Impact of proactive of infliximab monitoring using the Bayesian approach in the maintenance phase in patients with inflammatory bowel disease / Impacto de la monitorización proactiva de infliximab en fase de mantenimiento mediante estimación bayesiana en pacientes con enfermedad inflamatoria intestinal

Background and objectives: There is increasing evidence that proactive monitoring is useful in improving the control of inflammatory bowel disease, although it remains controversial. The aim of this study was to evaluate the efficacy of proactive TDM based on the Bayesian approach to optimise the IFX dose compared with the standard of care dosing in patients with IBD. Methods: Retrospective observational cohort of inflammatory bowel disease patients>18 years. Patients were classified into two groups according to the strategy used to optimise the dose of IFX: a standard therapy group (ST-group) with clinically based dose adjustment and therapeutic drug monitoring group (TDM-group), with estimation of pharmacokinetic parameters calculated by Bayesian prediction. Results: A total of 153 patients were included. Of these, 75 were in the TDM-group. Clinical response at week 52 was evaluated in 114 patients. The proportion of patients who achieved clinical remission was higher in the TDM than in the ST-group (80.7% vs 61.4%, respectively, p=0.023). A total of 28 patients (24.6%) met the parameters for the composite variable ‘poor clinical outcome’ at week 52. The proportion of patients who reached this outcome was lower in the TDM-group than in the ST-group (12.3% vs 36.8%, respectively, p=0.002). Conclusions: Proactive therapeutic drug monitoring using Bayesian approach is associated with higher secondary response and fewer long-term complications.(AU)

Antecedentes y objetivos: Cada vez hay más evidencia de que la monitorización proactiva es útil para mejorar el control de la enfermedad inflamatoria intestinal (EII), aunque sigue siendo controvertida. El objetivo de este estudio fue evaluar la eficacia de la monitorización de fármacos terapéuticos (TDM) proactiva basada en el enfoque bayesiano en comparación con el manejo estándar en pacientes con EII. Métodos: Cohorte observacional retrospectiva de pacientes con EEI > 18 años. Los pacientes se clasificaron en dos grupos de acuerdo con la estrategia utilizada para optimizar la dosis de infliximab (IFX): un grupo de terapia estándar (grupo-ST) con ajuste de dosis basado en la clínica y un grupo de monitorización terapéutica del fármaco (grupo-TDM), con estimación de parámetros farmacocinéticos calculados mediante estimación bayesiana. Resultados: Se incluyeron un total de 153 pacientes. De estos, 75 estaban en el grupo-TDM. La respuesta clínica en la semana 52 se evaluó en 114 pacientes. La proporción de pacientes que alcanzaron la remisión clínica fue mayor en el grupo-TDM que en el grupo-ST (80,7 vs. 61,4%, respectivamente, p = 0,023). Un total de 28 pacientes (24,6%) cumplieron los parámetros de la variable compuesta «resultado clínico deficiente» en la semana 52. La proporción de pacientes que alcanzaron este resultado fue menor en el grupo-TDM que en el grupo-ST (12,3 vs. 36,8%, respectivamente, p = 0,002). Conclusiones: La TDM proactiva mediante el enfoque bayesiano se asocia con una mayor respuesta secundaria y menos complicaciones a largo plazo.(AU)

Comparative effectiveness and drug survival of biosimilar infliximab CPT-13 vs. reference infliximab in inflammatory bowel disease: A retrospective cohort study.

BACKGROUND: Studies have investigated the efficacy and safety of switching to the biosimilar infliximab (CT-P13) in patients with inflammatory bowel disease (IBD). However, there is limited research directly comparing the effectiveness, drug survival, and pharmacokinetic profiles of the reference infliximab (IFX) and CT-P13 in real clinical settings. OBJECTIVE: To compare the effectiveness and drug survival of CPT-13 and reference IFX at weeks 26 and 52, and to determine the pharmacokinetic profiles and safety profile in real-world settings. METHODS: A retrospective observational cohort analysis was conducted at a single center. The study compared the proportion of patients achieving clinical remission and experiencing poor clinical outcomes at weeks 26 and 52. The drug survival rate of CT-P13 and reference infliximab was also assessed during the follow-up period. RESULTS: A total of 153 patients were included in the study, 39.2% receiving CPT-13 and 60.8% reference IFX. At week 26, clinical remission rates were 66.7% (CPT-13: 74.4% vs. reference IFX: 62.3%, p=0.178), and at week 52, they were 64% (CPT-13: 85.4% vs. reference IFX: 63.0%, p=0.012). Subgroup analysis with therapeutic drug monitoring (TDM) found no significant differences at week 26 (CPT-13: 74.4% vs. reference IFX: 58.8%, p=0.235) or at week 52 (CPT-13: 85.4% vs. reference IFX: 68.8%, p=0.153). CONCLUSION: Our study demonstrates comparable efficacy, drug survival, pharmacokinetic profiles, and incidence of immunogenicity between both drugs in a real clinical setting. Further studies with greater statistical power are needed to validate these findings.

