Administration of calcimimetics after dialysis: same effectiveness, better gastrointestinal tolerability.

INTRODUCTION: Cinacalcet has proved effective to control secondary hyperparathyroidism in patients on haemodialysis (HD). Some studies have reported an appropriate secondary hyperparathyroidism control and a better compliance after intradialytic use of calcimimetics. OBJECTIVES: To assess the effect of post-dialysis calcimimetics use on mineral bone disorders and calcimimetics gastrointestinal tolerability in our HD unit. MATERIAL AND METHODS: A 12-week single-centre prospective study in HD patients treated with cinacalcet (>2 months). Two study periods: Usual outpatient use (Stage 1) and use after HD session (Stage 2). ENDPOINTS: 1) Biochemical MBD data; 2) Gastrointestinal Symptom Rating Scale (GSRS) for gastrointestinal tolerability, and visual analogic scale (VAS) for satisfaction; 3) Adherence: Morisky-Green test (MG) and final tablet count (TC). RESULTS: Sixty-two HD patients. Fourteen received cinacalcet (22.5%). TEN patients were included, mean age was 60.9 years; patients had received HD for 80.9 months. Mean Charlson index: 9. Biochemical data: Stage 1 (initial vs. final): Ca 8.8 ± 0.5 vs. 9.1 ± 0.7 mg/dl (p<0.05); P 5.2 ± 0.8 vs. 4.5 ± 1.6 mg/dl, iPTH 360.3 ± 232.7 vs. 349 ± 122 pg/ml. MG: 70%. Stage 2 (initial vs. final): Ca 9.1 ± 0.7 vs. 8.8 ± 0.6 mg/dl; P 4.5 ± 1.6 vs. 4.6 ± 1.3 mg/dl, iPTH 360.3 ± 232.7 vs. 349 ± 122 pg/ml. TC: 89%. GSRS and VAS were better in Stage 2 (GSRS 7.5 ± 5.2 vs. 4.3 ± 1.9; VAS 4.8 ± 2.3 vs. 6.9 ± 2.8). No significant changes were observed in calcimimetic dose (201 vs. 207 mg/wk), number of phosphate binders (9 vs. 8.2 pts/day), native vitamin D (70 vs. 60%), selective vit D receptor activators (30%), or suitable dialysis parameters. CONCLUSIONS: Post-dialysis use of calcimimetic was effective in secondary hyperparathyroidism control, improved gastrointestinal tolerability and ameliorated patients' satisfaction. Based on our findings, post-dialysis use of calcimimetics should be considered in selected patients with low therapeutic compliance.

Administración de calcimiméticos posdiálisis: igual efectividad, mejor tolerancia gastrointestinal / Administration of calcimimetics after dialysis: same effectiveness, better gastrointestinal tolerability

