: In these patients add-on therapy with omalizumab reduced asthma exacerbations and emergency visits or hospitalizations. Only 55% of patients significantly improved global asthma control and no significant changes in FEV1 were observed.

Objetivo: Evaluar la eficacia y seguridad del omalizumab. Las condiciones para la administración de dicho fármaco fueron las indicadas en ficha técnica: edad superior a 12 años, asma alérgica grave persistente, mal control de síntomas, FEV1<80%, IgE total entre 30 y 700 UI/mL y pruebas cutáneas y/o IgE específica positiva al alérgeno persistente. Método: Estudio retrospectivo observacional de pacientes que hubieran sido tratados con omalizumab en la indicación de asma grave durante el período enero 2010 a julio de 2011. Se registraron la edad, sexo, peso, IgE y reactividad in vitro a los alergenos perennes, FEV1, tratamiento de base, exacerbaciones asmáticas y necesidad de corticosteroides sistémicos o ingresos en urgencias, presencia de síntomas durante el día o que originen despertares durante la noche al inicio del tratamiento, a las 16 semanas, 32 semanas y a los 1,5 años tras al inicio del tratamiento. Se recogieron los efectos secundarios y los cambios en el tratamiento de base. Resultados: 22 pacientes con un peso medio de 73 kg (51-102). La concentración basal de IgE antes del inicio de omalizumab fue de 203 UI/ml (30-992). 21 pacientes presentaban una función pulmonar reducida, con un FEV1 al inicio del 60% (30-93%). El FEV1 a las 16 semanas fue del 60% (39-71%) y a las 32 semanas del 68% (29-102%). La dosis media de omalizumab administrada cada 30 días fue de 368 mg (150- 900 mg). Se observaron reacciones adversas en 4 pacientes, uno de los cuales requirió la retirada del tratamiento. Al final del periodo de seguimiento 14 pacientes habían disminuido el tratamiento control y doce presentaron mejoría global. Conclusión: Omalizumab se ha utilizado en pacientes con asma grave alérgica no respondedores a terapia convencional observándose una disminución en el número de exacerbaciones y visitas a urgencias e ingresos. Sólo un 55% experimentan una mejoría global según criterios clínicos y no se observaron cambios estadísticamente significativos en la FEV1.

Estudio observacional retrospectivo de la utilización de omalizumab en el tratamiento del asma grave persistente / Retrospective analysis of omalizumab in patients with severe allergic asthma

Objetivo: Evaluar la eficacia y seguridad del omalizumab. Las condiciones para la administración de dicho fármaco fueron las indicadas en ficha técnica: edad superior a 12 años, asma alérgica grave persistente, mal control de síntomas, FEV1<80%, IgE total entre 30 y 700 UI/mL y pruebas cutáneas y/o IgE específica positiva al alérgeno persistente. Método: Estudio retrospectivo observacional de pacientes que hubieran sido tratados con omalizumab en la indicación de asma grave durante el período enero 2010 a julio de 2011. Se registraron la edad, sexo, peso, IgE y reactividad in vitro a los alergenos perennes, FEV1, tratamiento de base, exacerbaciones asmáticas y necesidad de corticosteroides sistémicos o ingresos en urgencias, presencia de síntomas durante el día o que originen despertares durante la noche al inicio del tratamiento, a las 16 semanas, 32 semanas y a los 1,5 años tras al inicio del tratamiento. Se recogieron los efectos secundarios y los cambios en el tratamiento de base. Resultados: 22 pacientes con un peso medio de 73 kg (51-102). La concentración basal de IgE antes del inicio de omalizumab fue de 203 UI/ml (30-992). 21 pacientes presentaban una función pulmonar reducida, con un FEV1al inicio del 60% (30-93%). El FEV1 a las 16 semanas fue del 60% (39-71%) y a las 32 semanas del 68% (29-102%). La dosis media de omalizumab administrada cada 30 días fue de 368 mg (150900 mg). Se observaron reacciones adversas en 4 pacientes, uno de los cuales requirió la retirada del tratamiento. Al final del periodo de seguimiento 14 pacientes habían disminuido el tratamiento control y doce presentaron mejoría global. Conclusión: Omalizumab se ha utilizado en pacientes con asma grave alérgica no respondedores a terapia convencional observándose una disminución en el número de exacerbaciones y visitas a urgencias e ingresos. Sólo un 55% experimentan una mejoría global según criterios clínicos y no se observaron cambios estadísticamente significativos en la FEV1 (AU)