Impact of proactive therapeutic drug monitoring of infliximab during the induction phase in IBD patients. A Bayesian approach.

BACKGROUND AND OBJECTIVES: there is increasing evidence that proactive therapeutic drug monitoring in induction is useful to improve the control of inflammatory bowel disease (IBD), although it remains controversial. The primary objective of the study was to assess the short-term outcomes of proactive Bayesian therapeutic drug monitoring (TDM) during induction, to optimize infliximab (IFX) maintenance dose. METHODS: retrospective observational cohort of IBD patients > 18 years. They were divided into two cohorts, standard therapy group (ST-group), with clinically based dose adjustment, and monitoring group (iTDM-group), with pharmacokinetic parameters calculated by Bayesian prediction at week 6 and individualized dosage regimens thereafter. In patients with an infliximab trough level (ITL) at week 6 below the optimal therapeutic range, the dose adjustment was performed at the first maintenance dose. RESULTS: a total of 153 patients were included, 40 in the iTDM-group. Median ITL at week 6 during the induction period was 12.8 µg/ml (IRQ: 12.7) in this group. Only 16 patients (40.0 %) had ITL ≥ 15 µg/ml. Half of the patients (50.3 %) received intensified maintenance therapy during the study period (57.5 % iTDM vs 47.8 % ST, p = 0.291). The proportion of patients achieving primary response at week 14 was 51.8 %. When comparing the two groups, this proportion was higher in the iTDM group (74.3 % vs 44.2 %, p = 0.002). With regards to the variable "poor clinical outcomes" at week 26, this proportion was lower in the iTDM group (3.3 % iTDM vs 21.1 % ST, p = 0.024). CONCLUSIONS: proactive therapeutic drug monitoring using Bayesian approach is associated with higher primary response rates and fewer short-term complications.

Impact of proactive therapeutic drug monitoring of infliximab during the induction phase in IBD patients. A Bayesian approach

Background and objectives: there is increasing evidence that proactive therapeutic drug monitoring in induction is useful to improve the control of inflammatory bowel disease (IBD), although it remains controversial. The primary objective of the study was to assess the short-term outcomes of proactive Bayesian therapeutic drug monitoring (TDM) during induction, to optimize infliximab (IFX) maintenance dose. Methods: retrospective observational cohort of IBD patients > 18 years. They were divided into two cohorts, standard therapy group (ST-group), with clinically based dose adjustment, and monitoring group (iTDM-group), with pharmacokinetic parameters calculated by Bayesian prediction at week 6 and individualized dosage regimens thereafter. In patients with an infliximab trough level (ITL) at week 6 below the optimal therapeutic range, the dose adjustment was performed at the first maintenance dose. Results: a total of 153 patients were included, 40 in the iTDM-group. Median ITL at week 6 during the induction period was 12.8 µg/ml (IRQ: 12.7) in this group. Only 16 patients (40.0 %) had ITL ≥ 15 µg/ml. Half of the patients (50.3 %) received intensified maintenance therapy during the study period (57.5 % iTDM vs 47.8 % ST, p = 0.291). The proportion of patients achieving primary response at week 14 was 51.8 %. When comparing the two groups, this proportion was higher in the iTDM group (74.3 % vs 44.2 %, p = 0.002). With regards to the variable “poor clinical outcomes” at week 26, this proportion was lower in the iTDM group (3.3 % iTDM vs 21.1 % ST, p = 0.024). Conclusions: proactive therapeutic drug monitoring using Bayesian approach is associated with higher primary response rates and fewer short-term complications (AU)

Postoperative Diet with an Oligomeric Hyperproteic Normocaloric Supplement versus a Supplement with Immunonutrients in Colorectal Cancer Surgery: Results of a Multicenter, Double-Blind, Randomized Clinical Trial.

(1) Background: For normo-nourished colorectal cancer patients, the need for immunonutrients after elective surgery is not known. (2) Methods: Multicenter, randomized, double-blind, phase III clinical trial comparing the postoperative diet with 200 mL oligomeric hyperproteic normocaloric (OHN; experimental arm) supplement vs. 200 mL immunonutritional (IN) (active comparator) supplement twice a day for five days in 151 normo-nourished adult colorectal-resection patients following the multimodal rehabilitation ERAS protocol. The proportions of patients with complications (primary outcome) and those who were readmitted, hospitalized for <7 days, had surgical site infections, or died due to surgical complications (secondary outcome) were compared between the two groups until postoperative day 30. Tolerance to both types of supplement and blood parameters was also assessed until day 5. (3) Results: Mean age was 69.2 and 84 (58.7%) were men. Complications were reported in 41 (28.7%) patients and the incidence did not differ between groups (18 (25%) vs. 23 (32.4%) patients with OHN and IN supplement, respectively; p = 0.328). No significant differences were found for the rest of the variables. (4) Conclusions: IN supplement may not be necessary for the postoperative recovery of colorectal cancer patients under the ERAS regimen and with normal nutritional status at the time of surgery.

