Prevalence and risk factors of baclofen neurotoxicity in patients with severely impaired renal function

Background/aims: The most common adverse effect of baclofen, used for managing hiccups and spasticity, is neurotoxicity. As baclofen is primarily excreted by the kidneys, neurotoxicity is more likely to occur in patients with chronic kidney disease (CKD). We evaluated the risk factor for baclofen neurotoxicity and the recommended dosage for patients with severe CKD. Methods: In this single-center retrospective study, we classified 401 patients with CKD as stage 4 (n = 174), non-dialysis stage 5 (n = 97), and on-dialysis (n = 130). Results: The prevalence of baclofen-induced neurotoxicity in patients with severe CKD was 7.0% (28 of 401 patients). There was no significant difference in the presence of neurotoxicity when the patients were classified as CKD stage 4, stage 5, and dialysis patients. There were significant differences in serum albumin levels and the presence of diabetic nephropathy between the patients with neurotoxicity and those without. The results from a multiple logistic regression analysis showed that serum albumin was independently associated with baclofen neurotoxicity (p = 0.007). The minimum daily dose for baclofen neurotoxicity was 10 mg, 10 mg, and 5 mg in patients with CKD stages 4 and 5, and dialysis, respectively. Conclusions: In this study, the prevalence of baclofen-induced neurotoxicity in patients with severe CKD was 7.0%. Serum albumin was identified as an independent risk factor for neurotoxicity. We recommend initially administering a daily dose of 7.5 mg for patients with severe CKD stages 4 and 5, and a daily dose of 2.5 mg for patients receiving dialysis. Resumen: Antecedentes/objetivos: La neurotoxicidad es el efecto adverso más frecuente del baclofeno, un fármaco que se utiliza para tratar los espasmos y la espasticidad. Dado que el baclofeno se excreta principalmente a través de los riñones, es más probable que la neurotoxicidad se presente en pacientes con enfermedad renal crónica (ERC). Hemos evaluado el factor de riesgo para la neurotoxicidad por baclofeno y la dosis recomendada para pacientes con ERC grave. Métodos: En este estudio retrospectivo unicéntrico, se clasificó a 401 pacientes con ERC en estadio 4 (n = 174), estadio 5 sin diálisis (n = 97) y en diálisis (n = 130). Resultados: La prevalencia de la neurotoxicidad inducida por baclofeno en pacientes con ERC grave fue del 7,0% (28 de 401 pacientes). No se observaron diferencias significativas en la presencia de neurotoxicidad al clasificar a los pacientes en