Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding.

Background: Patients with liver cirrhosis and gastrointestinal bleeding (GIB) often develop anemia. Ferric carboxymaltose (FCM) is an intravenous (i.v.) iron formulation approved for use in patients with iron deficiency with inadequate response to oral iron therapy or when oral iron cannot be used. Here we analyzed the efficacy and safety of FCM treatment in cirrhotic patients with anemia and GIB. Methods: Retrospective observational study of patients with cirrhosis and acute or chronic GIB treated with 1,000 mg FCM at the University Hospital Arnau de Vilanova (Lleida, Spain) that follows a restrictive-transfusion strategy. All data were obtained from the patients' medical records. We used the Wilcoxon test to evaluate statistical significance. Results: Patients with cirrhosis and GIB (n = 34) were treated with 1,000 mg FCM. Portal hypertension were present in 88.2% of the patients. For hospitalized patients (n = 21), median serum hemoglobin (s-Hb) levels increased by 3.0 g/dL (p < 0.02) and 3.9 g/dL (p < 0.07) for patients treated with FCM who had or had not received also a transfusion, respectively, compared to levels recorded upon admission. For outpatients (n = 13) the mean s-Hb levels was 9.8 ± 1.6 g/dL before FCM treatment and 11.3 ± 2.1 g/dL after treatment, demonstrating a mean increase of 1.5 g/dL (p < 0.001). No serious adverse reactions to FCM were observed. Conclusion: FCM administration achieved optimal s-Hb levels in most cirrhotic patients with acute or chronic GIB, suggesting that early FCM infusion improves and maintains optimal s-Hb levels in these patients and may be an appropriate first-line therapy to treat their anemia.

El tratamiento antiviral no mejora la ateromatosis subclínica en pacientes con hepatitis crónica por virus de la hepatitis C / Antiviral treatment does not improve subclinical atheromatosis in patients with chronic hepatitis caused by hepatitis C virus

Introducción: La infección crónica por el virus de la hepatitis C (VHC) es un factor de riesgo para desarrollar placas de ateroma, aunque se desconoce el posible efecto al eliminar el virus. Nuestro objetivo fue analizar si tras 12 meses de la erradicación del VHC por antivirales de acción directa (AAD) mejoraba la ateromatosis subclínica y existía modificación en la composición de las placas. Materiales y métodos: Estudio prospectivo que incluyó 85 pacientes con infección crónica por VHC en diferentes estadios de fibrosis, sometidos a AAD. Se excluyeron pacientes con antecedentes cardiovasculares, diabetes y enfermedad renal. Se realizó ecografía arterial (carótidas y femorales) para diagnosticar placa de ateroma (definida como grosor íntima-media≥1,5mm) y se analizó su composición (porcentaje de lípidos, fibrosis y calcio con software HEMODYN4) al inicio del estudio y tras 12 meses de finalizar la terapia. Resultados: Tras el seguimiento no se detectaron cambios en el grosor íntima-media (0,65mm vs. 0,63mm, p=0,240) ni en la presencia de placas (65,9%vs. 71,8%, p=0,063). Tampoco hubo modificación significativa en la composición de las mismas ni del territorio vascular afecto, observándose un aumento del perfil lipídico en sangre (p<0,001) tras 12 meses del tratamiento. Estos resultados se confirmaron en subgrupos por gravedad de enfermedad hepática. Discusión: La erradicación del VHC por AAD no mejora las placas de ateroma ni varía su composición, independientemente de la fibrosis hepática. Se precisan más estudios prospectivos que evalúen el riesgo residual cardiovascular tras la erradicación viral

Introduction: Chronic infection with hepatitis C virus is a risk factor for developing atheromatous plaques, although the possible effect of virus clearance is unknown. Our aim was to determine whether or not subclinical atheromatosis improved and there was any modification in the composition of the plaques 12 months after eradication of hepatitis C virus by direct-acting antiviral agents. Materials and methods: Prospective study that included 85 patients with chronic hepatitis C virus infection in different stages of fibrosis who were on direct-acting antiviral agents. Patients with a cardiovascular history, diabetes and kidney disease were excluded. An arterial ultrasound (carotid and femoral) was performed to diagnose atheromatous plaques (defined as intima-media thickness ≥1.5mm) and the composition (percentage of lipids, fibrosis and calcium with HEMODYN4 software) was analysed at the beginning of the study and 12 months after stopping the therapy. Results: After follow-up no changes were detected in the intima-media thickness (0.65mm vs. 0.63mm, P=.240) or in the presence of plaques (65.9% vs 71.8%, P=.063). There was also no significant change in their composition or affected vascular territory, with an increase in blood lipid profile (P<.001) after 12 months of treatment. These results were confirmed in subgroups by severity of liver disease. Discussion: The eradication of hepatitis C virus by direct-acting antiviral agents does not improve the atheroma plaques and nor does it vary their composition, regardless of liver fibrosis. More prospective studies are needed to evaluate residual cardiovascular risk after virus eradication