Biosimilar infliximab CPT-13 for inflammatory bowel disease in a real clinical setting: pharmacokinetic outcomes, immunogenicity, and drug survival.

BACKGROUND: efficacy and safety were evaluated after switching to a biosimilar infliximab (CPT-13) in patients with inflammatory bowel disease (IBD). However, few cohort studies compare the pharmacokinetic profiles, immunogenicity, and safety of the reference infliximab (IFX) and CPT-13 in a real clinical setting. OBJECTIVE: to compare the pharmacokinetic profiles and drug survival on the long term of reference IFX and CPT-13 at weeks 54 and 104. A secondary objective was to determine the long-term immunogenicity and safety profile of CPT-13 in patients with IBD in a real clinical setting. METHODS: a retrospective, observational cohort analysis was performed in a single center, including patients with IBD under treatment with reference IFX or CPT-13. Serum drug concentrations were compared to determine if there were any significant differences in pharmacokinetic outcomes between reference IFX and CPT-13 at 26, 54, 78, and 104 weeks. The drug survival of reference IFX and CPT-13 was determined at weeks 54 and 104. RESULTS: one hundred and six patients were included during the study period. Forty-five (42.5 %) patients received CPT-13 and 61 (57.5 %) received reference IFX. A total of 347 serum samples were analyzed and no significant differences were observed between reference IFX and CPT-13. The percentage of patients who achieved serum concentrations within the target therapeutic range was similar in both groups (74.1 % for reference IFX and 72.5 % for CPT-13, p = 0.741). At week 54, withdrawal rates for reference IFX and CPT-13 were 11.5 % and 20.0 %, respectively (p = 0.226), whereas at week 104 they were 26.2 % and 28.9 %, respectively (p = 0.761). CONCLUSION: the pharmacokinetic characteristics and incidence of immunogenicity of CPT-13 in a real clinical setting are comparable to those of the infliximab originator. The two products also have similar long-term drug survival and the same safety profile.

Association between ustekinumab trough concentrations and biochemical outcomes in patients with Crohn's disease. A real life study.

INTRODUCTION: numerous studies have shown a positive correlation between serum biologic drug concentrations and favorable therapeutic outcomes during the induction and maintenance period in patients with Crohn's disease (CD). To our knowledge, only a few and contradictory studies have determined the association between ustekinumab (UST) trough concentrations and biological outcomes. This study aimed to investigate the relationship between ustekinumab trough concentrations and biological outcomes in a real-world setting. METHODS: a cross-sectional cohort study was performed. All adult patients with CD who received maintenance therapy (≥ 24 weeks) with ustekinumab were included in the study. Clinical response was determined using the Harvey-Bradshaw Index. Biochemical remission was defined as a fecal calprotectin level < 150 µg/g in feces and a biochemical response as > 50 % reduction of fecal calprotectin. RESULTS: a total of 58 CD patients were included in the study and the median UST trough concentration was 1.78 µg/ml (IQR: 2.56). Differences in ustekinumab trough concentrations were observed for clinical (2.25 µg/ml vs 0.65 µg/ml; p = 0.006) and biochemical remission (2.33 µg/ml vs 1.03 µg/ml; p = 0.047). According to ROC analysis, a cut-off of 1.4 µg/ml (AUC: 077) and 2.0 µg/ml (AUC: 0.65) were identified for predicting clinical and biochemical remission, respectively. Likewise, ustekinumab trough levels were also higher in "composite clinical/biochemical remission" (2.38 µg/ml vs 1.08 µg/ml; p = 0.042). The trough level that was best associated with composite clinical/biochemical remission was 2.2 µg/ml (AUC: 0.69). CONCLUSION: this real-life study shows the association between ustekinumab trough concentration and clinical and biochemical remission and we suggest an optimal cut-off point higher than 2.2 µg/ml. Further studies are needed to confirm the findings and to identify the optimal cut-off in different disease outcomes and disease phenotypes.

Usefulness of population pharmacokinetics to optimize the dosage regimen of infliximab in inflammatory bowel disease patients

INTRODUCTION: infliximab is used in inflammatory bowel disease, which has a great inter-individual pharmacokinetic variability. Thus, it is necessary to individualize the therapy in many cases. The main objective of our study was to compare two methods of a dose adjustment strategy using therapeutic drug monitoring: a) based on an algorithm and b) based on Bayesian prediction, to achieve an optimal infliximab trough level in patients with inflammatory bowel diseases. The secondary objective was to evaluate the predictive performance of a population pharmacokinetic model of infliximab in patients with inflammatory bowel diseases and therefore, its clinical utility. Furthermore, the factors associated with a suboptimal adjustment of the model were analyzed. METHODS: a retrospective observational cohort analysis was performed of patients with inflammatory bowel disease and available serum levels of infliximab. The relationship between trough concentration and dosing strategy was compared in both groups. The external validation of a previously published population pharmacokinetic model was performed using the NONMEM software. The mean prediction error and mean absolute prediction error were calculated to evaluate the predictive performance of the model. RESULTS: a total of 94 infliximab serum samples were obtained from 47 patients. After the adjustment, a total of 30 patients (63.8 %) achieved optimal infliximab trough levels. A dosing strategy based on Bayesian was associated with optimal infliximab trough levels that were higher than the strategy based on an algorithm (OR: 8.94 [95 % CI: 2.24 - 35.6], p = 0.001). For the individual predictions, the mean prediction error was 0.118 Mug/ml (95 % CI: -0.149-0.384) and the mean absolute prediction error was 0.935 Mug/ml (95 % CI: 0.569-1.075). CONCLUSIONS: the application of a population pharmacokinetic model based on Bayesian prediction is an important advance in the optimization of infliximab dosage in the treatment of inflammatory bowel disease