Objective: To assess the efficacy and safety profile of omalizumab treatment. The conditions under which omalizumab was prescribed agreed with those in Xolair® drug information: age > 12 years old, severe uncontrolled asthma, FEV, < 80%, IgE 30-700 UI/ml and positive test results for perennial allergens. Methods: Asthmatic patients treated with omalizumab between January 2010 and July 2011 were evaluated retrospectively. Age, sex, weight, IgE level, concomitant asthma medications, change in FEV1, emergency department visits, hospitalizations, asthma exacerbations and corticosteroids bursts were recorded before and after omalizumab initiation. A 1.5-year period was chosen. Results: A total of 22 patients were included. The mean weight of subjects was 73 Kg (range, 51-102). Mean IgE was 203 UI/ml (range, 30-992) and mean FEV1 60% (range, 30-93%) at baseline. Adverse events were observed in 4 patients. There were no significant changes in FEV1 values after omalizumab treatment but omalizumab was associated with a reduction in concomitant asthma medications use in 14 patients and improvements in global asthma control in 12.Conclusion: In these patients add-on therapy with omalizumab reduced asthma exacerbations and emergency visits or hospitalizations. Only 55% of patients significantly improved global asthma control and no significant changes in FEV1, were observed. mejoría global según criterios clínicos y no se observaron cambios estadísticamente significativos en la FEV1 (AU)

Utilización de eritropoyetina beta pegilada en enfermedad renal crónica en estadio 3, 4 o 5 no-D / Use of methoxy polyethylene glycol-epoetin beta in stage 3, 4 or 5 non-dialysis chronic kidney disease

Antecedentes: La eritropoyetina beta pegilada (PegEPO) está indicada en el tratamiento de la anemia por enfermedad renal crónica. Su larga semivida permite su administración mensual en fases de mantenimiento. Objetivo: Evaluar el uso, efectividad y coste de PegEPO en un grupo de pacientes con insuficiencia renal crónica en estadio prediálisis. Método: Estudio observacional retrospectivo en pacientes prediálisis que iniciaron tratamiento con PegEPO entre mayo de 2008 y febrero de 2009. Se recogieron: edad, sexo, niveles de hemoglobina (Hb) y dosis y frecuencia del agente estimulante de eritropoyesis (AEE) utilizado. El período de seguimiento fue de 12 meses. Resultados: Se incluyeron 198 pacientes. La Hb media al inicio de PegEPO en pacientes sin tratamiento previo fue de 10,8 g/l y de 11,6 g/l a los 90 días (p < 0,0001). En pacientes con AEE previo, la Hb media al inicio de PegEPO fue de 11,2 g/l y de 11,4 g/l a los 12 meses de tratamiento (p = 0,846). El 25% de los pacientes presentaron valores de Hb superiores a 12 g/l (p < 0,0001) a los 12 meses del inicio del tratamiento, de los cuales un 45% superó los 13 g/l. Se observa la utilización de dosis un 39% menores de las indicadas en ficha técnica y, como consecuencia, un coste inferior respecto al teórico esperado. Conclusiones: Las dosis utilizadas de PegEPO en pacientes con AAE previo fueron inferiores a las indicadas en ficha técnica manteniéndose estable la Hb a los 12 meses del inicio. Una mayor proporción de pacientes superan el límite de 13 g/l (AU)

Background: Methoxy polyethylene glycol-epoetin beta (PEG-EPO) is indicated for the treatment of anaemia due to chronic kidney disease. Its long half-life allows it to be administered monthly during maintenance phases. Objective: Evaluate the use, effectiveness and cost of PEG-EPO in a group of pre-dialysis chronic renal failure patients. Method: Retrospective observational study in pre-dialysis patients who began treatment with PEG-EPO between May 2008 and February 2009. The following data were gathered: age, sex, haemoglobin levels (Hb) and erythropoiesis-stimulating agent (ESA) dose and frequency. The follow-up period was 12 months. Results: We included 198 patients. Mean Hb upon starting PEG-EPO in patients ho had received no prior treatment was 18.8g/l, and 11.6g/l at 90 days (P<.0001). In patients previously treated with ESA, mean Hb before starting PEG-EPO treatment was 11.2g/l, and 11.4g/l at 12 months (P=.846). Hb values were higher than 12g/l (P<.0001) after 12 months of treatment in 25% of the patients; of these, 45% had values above 13g/l. We observed use of doses 39% lower than those indicated on the drug leaflet, resulting in a reduction in the originally expected theoretical costs. Conclusions: The doses of PEG-EPO administered to patients with a prior history of ESA treatment were lower than those indicated by the drug leaflet, and Hb remained stable after 12 months of treatment. A large part of the patients had levels above the 13g/l threshold (AU)

Use of methoxy polyethylene glycol-epoetin beta in stage 3, 4 or 5 non-dialysis chronic kidney disease.