Introducción: Cinacalcet resulta efectivo en el control del hiperparatiroidismo secundario de los pacientes en hemodiálisis (HD). Algunos estudios han reportado un buen control del hiperparatiroidismo secundario y un mejor cumplimiento terapéutico tras la administración de calcimiméticos intradiálisis. Objetivos: Analizar el efecto de la administración de calcimiméticos posdiálisis sobre el metabolismo óseo mineral y la tolerancia gastrointestinal en nuestra unidad de HD. Material y métodos: Estudio prospectivo unicéntrico de 12 semanas de duración en pacientes en HD tratados con cinacalcet (>2 meses). Dos períodos de estudio (6 semanas): Administración habitual ambulatoria (fase 1) y posthemodiálisis (fase 2). Datos analizados: 1.- Datos bioquímicos metabolismo óseo mineral. 2.-Test síntomas gastrointestinales (Gastrointestinal Symptom Rating Scale [GSRS]) y grado de satisfacción (escala visual analógica [EVA]). 3.-Adherencia: Test de Morisky-Green (MG) y recuento final comprimidos (RC). Resultados: Sesenta y dos pacientes en HD. Catorce recibían cinacalcet (22,5%). Diez pacientes incluidos, edad media 60,9 años y 80,9 meses en HD. Charlson medio: 9. Datos bioquímicos: fase 1 (inicio vs. fin): Ca 8,8±0,5 vs. 9,1±0,7mg/dl (p<0,05); fósforo 5,2±0,8 vs. 4,5±1,6mg/dl, PTHi 353±129 vs. 360±232pg/ml. Adherencia (MG): 70%. Fase 2 (inicio vs. fin): Ca 9,1±0,7 vs. 8,8±0,6mg/dl; fósforo 4,5±1,6 vs. 4,6±1,3mg/dl; PTHi 360,3±232,7 vs. 349±122pg/ml. Adherencia (RC): 89%. Con relación al GSRS y el grado de satisfacción, fueron mejores en la fase 2 (GSRS 7,5±5,2 vs. 4,3±1,9; EVA 4,8±2,3 vs. 6,9±2,8). No se objetivaron cambios significativos en la dosis de calcimiméticos (201 vs. 207mg/sem), número captores fósforo (9 vs. 8,2pac/día), vitamina D nativa (70 vs. 60%) o activadores selectivos receptor vitD (30%), ni en los parámetros de adecuación dialítica. Conclusiones: La administración de calcimiméticos post diálisis permitió controlar el hiperparatiroidismo secundario de forma eficaz, mejorando la sintomatología gastrointestinal y el grado de satisfacción. Se debe considerar la administración de calcimiméticos post diálisis en aquellos pacientes con escaso cumplimiento terapéutico (AU)

Introduction: Cinacalcet has proved effective to control secondary hyperparathyroidism in patients on haemodialysis (HD). Some studies have reported an appropriate secondary hyperparathyroidism control and a better compliance after intradialytic use of calcimimetics. Objectives: To assess the effect of post-dialysis calcimimetics use on mineral bone disorders and calcimimetics gastrointestinal tolerability in our HD unit. Material and methods: A 12-week single-centre prospective study in HD patients treated with cinacalcet (>2 months). Two study periods: Usual outpatient use (Stage 1) and use after HD session (Stage 2). Endpoints: 1) Biochemical MBD data; 2) Gastrointestinal Symptom Rating Scale (GSRS) for gastrointestinal tolerability, and visual analogic scale (VAS) for satisfaction; 3) Adherence: Morisky-Green test (MG) and final tablet count (TC). Results: Sixty-two HD patients. Fourteen received cinacalcet (22.5%). TEN patients were included, mean age was 60.9 years; patients had received HD for 80.9 months. Mean Charlson index: 9. Biochemical data: Stage 1 (initial vs. final): Ca 8.8±0.5 vs. 9.1±0.7mg/dl (p<0.05); P 5.2±0.8 vs. 4.5±1.6mg/dl, iPTH 360.3±232.7 vs. 349±122 pg/ml. MG: 70%. Stage 2 (initial vs. final): Ca 9.1±0.7 vs. 8.8±0.6mg/dl; P 4.5±1.6 vs. 4.6±1.3mg/dl, iPTH 360.3±232.7 vs. 349±122 pg/ml. TC: 89%. GSRS and VAS were better in Stage 2 (GSRS 7.5±5.2 vs. 4.3±1.9; VAS 4.8±2.3 vs. 6.9±2.8). No significant changes were observed in calcimimetic dose (201 vs. 207mg/wk), number of phosphate binders (9 vs. 8.2 pts/day), native vitamin D (70 vs. 60%), selective vit D receptor activators (30%), or suitable dialysis parameters. Conclusions: Post-dialysis use of calcimimetic was effective in secondary hyperparathyroidism control, improved gastrointestinal tolerability and ameliorated patients’ satisfaction. Based on our findings, post-dialysis use of calcimimetics should be considered in selected patients with low therapeutic compliance (AU)