Abstract Background: The effects of cinacalcet in persistent and/or hypercalcaemia-associated secondary hyperparathyroidism (SHPT) have been described in patients on dialysis. Objectives: To evaluate the efficacy and safety of cinacalcet in SHPT not on dialysis and its effects on bone turnover markers. Methods: Non-randomised, longitudinal, observational, analytical study of patients with chronic kidney disease (CKD) and SHPT (PTH> 80 pg/mL) as well as normo- or hypercalcaemia (≥8.5 mg/dL), treated with cinacalcet. Results: Mean cinacalcet dose was 30mg/day in 66.7%. We studied 15 patients (10 women), aged 66.0 ± 17.93years. The aetiology was unknown in 20% of cases. Sociodemographic variables and renal function parameters were recorded. We compared values at baseline as well as after 6 and 12 months. Calcium (10.3 ± 0.55 vs. 9.4 ± 1.04) and iPTH (392.4 ± 317.65 vs. 141.8 ± 59.26) levels decreased. Increased levels of phosphorus (3.7 ± 1.06 vs. 3.9 ± 0.85) and ß-CTX (884.2 ± 797.22 vs. 1053.6 ± 999.00) were detected, although there were no significant changes in GFR, urinary calcium or other bone markers. Two patients withdrew from the study (gastrointestinal intolerance and parathyroidectomy, respectively). Conclusions: Cinacalcet at low doses is effective in the management of SHPT in CKD patients who are not on dialysis. Its use reduces iPTH and calcaemia, without causing serious side effects or significant changes in renal function.
Resumen Antecedentes: Los efectos de cinacalcet en el hiperparatiroidismo secundario (HPTS), persistente o asociado a hipercalcemia han sido descritos en pacientes en diálisis. Objetivos: Analizar la eficacia y seguridad de cinacalcet en HPTS no sometido a diálisis y sus efectos sobre marcadores de recambio óseo. Métodos: Estudio analítico observacional, no aleatorizado, longitudinal, de pacientes con enfermedad renal crónica (ERC) e HPTS (PTH > 80 pg/mL); con normohipercalcemia (≥8,5 mg/dL), tratados con cinacalcet. Resultados: La dosis media de cinacalcet fue de 30mg/día en un 66,7%. Estudiamos 15 pacientes (10 mujeres), con edad de 66,0 ± 17,93 años. Etiología desconocida en 20% de los casos. Registramos variables sociodemográficas y parámetros de función renal. Comparamos valores basales, tras 6 y 12 meses. Descendieron los niveles de iPTH (392,4 ± 317,65 vs. 141,8 ± 59,26) y calcio (10,3 ± 0,55 vs. 9,4 ± 1,04). Aumentaron los valores de fósforo (3,7 ± 1,06 vs. 3,9 ± 0,85) y ß-CTX (884,2 ± 797,22 vs. 1.053,6 ± 999,00), sin variaciones significativas del FG, calciuria y demás marcadores óseos. Registrados 2 abandonos (intolerancia digestiva y paratiroidectomía, respectivamente). Conclusiones: Cinacalcet a dosis bajas es eficaz en el manejo del HPTS del paciente con ERC no tratado mediante diálisis, al disminuir la iPTH y la calcemia, sin ocasionar efectos adversos graves ni variación significativa de la función renal.