Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia.

BACKGROUND: Antiepileptic drugs are the first-line treatment for trigeminal neuralgia (TN). Carbamazepine and oxcarbazepine are the most studied with well-known efficacy. Eslicarbazepine acetate is a third-generation antiepileptic drug that has not previously been evaluated for the treatment of TN. We aim to assess the efficacy, tolerability and safety of eslicarbazepine for TN. DESIGN AND METHODS: Retrospective, open-label, multicentric, intention-to-treat study. We included patients older than 18 years who met the ICHD-3 beta diagnostic criteria for TN. We evaluated the variation of intensity and frequency of pain paroxysms before and after treatment with eslicarbazepine. Secondary objectives assessed were tolerability and safety of eslicarbazepine. RESULTS: Eighteen patients were included, 15 women, mean age 65.2 years old, mean follow-up 21.1 months. The mean number of drugs tested before eslicarbazepine was 2; 10 patients used eslicarbazepine as monotherapy. After the treatment with ESL, the median of pain intensity improved from 9.5 to 2.5 (p < 0.001) and the median of pain paroxysms frequency improved from 70 episodes per week to 0.37 (p < 0.001). Responder rate was 88.9%; 44.4% became asymptomatic after treatment. Sixty-one per cent of patients presented some adverse event; four patients discontinued eslicarbazepine for this reason. Despite this, 16 patients (88.9%) noticed a good subjective tolerance to eslicarbazepine. The retention rate at 6 months was 77.8% and at 12 months 61.1%. CONCLUSIONS: Our study supports the hypothesis that eslicarbazepine acetate is an effective, safe and well-tolerated treatment for the treatment of TN. Further studies are warranted to corroborate these results. SIGNIFICANCE: Eslicarbazepine acetate has shown to be an effective, safe and well-tolerated drug for TN. This is the first study that evaluated the efficacy of this drug on TN in humans.