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[Oxcarbazepine in monotherapy in 324 patients with partial seizures (TRINOVA study)].

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.