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Usefulness of population pharmacokinetics to optimize the dosage regimen of infliximab in inflammatory bowel disease patients.

INTRODUCTION: infliximab is used in inflammatory bowel disease, which has a great inter-individual pharmacokinetic variability. Thus, it is necessary to individualize the therapy in many cases. The main objective of our study was to compare two methods of a dose adjustment strategy using therapeutic drug monitoring: a) based on an algorithm and b) based on Bayesian prediction, to achieve an optimal infliximab trough level in patients with inflammatory bowel diseases. The secondary objective was to evaluate the predictive performance of a population pharmacokinetic model of infliximab in patients with inflammatory bowel diseases and therefore, its clinical utility. Furthermore, the factors associated with a suboptimal adjustment of the model were analyzed. METHODS: a retrospective observational cohort analysis was performed of patients with inflammatory bowel disease and available serum levels of infliximab. The relationship between trough concentration and dosing strategy was compared in both groups. The external validation of a previously published population pharmacokinetic model was performed using the NONMEM software. The mean prediction error and mean absolute prediction error were calculated to evaluate the predictive performance of the model. RESULTS: a total of 94 infliximab serum samples were obtained from 47 patients. After the adjustment, a total of 30 patients (63.8 %) achieved optimal infliximab trough levels. A dosing strategy based on Bayesian was associated with optimal infliximab trough levels that were higher than the strategy based on an algorithm (OR: 8.94 [95 % CI: 2.24 - 35.6], p = 0.001). For the individual predictions, the mean prediction error was 0.118 µg/ml (95 % CI: -0.149-0.384) and the mean absolute prediction error was 0.935 µg/ml (95 % CI: 0.569-1.075). CONCLUSIONS: the application of a population pharmacokinetic model based on Bayesian prediction is an important advance in the optimization of infliximab dosage in the treatment of inflammatory bowel disease.

Comparison of drug survival between infliximab and adalimumab in inflammatory bowel disease.

Background Conventional therapy of inflammatory bowel disease with traditional immunosuppressant medication is increasingly being replaced by biological agents. However, the response to these biological agents may be lost over time, with discontinuation being a marker of loss of effectiveness. There are few published reports on the treatment drug survival of infliximab and adalimumab in patients with inflammatory bowel disease. Objective This study compared the drug survival of infliximab versus adalimumab as first- and second-line treatments, identified factors associated with drug survival, and described reasons for treatment withdrawal. Setting A pharmacy department of a university hospital in Spain. Method A retrospective single-centre cohort study of all patients with inflammatory bowel disease treated with biological agents between 2008 and 2017 at a regional referral hospital. The primary outcome was drug survival and associated factors during a follow-up of 52 months. Main outcome measure Drug survival of infliximab versus adalimumab. Results One hundred thirty-four patients with inflammatory bowel disease (73.9% Crohn's disease and 26.1% ulcerative colitis) were treated with biological therapy. The overall mean drug survival of first-line treatment with an anti-tumour necrosis factor agent was 18.6 months (SD 14.9), with mean values of 20.2 months (SD 16.6) for adalimumab and 17.1 months (SD 13.1) for infliximab. As a second-line treatment, the drug survival of anti-tumour necrosis factor agents was 17.9 months (SD 15.6), with mean values of 22.9 months (SD 17.1) for adalimumab and 12.5 months (SD 11.7) for infliximab. The difference in time to discontinuation at 52 months of follow-up between the infliximab and adalimumab subgroups, as either first- or second-line treatment, was not statistically significant (p = 0.547 and p = 0.676, respectively). Therapeutic drug monitoring was the only factor associated with greater drug survival in first-line treatment (HR 0.27; 95% confidence interval, CI 0.15-0.50) and second-line treatment (HR 0.26; 95% CI 0.10-0.65). Secondary failure to treatment was the most frequent reason for withdrawal. Conclusion Infliximab and adalimumab showed similar drug survival as first- and second-line anti-tumour necrosis factor treatments. Therapeutic drug monitoring was associated with higher drug survival for both first- and second-line anti-tumour necrosis factor treatments.

Effect of drug interactions involving antiretroviral drugs on viral load in HIV population.

