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FDA aprueba un nuevo medicamento complementario para tratar el Párkinson
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La Administración de Drogas y Alimentos de los Estados Unidos (FDA por sus siglas en inglés) aprobó esta semana las tabletas de Nourianz (istradefylline) como un tratamiento adicional para la levodopa/carbidopa en pacientes adultos con enfermedad de Parkinson (EP) que experimentan episodios “off”.
Un episodio “off” es un momento en que los medicamentos de un paciente no funcionan bien y causan un aumento de los síntomas de la enfermedad de Parkinson, como temblor y dificultad para caminar.
Según los Institutos Nacionales de Salud, el Parkinson es el segundo trastorno neurodegenerativo más común en Estados Unidos después de la enfermedad de Alzheimer.
Se estima que 50,000 estadounidenses son diagnosticados con Parkinson cada año y aproximadamente un millón de estadounidenses tienen la afección.
El trastorno neurológico generalmente ocurre en personas mayores de 60 años, aunque puede ocurrir antes.
Ocurre cuando las células en el cerebro, que producen una sustancia química llamada dopamina, se deterioran o mueren.
La dopamina ayuda a transmitir señales entre las áreas del cerebro que producen movimientos suaves y decididos, como comer, escribir y afeitarse.
Los primeros síntomas de la enfermedad son sutiles y generalmente empeoran gradualmente; sin embargo, la enfermedad progresa más rápidamente en algunas personas que en otras.
El nuevo tratamiento
La efectividad de Nourianz en el tratamiento de episodios “off” en pacientes con Parkinson que ya están siendo tratados con levodopa/carbidopa se demostró en cuatro estudios clínicos controlados con placebo de 12 semanas que incluyeron un total de 1,143 participantes.
En los cuatro estudios, los pacientes tratados con Nourianz experimentaron una disminución estadísticamente significativa desde el inicio en el tiempo “off” diario en comparación con los pacientes que recibieron un placebo.
Las reacciones adversas más comunes observadas en pacientes que toman Nourianz fueron movimiento muscular involuntario (discinesia), mareos, estreñimiento, náuseas, alucinaciones e insomnio (insomnio).
Se debe monitorizar a los pacientes para el desarrollo de discinesia o exacerbación de la discinesia existente.
Si se producen alucinaciones, comportamiento psicótico o comportamiento impulsivo / compulsivo, se debe considerar una reducción de la dosis o la suspensión de Nourianz.
No se recomienda el uso de Nourianz durante el embarazo. Se debe recomendar a las mujeres en edad fértil que utilicen métodos anticonceptivos durante el tratamiento.
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