Effectiveness and safety of a 6-month treatment with paricalcitol in patients on hemodialysis with secondary hyperparathyroidism.

Introduction: The mineral bone disorder, particularly secondary hyperparathyroidism, in chronic kidney disease (CKD) has a systemic impact affecting not only bone metabolism. Therefore its correction is important to prevent cardiovascular, inflammatory and immune diseases. Objective: To assess the effectiveness and safety of intravenous paricalcitol administered over a 6 month period for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing conventional hemodialysis, with close follow-up of treatment response. Methods: A phase 4 clinical trial was performed comparing clinical and laboratory data before and after 6 months of treatment. SHPT patients undergoing hemodialysis who were naïve to vitamin D metabolites or had failed to current therapy were included. Clinical and laboratory characteristics were analyzed. Efficacy analyses were based on intact parathyroid hormone (iPTH) levels and were performed using data from patients who completed 6 months of treatment. Results: Nineteen of the 26 patients enrolled completed 6 months of treatment. All patients exhibited reduced baseline iPTH levels (mean reduction, 371.8 pg/mL; 95% CI, 273.3-470.2 pg/mL]; 17 patients (89.5%) had reductions exceeding 30%. Twelve patients (63%) achieved therapeutic success (defined as iPTH serum levels 150-300 pg/mL), with a median time of 2 months from the beginning of treatment. All reported episodes of hypercalcemia (n = 2) and hyperphosphatemia (n = 34) were asymptomatic. No major therapy-related serious AEs were reported. Conclusion: Paricalcitol was safely administered and was associated with significant decreases in iPTH levels over the study period.

Introdução: A doença metabólica óssea, em particular o hiperparatireoidismo secundário, na doença renal crônica (DRC) tem um impacto sistêmico que afeta nem só o metabolismo ósseo. Por tanto, sua correção é importante para prevenir as doenças do sistema imunitário, inflamatório e cardiovascular. Objetivo: Avaliar a eficácia e a segurança do paricalcitol intravenoso administrado durante um período de 6 meses no tratamento do hiperparatireoidismo secundário (SHPT) em pacientes submetidos a hemodiálise convencional, com acompanhamento de perto da resposta do tratamento. Métodos: Realizou-se um ensaio clínico de fase 4 que comparava os dados clínicos com os dados do laboratório antes e depois dos 6 meses de tratamento. Incluíram-se os pacientes SHPT em hemodiálise sem experiência com os metabólitos da vitamina D ou que fracassaram com a terapia em uso. Analisaram-se as características clínicas e de laboratório. As análises de eficácia se basearam nos níveis do hormônio da paratireóide intacto (iPTH) e foram realizadas usando dados dos pacientes que completaram os 6 meses de tratamento. Resultados: Dezenove dos 26 pacientes registrados completaram os 6 meses de tratamento. Todos os pacientes mostraram níveis de referência iPTH reduzidos (redução média, 371,8 pg/mL; 95% CI, 273,3-470.2 pg/mL]; 17 pacientes (89,5%) tiveram reduções superiores a 30%. Doze pacientes (63%) conseguiram o sucesso terapêutico (definido como níveis de soros iPTH de 150-300 pg/mL), com um tempo médio de 2 meses a partir do início do tratamento. Todos os episódios de hipercalcemia (n = 2) e de hiperfosfatemia (n = 34) reportados foram assintomáticos. Não se informaram AEs graves importantes relacionados à terapia. Conclusão: O paricalcitol foi administrado de forma segura e se associou às reduções significativas nos níveis de iPTH durante o período do estudo.

Effectiveness and safety of a 6-month treatment with paricalcitol in patients on hemodialysis with secondary hyperparathyroidism / Eficácia e segurança do tratamento de 6 meses com paricalcitol em pacientes em hemodiálise com hiperparatiroidismo secundário

Abstract Introduction: The mineral bone disorder, particularly secondary hyperparathyroidism, in chronic kidney disease (CKD) has a systemic impact affecting not only bone metabolism. Therefore its correction is important to prevent cardiovascular, inflammatory and immune diseases. Objective To assess the effectiveness and safety of intravenous paricalcitol administered over a 6 month period for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing conventional hemodialysis, with close follow-up of treatment response. Methods: A phase 4 clinical trial was performed comparing clinical and laboratory data before and after 6 months of treatment. SHPT patients undergoing hemodialysis who were naïve to vitamin D metabolites or had failed to current therapy were included. Clinical and laboratory characteristics were analyzed. Efficacy analyses were based on intact parathyroid hormone (iPTH) levels and were performed using data from patients who completed 6 months of treatment. Results: Nineteen of the 26 patients enrolled completed 6 months of treatment. All patients exhibited reduced baseline iPTH levels (mean reduction, 371.8 pg/mL; 95% CI, 273.3-470.2 pg/mL]; 17 patients (89.5%) had reductions exceeding 30%. Twelve patients (63%) achieved therapeutic success (defined as iPTH serum levels 150-300 pg/mL), with a median time of 2 months from the beginning of treatment. All reported episodes of hypercalcemia (n = 2) and hyperphosphatemia (n = 34) were asymptomatic. No major therapy-related serious AEs were reported. Conclusion: Paricalcitol was safely administered and was associated with significant decreases in iPTH levels over the study period.

