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.

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.

Los pacientes que ingresan a diálisis crónica (DC) tardíamente son una población de alto riesgo, particularmente aquellos que deben iniciar de urgencia el tratamiento dialítico. Desde 1981, más de 50% 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%) consultaron muy tardíamente, requirieron 1.120 días de internación (20 días/paciente) y 578 sesiones de hemodiálisis (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%), 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.

Résumé Les patients qui entrent au service de dialyse chronique (DC) de façon tardive conforment une population à risque, surtout ceux qui doivent commencer le traitement dialytique d’urgence. Depuis 1981, plus de 50% des patients qui sont au DC en Uruguay n’avaient pas de préparation préalable. Le but de ce travail est d’analyser le nombre de patients qui ont consulté tardivement parmi les incidents à insuffisance rénale chronique extrème (IRCE), ainsi que la morbimortalité (MM) et les coûts associés à cette condi-tion, pour une population en Uruguay en 2003. On a identifié 81 patients. Cinquante-six patients (69,1%) ont consulté très tardivement, ont eu besoin de 1.120 jours d’hospitalisation (20 jours/patient ) et 578 sessions d’hémodialyse (HD) dans des services pour patients aigus (10,3 HD/patient). De ce groupe, cinq patients sont morts avant d’entrer au DC et neuf pendant les six mois postérieurs à leur entrée au DC. Vingt-cinq patients (30,9%) sont entrés avec coordination, ont demeuré 73 jours hospi-talisés (2,9 jours/patient) et aucun n’a décédé pendant les six premiers mois de traitement avec DC. Les coûts par hospitalisation ont été de 4.800 dollars par patient à consulation tardive et de 140 dollars par patient à hopita-lisation coordonnée. Bref, en 2003 dans la population étudiée, la plupart des patients avec IRCE ont eu besoin de HD urgente au début du traitement dialytique. Les jours à l’hôpital, la MM et les frais de traitement ont été élevés par rapport aux patients qui sont entrés coordonnés.

Summary Patients lately hospitalized for chronic dialysis (CD) are at high risk, especially those who are in urgent need for dialysis treatment. Since 1981, over 50% of the patients under CRF treatment in Uruguay, had started it without any preparation. The aim of this study is to search the number of patients who did late consultation, morbimortality rates (MM), and associated costs to this condition during 2003 in Uruguay. Patients with end-stage renal disease (ESRD) were prospectively included in the study: 81 patients were identified. Fifty six patients (69.1%) showed a significative delay in seeking consultation, needed 1 120 days of hospitalization (20 days/patient) and 578 hemodialysis sessions (HD) in specialized centers (10.3 DH/patient). Five patients had died before starting CD and 9 died during the six first months after starting CD. Twenty five patients (30.9%) received planned dialysis, spent 73 days at hospital (2.9 days/patient) and no deaths were recorded. Hospitalization cost were 4800$ per patient in the cases of late consultation compared to 140$ for the planned patients. In conclusion: during 2003, most of the patients of the study population with ESRD required urgent HD at the beginning of the treatment. Hospitalization lenght, MM, and treatment cost were higher in patients with late consultation compared to planned-treatment patients.