BACKGROUND: Methoxy polyethylene glycol-epoetin beta (PEG-EPO) is indicated for the treatment of anaemia due to chronic kidney disease. Its long half-life allows it to be administered once per month in maintenance therapy. OBJECTIVE: To evaluate the use, effectiveness and cost of PEG-EPO in a group of pre-dialysis chronic renal failure patients. METHOD: Retrospective observational study in pre-dialysis patients who began treatment with PEG-EPO between May 2008 and February 2009. The following data were gathered: age, sex, haemoglobin levels (Hb) and erythropoiesis-stimulating agent (ESA) dose and frequency. The follow-up period was 12 months. RESULTS: We included 198 patients. Mean Hb upon starting PEG-EPO in patients who had received no prior treatment was 10.8g/l, and 11.6g/l at 90 days (P<.0001). In patients previously treated with ESA, mean Hb before starting PEG-EPO treatment was 11.2g/l, and 11.4g/l at 12 months (P=.846). Hb values were higher than 12g/l (P<.0001) after 12 months of treatment in 25% of patients; of these, 45% had values above 13g/l. We observed doses 39% lower than those indicated on the drug leaflet, resulting in a reduction in the originally expected theoretical costs. CONCLUSIONS: The doses of PEG-EPO administered to patients with a prior history of ESA treatment were lower than those indicated by the drug leaflet, and Hb remained stable after 12 months of treatment. A large portion of the patients had levels above the 13g/l threshold.

A randomised study on the clinical progress of high-risk elective major gastrointestinal surgery patients treated with olive oil-based parenteral nutrition with or without a fish oil supplement.

n-3 Fatty acids have clinical benefits. The primary aim of the present study was the assessment of infection in patients who underwent major high-risk elective gastrointestinal surgery receiving postoperatively fish oil (FO)-supplemented parenteral nutrition (PN), compared with those receiving a standard olive oil (OO) emulsion. The secondary aims were the assessment of anti-inflammatory response and evaluation of tolerance and safety of these emulsions. A prospective, randomised, double-blind study was performed in patients requiring at least 5 d of PN. An isoenergetic and isoproteic formula was administered: group A received OO alone, while group B received OO that was partially replaced with FO (16.6 %, w/w). End points were outcome measures (mortality, sepsis, infection, hospitalisation days and PN duration), inflammatory response (C-reactive protein (CRP), prealbumin and leucocytes) and safety (TAG and glucose metabolism, and liver and kidney function). Statistical analysis was done using Student's t test and Fisher's exact test (P < 0.05). Twenty-seven patients were evaluated, with thirteen patients receiving FO. In this group, a significantly lower incidence of infections was found (23.1 v. 78.6 %, P = 0.007). CRP, prealbumin and leucocytes were not significantly different between the groups. There were no differences in safety parameters. We conclude that high-risk surgical patients receiving FO-supplemented PN for 5 d present a lower incidence of infection. Emulsions were safe and well tolerated.

Retrospective assessment of potential interaction between levofloxacin and warfarin.

OBJECTIVE: There is currently a controversy regarding interactions between levofloxacin and warfarin. The aim of this study was to determine the clinical relevance of this interaction in our setting. SETTING: A university hospital in Barcelona, Spain. METHODS: We carried out a retrospective evaluation of all patients hospitalized in our hospital during the period 2000-2005, selecting all those concomitantly treated with levofloxacin and warfarin for the study. The following data were compiled: demographic information, concomitant medication, comorbid conditions, and relevant analytical parameters, particularly the international normalized ratio (INR), including values taken before, during, and after concomitant administration of the two study drugs. Patients for whom INR values during concomitant administration were not available were excluded. Differences in INR before and during the potential interaction, and before and after the interaction were analyzed with the Wilcoxon t test using SPSS (V12.0). In addition, patients were stratified according to presence or not of toxic habits (smoking/alcohol consumption) to investigate the possible impact of these factors on the interaction under study. RESULTS: Among the 30 patients identified, 9 were excluded because INR data during concomitant administration of warfarin and levofloxacin were not available. Statistical analysis demonstrated significant increase in INR (P = 0.001) following addition of levofloxacin to warfarin therapy. CONCLUSIONS: The results of this study reaffirm the hypothesis that concomitant administration of levofloxacin and warfarin leads to INR increase; hence close monitoring of INR is advisable when patients are prescribed this combination of drugs.