Riluzol as treatment of the amyotrophic lateral sclerosis
Introduction. The Amyotrophic Lateral Sclerosis (ALS) is a disease characterized by the selective degeneracy of the superior motoneurons of the cortex motor and of the inferior motoneurons at level of the encephalic trunk and spinal marrow. Exist sporadic and familiar forms, being estimated an incidence of 1-2 cases by 100,000 inhabitants. The cause of the neuronal degeneracy is yet unknown, being implied, between other mechanisms, the glutamic exotoxicity is the responsible for the death neuronal. The riluzol is a benzothiazole derivative whose neuroprotector mechanism still it has not been totally clarified, though seems that reduces the neuroexcitatory action of the glutamic acid blocking his transmission. Development. Two clinical trials have been accomplished with similar characteristics: multicentre, randomized, double blind, and placebo-controlled. Between both studies have been included more than 1,100 patient, obtained significant statistic results in the prolongation of the survival time, however this effect was not going accompanied of an improvement in the muscular force neither of the pulmonary capacity, what is translated in which the riluzol does not modify the quality of life of the patient. The drug presents good tolerance and mild adverse effects and as consequence of this in 1996, the FDA approved his marketing and utilization in the treatment of the ALS. The approval of the riluzol as first agent for the treatment of the ALS has raised an important number of problems about the efficiency and cost of the treatment. Conclusion. Though its benefits are modest, it is considered a starting point in the pharmacotherapy of the ALS
Desarrollo Se han realizado dos ensayos clínicos de características similares, aleatorios, doble ciego, multicéntricos y controlados con placebo. Entre ambos estudios se han incluido más de 1.100 pacientes y se han obtenido resultados estadísticamente significativos en la prolongación del tiempo de supervivencia; sin embargo, este efecto no va acompañado de una mejoría en la fuerza muscular, ni de la capacidad pulmonar, lo que se traduce en que el riluzol no modifica la calidad de vida del paciente. El fármaco presenta buena tolerancia y efectos secundarios leves y, como consecuencia de ello, en 1996, la FDA aprobó su comercialización y utilización en el tratamiento de la ELA.
Conclusión La aprobación del riluzol como primer agente para el tratamiento de la ELA ha suscitado un número importante de cuestiones acerca de la eficacia y coste del tratamiento. Aunque sus beneficios son modestos, se trata de un punto de partida en la farmacoterapia de la ELA