Resumo Introdução: A doença metabólica óssea, em particular o hiperparatireoidismo secundário, na doença renal crônica (DRC) tem um impacto sistêmico que afeta nem só o metabolismo ósseo. Por tanto, sua correção é importante para prevenir as doenças do sistema imunitário, inflamatório e cardiovascular. Objetivo: Avaliar a eficácia e a segurança do paricalcitol intravenoso administrado durante um período de 6 meses no tratamento do hiperparatireoidismo secundário (SHPT) em pacientes submetidos a hemodiálise convencional, com acompanhamento de perto da resposta do tratamento. Métodos: Realizou-se um ensaio clínico de fase 4 que comparava os dados clínicos com os dados do laboratório antes e depois dos 6 meses de tratamento. Incluíram-se os pacientes SHPT em hemodiálise sem experiência com os metabólitos da vitamina D ou que fracassaram com a terapia em uso. Analisaram-se as características clínicas e de laboratório. As análises de eficácia se basearam nos níveis do hormônio da paratireóide intacto (iPTH) e foram realizadas usando dados dos pacientes que completaram os 6 meses de tratamento. Resultados: Dezenove dos 26 pacientes registrados completaram os 6 meses de tratamento. Todos os pacientes mostraram níveis de referência iPTH reduzidos (redução média, 371,8 pg/mL; 95% CI, 273,3-470.2 pg/mL]; 17 pacientes (89,5%) tiveram reduções superiores a 30%. Doze pacientes (63%) conseguiram o sucesso terapêutico (definido como níveis de soros iPTH de 150-300 pg/mL), com um tempo médio de 2 meses a partir do início do tratamento. Todos os episódios de hipercalcemia (n = 2) e de hiperfosfatemia (n = 34) reportados foram assintomáticos. Não se informaram AEs graves importantes relacionados à terapia. Conclusão: O paricalcitol foi administrado de forma segura e se associou às reduções significativas nos níveis de iPTH durante o período do estudo.

The First Report of The Latin American Society of Nephrology and Hypertension (SLANH) Anemia Committee in Chronic Hemodialysis Patients

Background: Anemia almost invariably occurs in patients with chronic kidney disease. Limited data are available regarding anemia management in Latin American (LA) hemodialysis (HD) patients. Objective: To evaluate the results of the first anemia survey of the Anemia Committee of the SLANH. Methods: This is a multinational, voluntary survey that collected anemia management data from adult HD patients from independent, non-chain owned HD units, between 09/2009 and 03/2010. T-test, ANOVA, chi-square test and multivariate logistic regression were used for statistical analysis. Results: The survey received responses from 134 HD units of 16 countries providing data from 9,025 patients. Mean values of Hb, ferritin, and transferrin saturation (TSAT) were 10.5±1.8g/dL, 570±539μg/l, and 29.8±15%, respectively. Only 32.7% of patients were within the Hb target of 10.5-12.0g/dL (46.3% were below and 21.1% above). Erythropoietin-stimulating agents (ESAs) were administered to 84.3% patients and 68.3% received intravenous iron (IV). Iron deficiency (TSAT≤20%) was present in 27.5% patients and among those receiving erythropoietin, 47% did not achieve Hb target. The independent variables associated with the lowest Hb level (<10.5g/dL) were: female gender, TSAT<25% and age<50 years. Conclusions: According to these results, nearly half of LA chronic HD patients did not achieve the recommended Hb target despite wide use of ESAs and IV iron (AU)

Antecedentes: La anemia representa una complicación frecuente en pacientes con enfermedad renal crónica. En Latinoamérica (LA) la prevalencia y características de la anemia en pacientes en hemodiálisis (HD) no ha sido bien estudiada. Objetivo: Evaluar los resultados del primer registro de anemia del Comité de Anemia de la Sociedad Latinoamericana de Nefrología e Hipertensión. Métodos: Esta es una encuesta multinacional, voluntaria, que recolectó datos sobre el tratamiento de la anemia en pacientes en HD de unidades independientes en LA entre septiembre de 2009 y marzo de 2010. Para el análisis estadístico se utilizaron los siguientes métodos: t-test, ANOVA, χ2 y el análisis de regresión logística multivariante. Resultados: La encuesta fue respondida por 134 unidades de HD de 16 países, recibiéndose datos de 9025 pacientes. Las medias ± desviación estándar de Hb, ferritina y del índice de saturación de transferrina (IST) fueron respectivamente: 10,5 ± 1,8 g/dl, 570 ± 539 μg/l y 29,8 % ± 15. Se administró agentes estimulantes de la eritropoyesis (AEE) al 84,3 % de los pacientes y hierro intravenoso (FeIV) al 68,3 %. Solamente el 32,7 % de los pacientes tuvieron una Hb blanco de 10,5-12,0 g/dl. En pacientes con Hb < 10,5 g/dl, el 85,2 % estaban recibiendo AEE y un 68 % FeIV. Las variables independientes asociadas con nivel Hb < 10,5 g/dl fueron: género femenino, IST < 25 % y edad < 50 años. En la muestra de pacientes analizada, a pesar del amplio uso de los AEE y FeIV, casi la mitad de los pacientes no alcanzó la Hb blanco (AU)

The first report of The Latin American Society of Nephrology and Hypertension (SLANH) Anemia Committee in chronic hemodialysis patients.

