Oxcarbacepina en monoterapia en 324 pacientes con crisis parciales (estudio TRINOVA) / Oxcarbazepine in monotherapy in 324 patients with partial seizures (trinova study)

RESUMEN

Objetivo. Valorar la eficacia y la tolerabilidad de la oxcarbacepina (OXC) en monoterapia en pacientes con crisis parciales, como primera alternativa terapéutica o tras el fracaso de otras monoterapias. Pacientes y métodos. Estudio multicéntrico abierto, de observación, prospectivo, de 324 pacientes de 6-87 años de edad, con crisis parciales no tratados previamente con fármacos antiepilépticos (FAE) (n = 114) o con fracaso de otras monoterapias (n = 210), a los que se administró OXC en las condiciones habituales de la práctica clínica a lo largo de 52 semanas; se valora la eficacia a través de la reducción de la frecuencia de crisis, la tolerabilidad, con los efectos adversos relacionados con el fármaco, y la calidad de vida mediante los cambios objetivados en los cuestionarios CAVE en niños y QOLIE-31 en adultos. Resultados. Al concluir el estudio, el control total de las crisis ha sido del 73,7 por ciento en los pacientes no tratados previamente, y del 43,8 por ciento en los que habían fracasado otras monoterapias, mejorando simultáneamente los parámetros de calidad de vida. El 42,9 por ciento ha referido efectos adversos, habitualmente tolerables o transitorios, ya que han motivado la anulación de OXC solamente en el 9,6 por ciento de los pacientes. Conclusiones. OXC es un FAE muy eficaz y bien tolerado en monoterapia en pacientes de todas las edades con crisis parciales, como primera opción terapéutica o sustituyendo a otros fármacos ineficaces o mal tolerados (AU)

ABSTRACT

Aims. The purpose of this study was to evaluate the effectiveness and tolerability of oxcarbazepine (OXC) administered as monotherapy in patients with partial seizures as a first therapeutic alternative or after the failure of other monotherapies. Patients and methods. A prospective, open, multicentre trial based on observation involving 324 patients between 6 and 87 years of age with partial seizures who had not received prior treatment with antiepileptic drugs (AED) (n = 114) or in whom other monotherapies had failed (n = 210). These patients were administered OXC in the conditions usually found in clinical practice over a period of 52 weeks; effectiveness was evaluated by the reduction in the frequency of the seizures, tolerability was measured through the side effects related to the drug and quality of life was assessed by means of the changes reflected in the CAVE questionnaires, in the case of children, and the QOLIE-31 for adults. Results. At the end of the study, total control over the seizures was 73.7% in patients who had not been treated previously and 43.8% in those in whom other monotherapies had failed; at the same time there was an improvement in the quality of life parameters. 42.9% reported side effects, which were usually tolerable or transient since they led to the withdrawal of OXC in only 9.6% of the patients. Conclusions. OXC is a very effective AED and is well tolerated as monotherapy in patients of all ages with partial seizures, either as the first choice therapy or as a substitution for other ineffective or poorly tolerated drugs