Antiviral treatment does not improve subclinical atheromatosis in patients with chronic hepatitis caused by hepatitis C virus. / El tratamiento antiviral no mejora la ateromatosis subclínica en pacientes con hepatitis crónica por virus de la hepatitis C.

INTRODUCTION: Chronic infection with hepatitis C virus is a risk factor for developing atheromatous plaques, although the possible effect of virus clearance is unknown. Our aim was to determine whether or not subclinical atheromatosis improved and there was any modification in the composition of the plaques 12 months after eradication of hepatitis C virus by direct-acting antiviral agents. MATERIALS AND METHODS: Prospective study that included 85 patients with chronic hepatitis C virus infection in different stages of fibrosis who were on direct-acting antiviral agents. Patients with a cardiovascular history, diabetes and kidney disease were excluded. An arterial ultrasound (carotid and femoral) was performed to diagnose atheromatous plaques (defined as intima-media thickness ≥1.5mm) and the composition (percentage of lipids, fibrosis and calcium with HEMODYN4 software) was analysed at the beginning of the study and 12 months after stopping the therapy. RESULTS: After follow-up no changes were detected in the intima-media thickness (0.65mm vs. 0.63mm, P=.240) or in the presence of plaques (65.9% vs 71.8%, P=.063). There was also no significant change in their composition or affected vascular territory, with an increase in blood lipid profile (P<.001) after 12 months of treatment. These results were confirmed in subgroups by severity of liver disease. DISCUSSION: The eradication of hepatitis C virus by direct-acting antiviral agents does not improve the atheroma plaques and nor does it vary their composition, regardless of liver fibrosis. More prospective studies are needed to evaluate residual cardiovascular risk after virus eradication.

Incidencia y factores predictivos de anemia ferropénica tras una hemorragia digestiva alta no asociada a hipertensión portal / Incidence and predictive factors of iron deficiency anemia after acute non-variceal upper gastrointestinal bleeding without portal hypertension

Introducción: Se desconoce la incidencia de anemia ferropénica (AF) tras un episodio de hemorragia digestiva no asociada a hipertensión portal (HDA). Objetivos: El objetivo principal fue estudiar la incidencia de AF tras una HDA, y los secundarios describir los factores predictivos de AF y elaborar modelos que permitan detectar aquellos pacientes que se beneficiarían de ferroterapia. Material y método: Desde abril de 2007 hasta mayo de 2009 se valoraron de forma prospectiva 391 pacientes con HDA. Se excluyeron todas las hemorragias secundarias a hipertensión portal y pacientes con condiciones clínicas y/o biológicas que pudieran artefactuar el patrón ferrocinético. Se practicó una analítica con parámetros férricos al ingreso, al 5.° y al 30.° día de la HDA. Se utilizó un modelo de regresión logística múltiple y un modelo de árboles de decisión. Resultados: De los 124 pacientes incluidos 76 (61,3%) presentaron AF a los 30 días de la HDA. Las variables predictoras de AF: edad > 75 años (p = 0,037; OR 3,9; IC 95%: 1,3-11,6), urea inicial > 80 mg/dl (p = 0,027; OR 2,9; IC 95%: 1,1-7,6), ferritina inicial ≤ 65 ng/dl (p = 0,002; OR 7,6; IC 95%: 2,9-18,5), Hb inicial ≤ 100 g/l (p = 0,003; OR 3,2; IC 95%: 1,3-8,0), Hb al 5.° día ≤ 100 g/l (p < 0,001; OR 14,9; IC 95%: 3,6-61,1) e índice de saturación de transferrina al 5.° día < 10% (p < 0,001; OR 7,2; IC 95%: 2,6-20,3). Conclusiones: La mayoría de pacientes con HDA presentan AF a los 30 días del episodio hemorrágico. La identificación de los factores predictivos de la misma permite establecer una indicación de ferroterapia tras la HDA (AU)

