Estudio prospectivo, abierto, controlado y aleatorizado de clobazam frente a carbamacepina en pacientes con crisis frecuentes de epilepsia rolándica / A prospective, open, controlled and randomised study of clobazam versus carbamazepine in patients with frequent episodes of rolandic epilepsy

Resumen. Introducción. No existen estudios controlados, aleatorizados y con régimen de dosificación flexibles en niños con epilepsia rolándica, por lo que la terapia es aún empírica. Objetivo. Evaluar la eficacia y la tolerabilidad del clobazam (CLB) comparado con la carbamacepina (CBZ) en la epilepsia rolándica. Pacientes y métodos. Estudio prospectivo, abierto, controlado, aleatorizado de CBZ frente a CLB en niños con epilepsia rolándica con seguimiento durante dos años. Se aleatorizaron 45 pacientes y terminaron el estudio 38 sujetos. Se indicó un régimen de dosificación flexible. Se evaluó el control de crisis, el rendimiento escolar, el comportamiento, la adherencia al tratamiento, el grado de satisfacción de los padres y el perfil de efectos adversos. Resultados. Ambos medicamentos fueron igualmente eficaces para controlar las crisis (el 94,1% de pacientes con CLB y el 100% con CBZ estaban libres de crisis al finalizar el estudio; p = 0,26). El CLB logró controlar las crisis más tempranamente (33,3 ± 45 frente a 48,2 ± 72,3 días; p < 0,05) y tuvo menos efectos adversos que la CBZ (aparecieron efectos adversos en tres pacientes con CLB y ocho con CBZ; p = 0). En dos pacientes en régimen de CBZ, las crisis empeoraron y junto con ello aparecieron complicaciones cognitivoconductuales. Conclusiones. La CBZ es un medicamento eficaz en la epilepsia rolándica, pero puede asociarse a un empeoramiento de las crisis, así como a déficit cognitivos y conductuales. El CLB en monoterapia parece ser un fármaco eficaz y mejor tolerado en este tipo de epilepsia (AU)

Summary. Introduction. To date no controlled, randomised studies with flexible dose regimens have been conducted in children with rolandic epilepsy, and therapy is therefore still empirical. Aim. To evaluate the effectiveness and safety of clobazam (CLB) compared with that of carbamazepine (CBZ) in rolandic epilepsy. Patients and methods. A prospective, open, controlled and randomised study was carried out to compare CBZ and CLB in children with rolandic epilepsy with a follow-up over a twoyear period. A random sample of 45 patients was taken and 38 of them finished the study. A flexible dose regimen was indicated. Control of seizures, academic performance, behaviour, adherence to treatment, parents’ degree of satisfaction and side effect profiles were all evaluated. Results. Both drugs were equally effective at controlling seizures (94.1% of patients with CLB and 100% of those with CBZ were free of seizures on ending the study; p = 0.26). CLB controlled seizures earlier (33.3 ± 45 days versus 48.2 ± 72.3; p < 0.05) and had fewer side effects than CBZ (side effects appeared in three patients with CLB and in eight of those on CBZ; p = 0). In two of the patients taking CBZ, the seizures got worse and a series of cognitive-behavioural complications also appeared. Conclusions. CBZ is an effective drug in rolandic epilepsy, but it may be associated with exacerbation of seizures as well as with cognitive-behavioural impairment. CLB in monotherapy seems to be an effective and better tolerated drug in this kind of epilepsy (AU)

[A prospective, open, controlled and randomised study of clobazam versus carbamazepine in patients with frequent episodes of Rolandic epilepsy]. / Estudio prospectivo, abierto, controlado y aleatorizado de clobazam frente a carbamacepina en pacientes con crisis frecuentes de epilepsia rolándica.

INTRODUCTION: To date no controlled, randomised studies with flexible dose regimens have been conducted in children with rolandic epilepsy, and therapy is therefore still empirical. AIM: To evaluate the effectiveness and safety of clobazam (CLB) compared with that of carbamazepine (CBZ) in rolandic epilepsy. PATIENTS AND METHODS: A prospective, open, controlled and randomised study was carried out to compare CBZ and CLB in children with rolandic epilepsy with a follow-up over a two-year period. A random sample of 45 patients was taken and 38 of them finished the study. A flexible dose regimen was indicated. Control of seizures, academic performance, behaviour, adherence to treatment, parents' degree of satisfaction and side effect profiles were all evaluated. RESULTS: Both drugs were equally effective at controlling seizures (94.1% of patients with CLB and 100% of those with CBZ were free of seizures on ending the study; p = 0.26). CLB controlled seizures earlier (33.3 +/- 45 days versus 48.2 +/- 72.3; p < 0.05) and had fewer side effects than CBZ (side effects appeared in three patients with CLB and in eight of those on CBZ; p = 0). In two of the patients taking CBZ, the seizures got worse and a series of cognitive-behavioural complications also appeared. CONCLUSIONS: CBZ is an effective drug in rolandic epilepsy, but it may be associated with exacerbation of seizures as well as with cognitive-behavioural impairment. CLB in monotherapy seems to be an effective and better tolerated drug in this kind of epilepsy.