BACKGROUND: Most studies focus on potential drug interactions, without considering the effect of these on the response to antiretroviral (ARV) therapy. We assess the effect of potential drug-drug interactions (pDDIs) that could have lowered the ARV concentration (pDDI-lowerARV) on HIV viral load. METHODS: Retrospective observational cohort study was conducted on all HIV-infected outpatients attending the Pharmacy Service of a regional reference hospital in Murcia (south-eastern Spain). The complete treatment was subsequently screened for pDDIs using the database 'InteraccionesHIV.com'. The study focused on interactions involving at least one ARV drug and, especially, any pDDI-lowerARV. RESULTS: Two hundred and twenty-nine patients were included in the study. A total of 168 pDDIs were identified, of which 62 (36.9%) had the potential to lower ARV concentrations. In 77% of cases, the drug involved in the reduction of plasma concentrations was a protease inhibitor (PI), and in the rest of the drug interactions the ARV drug affected was a non-nucleoside reverse-transcriptase inhibitor. Baseline viral suppression was noted in 57.1% of patients with pDDI-lowerARV compared with 61.5% of patients without pDDI-lowerARV (p=0.605), and in 85.7% versus 79.7%, respectively, after a 24-week follow-up period (p=0.516). CONCLUSIONS: This study shows that prevalence of pDDI-lowerARV was high; however, no association was found between the presence of these interactions and virological failure. These results confirm the need for further studies to understand the consequences of interactions in real-life clinical practice, since most pharmacokinetic studies tend to evaluate the ability of interaction between two drugs under controlled conditions.

[MALNUTRITION IN THE ELDERLY PATIENT TO HOSPITAL ADMISSION, AN OLD PROBLEM UNSOLVED]. / DESNUTRICIÓN EN EL PACIENTE ANCIANO AL INGRESO HOSPITALARIO, UN VIEJO PROBLEMA SIN SOLUCIONAR.

OBJETIVE: to determine the prevalence of malnutrition in patients aged 65 years or more at admission and factors associated with its presence. Analyze excess hospital stay (EHS), economic impact and premature readmission rate associated with hospital malnutrition in elderly patient. MATERIAL AND METHOD: retrospective study conducted at the University Hospital Reina Sofía. All patients aged 65 years or older admitted to internal medicine in 2011. The sample size was calculated taking into account the income of the previous year, and considering a prevalence of malnutrition of 50% with a 95% and included error of 5%. To define the degree of malnutrition nutritional control tool (CONUT), which establishes a score based on albumin, total cholesterol and lymphocyte determination was used. To determine the factors associated with the presence of moderate to severe malnutrition analysis of multivariate logistic regression was performed. For each patient the EHS, premature readmissions and the associated cost to EHS was calculated. A threshold of statistical significance of 0.05 was used for all analyzes and were performed with SPSS v15.0. RESULTS: 310 patients, of whom 54.2% were women were included, the mean age was 80.1 years (SD: 6.8), ranging between 65 and 95 years. Regarding diagnosis at admission 27.4% were respiratory diseases, 22.6% of the circulatory and digestive 11.6%. The median Charlson index was 2.0, found that 36.8% of patients had high comorbidity. The most prevalent chronic diseases were diabetes mellitus (44.2%), chronic kidney disease (25.2%) and dementia (10.6). Regarding the CONUT, 75.8% of patients met the criteria of malnutrition: 42.6% mild, 28.7% moderate and severe 4.5%, of which only 46.6% had some nutritional support during admission. Factors associated with the presence of moderate to severe malnutrition were female gender (OR: 1.7; 95%: 1.1 - 2.8), age over 80 years (OR: 2.0, IC 95%: 1.2 - 3.5), and dementia (OR: 2.4; IC 95%:1.2 - 5.2). No association with comorbidity or with other chronic diseases was found. Regarding the EHS (days) differences between patients with moderate to severe malnutrition (4.7; IC 95%: 2.3 - 7.1) and normally nourished (-0.1; IC 95%: -1.4 - 1.2) (p = 0.001) were found, but were not for cases of mild malnutrition (1.6, 95%: 0.5-2.8) (p = 0.07).Regarding the rate of premature readmission in malnourished patients was 28/235 (11.9%). The cost associated with EHS / 100 patients was € 195 479.4 for moderate malnutrition, mild malnutrition € 73 484.8, and normally nourished patients represented a saving of € 12 353. CONCLUSIONS: hospital malnutrition in elderly patients remains an unsolved problem, given the high prevalence found, associated to an excess of hospital stay and increased hospital costs, especially in patients with moderate to severe malnutrition. The CONUT is a nutritional screening tool very useful for the speed and validity of their results, and allows detecting patients at risk or nutritional alert without lead to increased costs.

