C.E.R.A. safety profile: a pooled analysis in patients with chronic kidney disease.

BACKGROUND: C.E.R.A., a continuous erythropoietin receptor activator, is a long-acting erythropoiesis-stimulating agent (ESA) that is approved for the treatment of renal anemia. This analysis evaluated the safety profile of C.E.R.A. in comparison to that of other ESAs in patients with chronic kidney disease (CKD). METHODS: Safety parameters were analyzed in a pooled population comprising all patients with CKD on dialysis and not on dialysis from the completed Phase II and Phase III studies in the C.E.R.A. clinical program (Phase II/III population); patients were treated with either C.E.R.A. (n = 1,789) or comparator ESA (n = 948). Differences between treatment groups in safety parameters were identified by either a 2% difference in incidence between groups, or a statistically significant difference between groups (p < or = 0.05 with the Fisher's exact test, which was used as a conservative screening tool). To assess changes in safety findings over time, long-term safety data were analyzed from patients who were given the option to enter long-term safety studies upon completing their initial Phase II/III study (safety extension population). RESULTS: Compared with the C.E.R.A. group, the incidence of adverse events (AEs) was higher in the comparator ESA group in the Phase II/III population (C.E.R.A. vs. comparator ESA, 89.5% vs. 91.8%, p = 0.067), and significantly so in the safety extension population (93.0% vs. 95.8%, p = 0.003). The incidence of serious AEs was significantly higher in the comparator ESA group than in the C.E.R.A. group in both analysis populations (Phase II/III population, 37.8% vs. 42.4%, p = 0.021; safety extension population, 53.3% vs. 59.7%, p = 0.001). However, there was no consistent pattern of clinical events that could explain these differences between the treatment groups. CONCLUSION: Analysis of safety events in patients with renal anemia receiving long-term treatment with C.E.R.A. shows a safety profile comparable to that of other ESAs.

Situación clínica del paciente en el momento de iniciar diálisis. Estudio INESIR / Clinical status of the patient at the time of dialysis onset: INESIR study

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Calidad de vida en los pacientes con insuficiencia renal crónica. Influencia de la intervención precoz del nefrólogo y de la consulta prediálisis / Quailty of life in patients with chronic renal failure. Influence of nephrologist´s early intervention and pre-dialysis clinical visit consultation

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Eficiencia de implantar en atención primaria un programa dirigido a conseguir la referencia precoz al nefrólogo de los pacientes con insuficiencia renal crónica / Efficiency of implementing a program aimed at achieving early referral to the nephrologist of patients with chronic renal failure in primary care

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Therapy of intractable pruritus with MARS.

INTRODUCTION: Pruritus is the most disabling symptom in patients with cholestatic liver diseases. Many drug therapies have been used for the treatment of these diseases, with different outcomes. The molecular adsorbent recirculating system (MARS) has been used in the treatment of intractable pruritus in cholestatic syndromes. We report our experience with MARS in 3 patients with intractable pruritus on the waiting list: 2 liver transplant recipients and a patient with primary biliary cirrhosis. PATIENTS AND RESULTS: Two middle-aged women and 1 middle-aged man, who were recipients of an orthotopic liver transplant for primary biliary cirrhosis, underwent three (n = 2) and two (n = 1) 6-hour sessions of MARS due to medically uncontrollable pruritus. All noted marked improvement of pruritus, with decreased bilirubin levels, but this improvement lasted only a few days in all cases. We observed no changes in transaminase or albumin levels, or prothrombin time. Complications included an episode of angina due to anemia caused by jugular catheter bleeding, and thrombocytopenia in all patients. CONCLUSIONS: MARS is an effective treatment for intractable pruritus in cholestatic liver diseases, although its beneficial effect is short. This extracorporeal liver device is safe, because most related adverse events are mild.

[Differences in health-related quality of life between male and female hemodialysis patients]. / Diferencias en la calidad de vida relacionada con la salud entre hombres y mujeres en tratamiento en hemodíalisis.

BACKGROUND: Previous studies in renal patients have reported that women perceive a lower health-related quality of life (HRQOL) than men: however, these studies have been carried out without taking into account the gender-related differences shown in general population samples. The aims of the present study are: a) to define the HRQOL dimensions in which there are differences between men and women on chronic hemodialysis (HD), correcting then the differences on the generic dimensions by means of standardization by age and gender of the obtained scores, using Spanish normative data, and b) to identify the variables that cause these possible gender-related differences on HRQOL. METHODS: A cross-sectional multi-center study was carried out with 152 patients (69 men and 83 women) receiving HD treatment in 43 Spanish centers, using the KDQOL-SF to evaluate their HRQOL. The generic KDQOL-SF scores were standardized by age and gender using Spanish normative data. Sociodemographic, clinical and psychosocial variables were also collected on each patient. A MANOVA was carried out to study the variables associated with the gender-related differences on HRQOL. The sociodemographic, clinical and psychosocial variables showing significant differences between men and women in the previous univariate analysis were entered as covariates. RESULTS: The KDQOL-SF scores showed statistically significant differences between men and women in four scales: physical functioning, emotional role limitation, social function and emotional well-being. In contrast, standardized scores showed no differences between men and women in the profile or degree of HRQOL impairment. Although statistically significant gender-related differences were shown in educational level, employment, haemoglobin, Kt/V, trait anxiety and depressive symptoms, only the last two variables showed an independent effect on the differences in HRQOL. CONCLUSION: Impaired HRQOL in women on HD reflects the gender-related differences that are also shown in the general population, and they are related to the higher prevalence of trait anxiety and depressive symptoms in women.

