Abstracts

BACKGROUND One of the main reasons for poor control and epileptic seizures in the pediatric population in Latin America is the lack of administration of drugs, in most of the time for economic reasons, which has favored using alternative generic molecules, in particular, because of its low cost. However, there are still no clinical studies proving the efficacy and safety of these molecules in controlling seizures in pediatric patients. We attach utmost importance to demonstrate whether these treatments can be an ideal drug of choice, which would ensure better attachment and seizure control of patients in developing countries. Medicine is considered a "generic" one who has shown an 'essential similarity' with the original product or 'brand', and which may be sold at lower prices. OBJECTIVE Describe and compare the efficacy and safety between the original molecule, generic Oxcarbazepine therapy in children with newly diagnosed partial epilepsy in a pediatric population with epilepsy in a National Institute of Health in Mexico City. METHODOLOGY STUDY DESIGN: Clinical trial. TYPE OF STUDY: Experimental, analytical, prospective and longitudinal. SPATIAL AND TEMPORAL LOCATION: The study was conducted at Children's Hospital of Mexico, in the period June 2009 to June 2010. POPULATION: We studied patients with newly diagnosed partial epilepsy and secondarily generalized partial epilepsy that began with antiepileptic drug therapy: Oxcarbazepine. SAMPLING METHOD: Random sampling, by the technique of balanced blocks and subsequently listed by a table of random numbers SAMPLE SIZE: As mentioned above there are no reports in the literature to show equivalence or noninferiority of an antiepileptic drug generic with respect to the original molecule in children with epilepsy, which was considered a pilot study. The pilot group is composed of two groups: 15 patients OXCBZ original molecule. 15 patients OXCBZ molecule generics. RESULTS With the original molecule was crisis management in 9 patients (81.82%) and two patients still had seizures (18.18%). As for adverse reactions 8 patients (72.72%) showed no adverse reaction rate and 3 patients (27.28%) had adverse reactions consisting of drowsiness. The average serum levels was 6.93 with a SD of 0.81. In relation to the control molecule generated crisis there in 6 patients (54.54%) and 5 patients still had seizures (45.46%). Adverse reactions in 7 patients (63.64%) showed no adverse reaction rate and 4 patients (36.36%) had adverse reactions consisting of drowsiness, headache, dizziness and trembling. Average levels of 5.55 with a SD of 0.99. CONCLUSIONS Oxcarbazepine is an antiepileptic effect in the treatment of partial epilepsy. The results of this study demonstrate differences, although not statistically significant between the original brand name drugs and generic, which requires larger population studies to establish significant differences. The original brand OXC proved more effective and safer usual therapeutic dose, serum doing better in relation to the generic brand drug. While achieving OXC generic brand seizure control, serum levels of this were lower as compared to the original brand name drug, so we infer that requires more doses to match the serum levels of original branded drugs. The difference was demonstrated between serum levels of both drugs, suggesting that serum levels are directly related to the type of molecule used and not to the individual.