Objetivo: determinar la prevalencia de desnutrición en pacientes con edad igual o superior a 65 años al ingreso hospitalario y los factores asociados a su presencia. Analizar el exceso de estancia hospitalaria (EEH), el impacto económico y la tasa de reingresos prematuros asociados a la desnutrición hospitalaria en pacientes de edad avanzada. Material y métodos: estudio retrospectivo realizado en el Hospital Universitario Reina Sofía. Se incluyeron todos los pacientes con edad igual o mayor a 65 años que ingresaron en Medicina Interna durante 2011. Se calculó el tamaño muestral teniendo en cuenta los ingresos del año anterior, y considerando una prevalencia de desnutrición del 50% con un IC 95% y un error del 5%. Para definir el grado de desnutrición se empleó la herramienta Control Nutricional (CONUT), que establece una puntuación basada en la determinación de albúmina, colesterol total y linfocitos. Para determinar los factores asociados a la presencia de desnutrición moderada-grave se realizó un análisis de regresión logística multivariante. Para cada paciente se calculó el EEH, los reingresos prematuros y el coste asociado al EEH. Para todos los análisis se utilizó un dintel de significación estadística de 0,05 y se realizaron con el paquete estadístico SPSS v15.0. Resultados: se incluyeron 310 pacientes, de los cuales el 54,2% fueron mujeres, la edad media fue de 80,1 años (DE: 6,8), con un rango entre 65 y 95 años. En cuanto al diagnóstico al ingreso, el 27,4% correspondían a enfermedades del aparato respiratorio, 22,6% del circulatorio y 11,6% del digestivo. La mediana del Índice de Charlson fue de 2,0, encontrando que el 36,8% de los pacientes presentaban una comorbilidad alta. Las patologías crónicas más prevalentes fueron la diabetes mellitus (44,2%), la enfermedad renal crónica (25,2%) y la demencia (10,6). En relación con el CONUT, el 75,8% de los pacientes presentaban criterios de desnutrición: el 42,6% leve, el 28,7% moderada y el 4,5% grave, de estos, solo un 46,6% tuvo algún tipo de soporte nutricional durante el ingreso. Los factores asociados a la presencia de desnutrición moderada-grave fueron el sexo femenino (OR: 1,7; IC 95%: 1,1 ­ 2,8), edad mayor de 80 años (OR: 2,0, IC 95%: 1,2 ­ 3,5), y la demencia (OR: 2,4; IC 95%:1,2 ­ 5,2). No se encontró asociación con la comorbilidad ni con otras patologías crónicas. Respecto al EEH (días), se encontraron diferencias entre los pacientes con desnutrición moderada-grave (4,7; IC 95%: 2,3 ­ 7,1) y normonutridos (-0,1; IC 95%: -1,4 ­ 1,2) (p = 0,001), no siendo así para los casos de desnutrición leve (1,6; IC 95%: 0,5-2,8) (p = 0,07). En relación a la tasa de reingresos prematuros en pacientes desnutridos fue de 28/235 (11,9%). El coste asociado al EEH/100 pacientes fue de 195.479,4 € para la desnutrición grave-moderada, 73.484,8 € desnutrición leve, mientras que en los pacientes normonutridos supuso un ahorro de 12.353 €. Conclusiones: la desnutrición hospitalaria en el paciente anciano sigue siendo un problema sin resolver, dada la elevada prevalencia encontrada, asociándose a un exceso de estancia hospitalaria y a un aumento del gasto hospitalario, especialmente en pacientes con desnutrición moderada- severa. El CONUT es una herramienta de cribado nutricional de gran utilidad por la rapidez y validez de sus resultados, y permite detectar pacientes con riesgo o alerta nutricional, sin suponer un incremento de costes.

Desnutrición en el paciente anciano al ingreso hospitalario, un viejo problema sin solucionar / Malnutrition in the elderly patient to hospital admission, an old problem unsolved

