Cinacalcet en pacientes en diálisis peritoneal con hiperparatiroidismo moderado-severoresistentes a tratamiento convencional. Estudio prospectivo a un año / No disponible

RESUMEN

Objetivos: Estudiar la eficacia de Cinacalcet(R) en el cumplimiento de las recomendaciones K/DOQI en pacientes en diálisis peritoneal (DP) y estimar el tiempo necesario para alcanzarlos. Métodos: Estudio observacional prospectivo de cohorte, con pacientes con hiperparatiroidismo-HPTH moderado severo(PTH > 500 pg/ml) con más de 4 meses en DP resistentes a tratamiento convencional con dieta, quelantes y vitamina D. Los objetivos óptimos son los recomendados por las Guías NKF-K/DOQI para ERC-5D y para el análisis de objetivos subóptimos se utilizan las referencias de PTH< 350 pg/ml.; fósforo < 6 mg/dl o calcio < 10,4 mg/dl (siempre ue simultáneamente CaxP < 55 mg2/dl2).Resultados: Al inicio del tratamiento con Cinacalcet(R) los 18 pacientes llevaban 15,56 meses (DE 0,78) en DP, todos tenían una PTH > 500 pg/ml, y ninguno cumplía los objetivos K/DOQI ni los subóptimos propuestos. El seguimiento medio en tratamiento con Cinacalcet(R) fue de 12 meses. El porcentaje de pacientes con PTH < 350 pg/ml fue de 66,7%a los 3 meses 60% a los 6 y 100% al año. A los tres meses el 33,3% cumplen todos los objetivos subóptimos, a los 6 meses el 33,3% y al año el 66,7%. El tiempo medio necesario para alcanzar un valor de PTH en rango fue de 2,33meses IC al 95% [1,35-3,32] y para alcanzar todos los objetivos óptimos de 16,94 meses [11,38-22,5]. La tolerancia a la medicación ha sido buena, no se suspendió Cinacalcet(R) en ningún caso y sólo en uno se redujo la dosis por efectos secundarios. Conclusión: La utilización de Cinacalcet® en pacientes en DP con HPTH resistente a tratamiento convencional ha resultado eficaz y segura y ha permitido mejorar el cumplimiento de objetivos de las guías (AU)

ABSTRACT

Background: Cinacalcet(R) has improved the management of hyperparathiroidism(HPTH) in hemodialysis. To our knowledge there are no specific studies on peritoneal dialysis (PD).Aim: The aim of the present study was to evaluate the efficacy of Cinacalcet(R) on the achievement of optimal and suboptimal targets on treatment of hyperparathiroidism (HPTH) in PD patients. As secondary objectives we have studied the safety of treatment and estimate the mean time to reach these targets, and evaluate economic cost. Methods: Eighteen patients undergoing more than 4 months on PD with a severe HPTH (PTH > 500 pg/ml) resistant to conventional treatment with diet, chelants and vitamin D were included in this prospective open-label study. We have used the targets of K/DOQITM-clinical guidelines as optimal target. We have selected as suboptimal targets PTH < 350 pg/ml, phosphorus< 6 mg/dl and calcium < 10.4 mg/dl (only when simultaneous CaxP was under 55 mg2/dl2). Oral Cinacalcet(R) was given with main meal in a single daily start dose of 30 mg and titrated thereafter monthly. We considered the first value on target as an event and used a Kaplan-Meyer survival analysis to estimate mean time to reach target. Results: On inclusion all patients have at least two previous PTH values over 500 pg/ml, PTH mean 695.3 (SD 96) and they were on PD with an appropriate efficacy during a mean of15.56 months (SD 0.78). Mean follow-up time under Cinacalcet(R) treatment was 12 months. The percentage of patients with a PTH under 350 pg/ml was 66.7% on month 3, 60% on month 6 and 100% after 1 year. The percentage of patients that reach an aggregate of all suboptimal targets (PTH < 350 pg/ml, phosphorus < 6 mg/dl and calcium < 10.4 mg/dl (only when simultaneous CaxP was under 55 mg2/dl2). Oral Cinacalcet(R) was given with main meal in a single daily start dose of 30 mg and titrated thereafter monthly. We considered the first value on target as an event and used a Kaplan-Meyer survival analysis to estimate mean time to reach target. Results: On inclusion all patients have at least two previous PTH values over 500 pg/ml, PTH mean 695.3 (SD 96) and they were on PD with an appropriate efficacy during a mean of 15.56 months (SD 0.78). Mean follow-up time under Cinacalcet(R) treatment was 12 months. The percentage of patients with a PTH under 350 pg/ml was 66.7% on month 3, 60% on month 6 and 100% after 1 year. The percentage of patients that reach an aggregate of all suboptimal targets (PTH < 350 pg/ml and calcium < 10.4 mg/dl and phosphorus < 6 mg/dl and CaxP < 55 mg2/dl2) was 33.3% on month 6 and 66.7% after 1 year. The mean time to reach PTH target was 2.33 months with a 95% confident interval [1,35-3,32] and to reach the aggregate of all target was 16.94 months [11,38-22,5]. Cinacalcet ® has been well tolerated, we reduced the dose in a single patient due to secondary effects, but treatment was not discontinued in any case. Conclussion In summary the addition of Cinacalcet(R) to conventional treatment in PD patients with resistant HPTH has improved the achievement of targets, and has been reasonably safe in our patients (AU)