Introduction: There are few studies on iron deficiency anemia (IDA) after non-variceal acute upper gastrointestinal bleeding (UGIB) in patients without portal hypertension. Objectives: To define the incidence of IDA after UGIB, to characterize the predictive factors for IDA and to design algorithms that could help physicians identify those patients who could benefit from iron therapy. Material and method: We registered 391 patients with UGIB between April 2007 and May 2009. Patients with portal hypertension and those with clinical or/and biological conditions that could affect the ferrokinetic pattern were excluded. Blood analyses were performed, including ferric parameters upon admission, on the 5 th day, and on the 30th day after the hemorrhage episode. We used a multiple logistic regression model and a classification and regression tree model. Results: A total of 124 patients were included, of which 76 (61.3%) developed IDA 30 days after UGIB. The predictive variables were age > 75 years (P = .037; OR 3.9; 95% CI: 1.3-11.6), initial urea level > 80 mg/dL (P = .027; OR 2.9; 95% CI: 1.1-7.6), initial ferritin level ≤ 65 ng/dL (P = .002; OR 7.6; 95% CI: 2.9-18.5), initial hemoglobin level ≤ 100 g/L (P = .003; OR 3.2; 95% CI: 1.3-8.0), hemoglobin level on the 5 th day ≤ 100 g/L (P < .001; OR 14.9; 95% CI: 3.6-61.1) and the value of the transferrin saturation index on the 5 th day < 10% (p < 0.001; OR 7.2; 95% CI: 2.6-20.3). Conclusions: Most patients with UGIB developed IDA 30 days after the episode. Identification of the predictive factors for IDA may help to establish guidelines for the administration of iron therapy (AU)

[Incidence and predictive factors of iron deficiency anemia after acute non-variceal upper gastrointestinal bleeding without portal hypertension]. / Incidencia y factores predictivos de anemia ferropénica tras una hemorragia digestiva alta no asociada a hipertensión portal.

INTRODUCTION: There are few studies on iron deficiency anemia (IDA) after non-variceal acute upper gastrointestinal bleeding (UGIB) in patients without portal hypertension. OBJECTIVES: To define the incidence of IDA after UGIB, to characterize the predictive factors for IDA and to design algorithms that could help physicians identify those patients who could benefit from iron therapy. MATERIAL AND METHOD: We registered 391 patients with UGIB between April 2007 and May 2009. Patients with portal hypertension and those with clinical or/and biological conditions that could affect the ferrokinetic pattern were excluded. Blood analyses were performed, including ferric parameters upon admission, on the 5th day, and on the 30th day after the hemorrhage episode. We used a multiple logistic regression model and a classification and regression tree model. RESULTS: A total of 124 patients were included, of which 76 (61.3%) developed IDA 30 days after UGIB. The predictive variables were age >75 years (P=.037; OR 3.9; 95% CI: 1.3-11.6), initial urea level >80mg/dL (P=.027; OR 2.9; 95% CI: 1.1-7.6), initial ferritin level ≤65ng/dL (P=.002; OR 7.6; 95% CI: 2.9-18.5), initial hemoglobin level ≤100g/L (P=.003; OR 3.2; 95% CI: 1.3-8.0), hemoglobin level on the 5th day ≤100g/L (P<.001; OR 14.9; 95% CI: 3.6-61.1) and the value of the transferrin saturation index on the 5th day <10% (p<0.001; OR 7.2; 95% CI: 2.6-20.3). CONCLUSIONS: Most patients with UGIB developed IDA 30 days after the episode. Identification of the predictive factors for IDA may help to establish guidelines for the administration of iron therapy.

Hipertransaminasemia moderada en paciente asintomático tras realización de esfuerzo físico en gimnasio / Moderate hypertransaminasemia in an asymptomatic patient after physical exercise in a gymnasium

No disponible

[Early virologic response value as predictive factor of sustained virologic response to treatment with interferon alpha-2b plus ribavirin in chronic hepatitis C patients with or without HIV coinfection]. / Valor de la respuesta virológica precoz como factor predictivo de respuesta virológica sostenida al tratamiento con interferón alpha-2b y ribavirina en pacientes con hepatitis crónica C con o sin coinfección por el VIH.