Objetivo: determinar la prevalencia de desnutrición en pacientes con edad igual o superior a 65 años al ingreso hospitalario y los factores asociados a su presencia. Analizar el exceso de estancia hospitalaria (EEH), el impacto económico y la tasa de reingresos prematuros asociados a la desnutrición hospitalaria en pacientes de edad avanzada. Material y métodos: estudio retrospectivo realizado en el Hospital Universitario Reina Sofía. Se incluyeron todos los pacientes con edad igual o mayor a 65 años que ingresaron en Medicina Interna durante 2011. Se calculó el tamaño muestral teniendo en cuenta los ingresos del año anterior, y considerando una prevalencia de desnutrición del 50% con un IC 95% y un error del 5%. Para definir el grado de desnutrición se empleó la herramienta Control Nutricional (CONUT), que establece una puntuación basada en la determinación de albúmina, colesterol total y linfocitos. Para determinar los factores asociados a la presencia de desnutrición moderada-grave se realizó un análisis de regresión logística multivariante. Para cada paciente se calculó el EEH, los reingresos prematuros y el coste asociado al EEH. Para todos los análisis se utilizó un dintel de significación estadística de 0,05 y se realizaron con el paquete estadístico SPSS v15.0. Resultados: se incluyeron 310 pacientes, de los cuales el 54,2% fueron mujeres, la edad media fue de 80,1 años (DE: 6,8), con un rango entre 65 y 95 años. En cuanto al diagnóstico al ingreso, el 27,4% correspondían a enfermedades del aparato respiratorio, 22,6% del circulatorio y 11,6% del digestivo. La mediana del Índice de Charlson fue de 2,0, encontrando que el 36,8% de los pacientes presentaban una comorbilidad alta. Las patologías crónicas más prevalentes fueron la diabetes mellitus (44,2%), la enfermedad renal crónica (25,2%) y la demencia (10,6). En relación con el CONUT, el 75,8% de los pacientes presentaban criterios de desnutrición: el 42,6% leve, el 28,7% moderada y el 4,5% grave, de estos, solo un 46,6% tuvo algún tipo de soporte nutricional durante el ingreso. Los factores asociados a la presencia de desnutrición moderada-grave fueron el sexo femenino (OR: 1,7; IC 95%: 1,1 - 2,8), edad mayor de 80 años (OR: 2,0, IC 95%: 1,2 - 3,5), y la demencia (OR: 2,4; IC 95%:1,2 - 5,2). No se encontró asociación con la comorbilidad ni con otras patologías crónicas. Respecto al EEH (días), se encontraron diferencias entre los pacientes con desnutrición moderada-grave (4,7; IC 95%: 2,3 - 7,1) y normonutridos (-0,1; IC 95%: -1,4 - 1,2) (p = 0,001), no siendo así para los casos de desnutrición leve (1,6; IC 95%: 0,5-2,8) (p = 0,07). En relación a la tasa de reingresos prematuros en pacientes desnutridos fue de 28/235 (11,9%). El coste asociado al EEH/100 pacientes fue de 195.479,4 Euros para la desnutrición grave-moderada, 73.484,8 Euros desnutrición leve, mientras que en los pacientes normonutridos supuso un ahorro de 12.353 Euros. Conclusiones: la desnutrición hospitalaria en el paciente anciano sigue siendo un problema sin resolver, dada la elevada prevalencia encontrada, asociándose a un exceso de estancia hospitalaria y a un aumento del gasto hospitalario, especialmente en pacientes con desnutrición moderada-severa. El CONUT es una herramienta de cribado nutricional de gran utilidad por la rapidez y validez de sus resultados, y permite detectar pacientes con riesgo o alerta nutricional, sin suponer un incremento de costes (AU)

Objetive: to determine the prevalence of malnutrition in patients aged 65 years or more at admission and factors associated with its presence. Analyze excess hospital stay (EHS), economic impact and premature readmission rate associated with hospital malnutrition in elderly patient. Material and method: retrospective study conducted at the University Hospital Reina Sofía. All patients aged 65 years or older admitted to internal medicine in 2011. The sample size was calculated taking into account the income of the previous year, and considering a prevalence of malnutrition of 50% with a 95% and included error of 5%. To define the degree of malnutrition nutritional control tool (CONUT), which establishes a score based on albumin, total cholesterol and lymphocyte determination was used. To determine the factors associated with the presence of moderate to severe malnutrition analysis of multivariate logistic regression was performed. For each patient the EHS, premature readmissions and the associated cost to EHS was calculated. A threshold of statistical significance of 0.05 was used for all analyzes and were performed with SPSS v15.0. Results: 310 patients, of whom 54.2% were women were included, the mean age was 80.1 years (SD: 6.8), ranging between 65 and 95 years. Regarding diagnosis at admission 27.4% were respiratory diseases, 22.6% of the circulatory and digestive 11.6%. The median Charlson index was 2.0, found that 36.8% of patients had high comorbidity. The most prevalent chronic diseases were diabetes mellitus (44.2%), chronic kidney disease (25.2%) and dementia (10.6). Regarding the CONUT, 75.8% of patients met the criteria of malnutrition: 42.6% mild, 28.7% moderate and severe 4.5%, of which only 46.6% had some nutritional support during admission. Factors associated with the presence of moderate to severe malnutrition were female gender (OR: 1.7; 95%: 1.1 - 2.8), age over 80 years (OR: 2.0, IC 95%: 1.2 - 3.5), and dementia (OR: 2.4; IC 95%:1.2 - 5.2). No association with comorbidity or with other chronic diseases was found. Regarding the EHS (days) differences between patients with moderate to severe malnutrition (4.7; IC 95%: 2.3 - 7.1) and normally nourished (-0.1; IC 95%: -1.4 - 1.2) (p = 0.001) were found, but were not for cases of mild malnutrition (1.6, 95%: 0.5-2.8) (p = 0.07).Regarding the rate of premature readmission in malnourished patients was 28/235 (11.9%). The cost associated with EHS / 100 patients was Euros 195 479.4 for moderate malnutrition, mild malnutrition Euros 73 484.8, and normally nourished patients represented a saving of Euros 12 353. Conclusions: hospital malnutrition in elderly patients remains an unsolved problem, given the high prevalence found, associated to an excess of hospital stay and increased hospital costs, especially in patients with moderate to severe malnutrition. The CONUT is a nutritional screening tool very useful for the speed and validity of their results, and allows detecting patients at risk or nutritional alert without lead to increased costs (AU)

[Follow-up of analytical parameters in Internal Medicine patients to detect adverse events]. / Seguimiento de parámetros analíticos en pacientes de medicina.