BACKGROUND: Anemia almost invariably occurs in patients with chronic kidney disease. Limited data are available regarding anemia management in Latin American (LA) hemodialysis (HD) patients. OBJECTIVE: To evaluate the results of the first anemia survey of the Anemia Committee of the SLANH. METHODS: This is a multinational, voluntary survey that collected anemia management data from adult HD patients from independent, non-chain owned HD units, between 09/2009 and 03/2010. T-test, ANOVA, chi-square test and multivariate logistic regression were used for statistical analysis. RESULTS: The survey received responses from 134 HD units of 16 countries providing data from 9,025 patients. Mean values of Hb, ferritin, and transferrin saturation (TSAT) were 10.5 ± 1.8 g/dL, 570 ± 539 µg/l, and 29.8 ± 15%, respectively. Only 32.7% of patients were within the Hb target of 10.5-12.0 g/dL (46.3% were below and 21.1% above). Erythropoietin-stimulating agents (ESAs) were administered to 84.3% patients and 68.3% received intravenous iron (IV). Iron deficiency (TSAT≤20%) was present in 27.5% patients and among those receiving erythropoietin, 47% did not achieve Hb target. The independent variables associated with the lowest Hb level (<10.5 g/dL) were: female gender, TSAT<25% and age<50 years. CONCLUSIONS: According to these results, nearly half of LA chronic HD patients did not achieve the recommended Hb target despite wide use of ESAs and IV iron.

Consulta muy tardía por insuficiencia renal crónica: riesgo muy alto para los pacientes y costo muy elevado para las instituciones de asistencia / Late medical consultation for chronic renal failure: high risk for patients and high cost for health centers

Los pacientes que ingresan a di lisis crónica (DC) tardíamente son una población de alto riesgo, particularmente aquellos que deben iniciar de urgencia el tratamiento dialítico. Desde 1981, m s de 50 por ciento de los pacientes que ingresaron a DC en Uruguay lo hicieron sin preparación previa. El objetivo de este estudio es investigar el número de pacientes que consultaron muy tardíamente entre los incidentes con insuficiencia renal crónica extrema (IRCE), así como la morbimortalidad (MM) y costos asociados a esa condición, en una subpoblación de Uruguay durante 2003. Se incluyeron prospectivamente todos los pacientes incidentes con IRCE. Se identificaron 81 pacientes. Cincuenta y seis pacientes (69,1 por ciento) consultaron muy tardíamente, requirieron 1.120 días de internación (20 días/paciente) y 578 sesiones de hemodi lisis (HD) en servicios de pacientes agudos (10,3 HD/paciente). En este grupo fallecieron cinco pacientes antes de ingresar a DC y nueve pacientes en los seis meses siguientes al ingreso a DC. Veinticinco pacientes (30,9 por ciento), ingresaron coordinados, requirieron 73 días de internación (2,9 días/paciente) en el período de ingreso y ninguno falleció en los primeros seis meses de tratamiento con DC. Los costos por hospitalización en el período de ingreso fueron 4.800 dólares por paciente de consulta muy tardía y 140 dólares por paciente de ingreso coordinado. En conclusión, durante 2003 en la población estudiada la mayoría de los pacientes incidentes con IRCE requirieron HD de urgencia al inicio del tratamiento dialítico. Los días de hospitalización, la MM y los costos de tratamiento fueron muy elevados en relación con los pacientes que ingresaron coordinados.

Evolution of serum phosphate in long intermittent hemodialysis.

BACKGROUND: Phosphate (P) control is crucial to prevent secondary hyperparathyroidism and extraosseous calcification. Hemodialysis techniques normally used do not remove the amount of P absorbed from an adequate protein intake. Our long hemodialysis (LHD) procedure produces greater P removal in a seven-hour session than in a conventional four-hour session. Our aim was to assess the evolution of predialysis serum P and Ca x P product in patients on intermittent LHD during the first two years on this dialysis schedule. METHODS: Eight irregular compliant patients underwent LHD for 12 months; five of them completing 24 months. In the conventional hemodialysis (CHD) period, session time was 12 hours per week, while it was 21 hours per week in LHD. We compared P and Ca x P product throughout both periods; each patient was his or her own control. RESULTS: Mean serum P improved from 7.1 +/- 1.1 mg/dL in CHD to 5.6 +/- 1.1 mg/dL during the second year on LHD (P < 0.05). Mean Ca x P product decreased from 64 +/- 12.7 mg2/dL2 during CHD to 50.9 +/- 10.3 mg2/dL2 at the end of the second year of LHD. CONCLUSION: By prolonging dialysis time to 21 hours per week, better P serum control and lower Ca x P product were achieved in our patients.