BACKGROUND AND OBJECTIVE: The most effective currently available therapy for chronic hepatitis C virus infection is the combination of interferon alpha-2b plus ribavirin both, in patients with human immunodeficiency virus (HIV) coinfection and in patients without coinfection. In an attempt to avoid morbidity and health costs we searched for an indicator of early virologic response (EVR). We evaluated the EVR efficiency at 4 and 12-weeks after the initiation of antiviral combination therapy. PATIENTS AND METHOD: A total of consecutive 127 patients with chronic hepatitis C virus infection treated with combination therapy for 12 months in genotypes 1 and 4 and for 6 months in genotypes 2 and 3, were studied, 62 HIV-coinfected and 65 non-coinfected. They were evaluated for sustained virologic response and EVR at 4 and 12-weeks to initial therapy. RESULTS: Sustained virologic response was greater in the non-coinfected group than coinfected group; these differences were significant for genotypes 1 and 4. In both groups EVR had a 100% predictive negative value at 12-weeks after the initiation of therapy in genotypes 1 and 4, however came down in 79% at 4-weeks. CONCLUSIONS: The EVR at 12-weeks after the initiation of therapy has a 100% predictive negative value in coinfected and non-coinfected patients. Patient adherence to prescribed antiviral therapy is a predictive value of response.

Valor de la respuesta virologica precoz como factor predictivo de respuesta virologica sostenida al tratamiento con interferon alfa-2b y ribavirina en pacientes con hepatitis cronica C con o sin coinfeccion por el VIH / Early virologic response value as predictive factor of sustained virologic response to treatment with interferon alpha-2b plus ribavirin in chronic hepatitis C patients with or without HIV coinfection

Fundamento y objetivo: El tratamiento combinado de la hepatitis crónica por el virus de la hepatitis C con interferón alfa-2b más ribavirina es el más adecuado hoy día tanto en pacientes coinfectados con el virus de la inmunodeficiencia humana (VIH) como en los que no lo están. En un intento de evitar efectos secundarios a los pacientes y costes sanitarios al Estado, se está buscando indicadores de respuesta virológica precoz (RVP). En este estudio se pretende valorar la eficacia de la RVP a las 4 y 12 semanas del inicio del tratamiento combinado. Pacientes y método: Se ha estudiado a 127 pacientes consecutivos con hepatitis crónica por el virus C que recibieron tratamiento combinado durante 12 meses en los genotipos 1 y 4, y durante 6 meses en los genotipos 2 y 3. De ellos, 62 estaban coinfectados por el VIH y 65 no presentaban coinfección. Se valoraron la respuesta virológica sostenida al final del seguimiento y la RVP a las 4 y 12 semanas del inicio del tratamiento. Resultados: La respuesta virológica sostenida fue mayor en ambos grupos para los genotipos 2 y 3. En los genotipos 1 y 4 fue mayor en el grupo de los no coinfectados que en el de los coinfectados. La RVP tuvo un valor predictivo negativo del 100% en ambos grupos a las 12 semanas de tratamiento para los genotipos 1 y 4, y disminuyó a un 79% cuando se valoró a las 4 semanas. En los genotipos 2 y 3 no se observaron diferencias. Conclusiones: La RVP a las 12 semanas del inicio del tratamiento tiene un valor predictivo negativo del 100% tanto en coinfectados como en no coinfectados por el VIH. El cumplimiento del tratamiento es un valor predictivo de respuesta a éste

Background and objective: The most effective currently available therapy for chronic hepatitis C virus infection is the combination of interferon alpha-2b plus ribavirin both, in patients with human immunodeficiency virus (HIV) coinfection and in patients without coinfection. In an attempt to avoid morbidity and health costs we searched for an indicator of early virologic response (EVR). We evaluated the EVR efficiency at 4 and 12-weeks after the initiation of antiviral combination therapy. Patients and method: A total of consecutive 127 patients with chronic hepatitis C virus infection treated with combination therapy for 12 months in genotypes 1 and 4 and for 6 months in genotypes 2 and 3, were studied, 62 HIV-coinfected and 65 non-coinfected. They were evaluated for sustained virologic response and EVR at 4 and 12-weeks to initial therapy. Results: Sustained virologic response was greater in the non-coinfected group than coinfected group; these differences were significant for genotypes 1 and 4. In both groups EVR had a 100% predictive negative value at 12-weeks after the initiation of therapy in genotypes 1 and 4, however came down in 79% at 4-weeks. Conclusions: The EVR at 12-weeks after the initiation of therapy has a 100% predictive negative value in coinfected and non-coinfected patients. Patient adherence to prescribed antiviral therapy is a predictive value of response