OBJECTIVE: To analyze the prevalence of prescription drugs, previously selected, that should be monitored by their analytical test, and the rate of alteration in these tests, with the aim of establishing priorities to facilitate monitoring. METHOD: Prospective observational study in the Internal Medicine department of a referral hospital of 350 beds. In a first phase, we selected some drugs which analytical monitoring is recommended for the medical literature, and after that, we reviewed the pharmacological treatment of all patients admitted with any of these drugs. The study was conducted in the last two month of 2011. RESULTS: We included 271 patients, 128 (47%) were women. The mean age was 74.5 ± 14.4 years and the average stay of 7 ± 5.8 days. These patients accounted for 83% of all patients admitted to Internal Medicine during the study period. There were 828 drugs that must be monitored; each patient had an average of 3.1 ± 2.3. We reviewed 1837 analytical test, of which 401 (22%) were altered and 154 patients (57%) were affected for it. The pairs drug-analytical test altered most frequently found were creatinine increased and nephrotoxic drugs, hypokalemia in patients taking high efficiency diuretics and thrombocytopenia in patients treated with low molecular weight heparins. CONCLUSIONS: Our study highlights the importance of monitoring laboratory test associated with some drugs from the pharmacy department, as it demonstrates a high incidence of warning results. Our proposal for selection of drugs makes monitoring easier, and reaches large numbers of patients.

Seguimiento de parámetros analíticos en pacientes de medicina interna para detectar efectos adversos / Follow-up of analytical parameters in Internal Medicine patients to detect adverse events

Objetivo: Determinar la frecuencia con la que se prescriben una serie de fármacos, previamente seleccionados, sobre los que existen recomendaciones de monitorización mediante parámetros analíticos, y la prevalencia de analíticas alteradas con el fin de establecer prioridades para facilitar su seguimiento. Método: Estudio prospectivo observacional realizado en el servicio de Medicina Interna de un hospital de referencia de área de 350 camas. En una primera fase se realizó una selección de fármacos cuya monitorización analítica está recomendada en la bibliografía, y posteriormente se realizó un seguimiento de los pacientes ingresados con alguno de estos fármacos en su tratamiento. El estudio se llevó a cabo en el último bimestre de 2011. Resultados: Se incluyeron 271 pacientes, de los cuales 128 (47%) fueron mujeres. La edad media fue de 74,5±14,4 años y la estancia media de 7±5,8 días. Estos pacientes representaron el 83% de todos los pacientes ingresados en el servicio de Medicina Interna durante el periodo de estudio. Se registraron 828 medicamentos susceptibles de monitorización; cada paciente tuvo una media de 3,1±2,3. Se revisaron 1837 analíticas, de las cuales 401 (22%) estaban alteradas y afectaron a 154 pacientes (57%). Los binomios fármaco-parámetro analítico alterado más frecuentemente encontrados fueron incremento de creatinina-fármacos nefrotóxicos, hipopotasemia en pacientes tratados con diuréticos de alta eficacia y trombocitopenia en pacientes tratados con heparinas de bajo peso molecular. Conclusiones: En nuestro estudio se pone de manifiesto la importancia de vigilar desde el servicio de Farmacia ciertos parámetros analíticos relacionados con determinados fármacos, ya que se demuestra una elevada incidencia de resultados alertantes. Nuestra propuesta de selección de fármacos facilita el seguimiento y alcanza a gran cantidad de pacientes (AU)

Objective: To analyze the prevalence of prescription drugs, previously selected, that should be monitored by their analytical test, and the rate of alteration in these tests, with the aim of establishing priorities to facilitate monitoring. Method: Prospective observational study in the Internal Medicine department of a referral hospital of 350 beds. In a first phase, we selected some drugs which analytical monitoring is recommended for the medical literature, and after that, we reviewed the pharmacological treatment of all patients admitted with any of these drugs. The study was conducted in the last two month of 2011. Results: We included 271 patients, 128 (47%) were women. The mean age was 74.5 ± 14.4 years and the average stay of 7 ± 5.8 days. These patients accounted for 83% of all patients admitted to Internal Medicine during the study period. There were 828 drugs that must be monitored; each patient had an average of 3.1 ± 2.3. We reviewed 1837 analytical test, of which 401 (22%) were altered and 154 patients (57%) were affected for it. The pairs drug-analytical test altered most frequently found were creatinine increased and nephrotoxic drugs, hypokalemia in patients taking high efficiency diuretics and thrombocytopenia in patients treated with low molecular weight heparins. Conclusions: Our study highlights the importance of monitoring laboratory test associated with some drugs from the pharmacy department, as it demonstrates a high incidence of warning results. Our proposal for selection of drugs makes monitoring easier, and reaches large numbers of patients (AU)