The influence of hepatitis B and hepatitis C virus infection in the recipient on late renal allograft failure.

BACKGROUND: Chronic liver disease is one of the most important complications after renal transplantation. Hepatitis B and mainly hepatitis C are the more frequent causes of liver disease. Although there are controversial results, in some series, hepatitis B and hepatitis C are associated with lower graft and patient survival. PATIENTS AND METHODS: A total of 3365 adult patients who received a renal transplant in 1990 (N = 824), 1994 (N = 1075) and 1998 (N = 1466) with a functioning graft after the first year were included. Fifty-one (2.1%) with positive HbsAg were diagnosed with hepatitis B at transplantation; 488 (16.9%) presented positive anti-hepatitis C antibodies and were diagnosed with hepatitis C virus (HCV) infection and 25 patients (0.8%) were diagnosed with concomitant hepatitis B virus (HBV) and HVC infection. Demographic, immunosuppression, survival figures and post-transplant and follow-up data of these patients and negative HBV and HVC patients were recorded. RESULTS: The overall prevalence of HBV in the recipients was 2.1%. Patient survival was lower and liver disease was the main cause of death in HBV-positive patients. However, in the multivariate analysis the presence of positive HbsAg did not have an independent risk factor for graft loss and patient death. This finding was similar in patients with concomitant HBV and HVC infection. Graft and patient survival were lower in HCV-positive patients and liver disease was the main cause of death. Interestingly, proteinuria and serum creatinine were risk factors for graft loss and patient death. Fortunately, prevalence of HCV in the recipients significantly decreased from 29% in 1990 to 10% in 1998. CONCLUSIONS: In the last decade in Spain, HBV infection in the recipients, showing an overall prevalence approximately 2%, did not influence graft and patient survival. However, HCV infection in the recipient was associated with lower graft and patient survival, although the prevalence of HCV clearly decreased from 29% in 1990 to 10% in 1998.

Diferencias en la calidad de vida relacionada con la salud entre hombres y mujeres en tratamiento en hemodiálisis / Gender-differences in health-related quality of life in hemodialysis patients

Introducción: Estudios previos en pacientes en hemodiálisis (HD) muestran que las mujeres obtienen peores puntuaciones que los hombres en calidad de vida relacionada con la salud (CVRS), sin que se haya determinado si estas diferencias se deben al mayor impacto de la enfermedad renal y la HD en el sexo femenino o reflejan las diferencias entre sexos que también se presentan en población general. Los objetivos de este estudio son: a) definir el alcance de las diferencias en CVRS entre hombres y mujeres en HD, y b) identificar los factores que causan las diferencias. Métodos: Se evaluó la CVRS de 152 pacientes en tratamiento en HD utilizando el KDQOL-SF. En cada paciente se recogieron datos sociodemográficos, clínicos y psicosociales (ansiedad rasgo, síntomas depresivos y apoyo social). En las escalas genéricas del KDQOL-SF se llevó a cabo la estandarización de las puntuaciones por edad y sexo respecto a la norma poblacional. Se compararon las puntuaciones directas y estandarizadas de hombres y mujeres en el KDQOL-SF mediante ANOVAS. Los factores relacionados con las diferencias entre sexos en CVRS se estudiaron mediante MANOVA. Resultados: Las puntuaciones directas del KDQOL-SF indicaron diferencias estadísticamente significativas entre sexos en cuatro escalas genéricas: función física, rol emocional, función social y salud mental. En estas escalas no se encontraron diferencias en las puntuaciones estandarizadas para cada sexo. Aunque se presentaron diferencias significativas entre hombres y mujeres en el nivel de estudios, la situación laboral, las cifras de hemoglobina y Kt/V, la ansiedad rasgo y los síntomas depresivos, sólo estas dos últimas variables mostraron un efecto independiente en las diferencias en CVRS. Conclusiones: La peor CVRS que presentan las mujeres en HD es el reflejo de las diferencias entre sexos que también se presentan en la población general y se relacionan con la mayor prevalencia de la ansiedad rasgo y los síntomas depresivos en las mujeres (AU)

Pautas de detección, prevención y tratamiento de la nefropatía diabética en España / Guidelines of detection, prevention and treatment of diabetic nephropathy in Spain

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Los casos de muerte súbita tras la hemodiálisis: hechos, dudas y reflexiones / Sudden deaths in dialysis: facts, doubts and reflections

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Las guías clínicas nefrológicas en Atención Primaria / Nephrologic clinical guidelines in primary care

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