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Interchangeability among therapeutics equivalents of lamotrigine in the treatment of refractory epilepsy patients: risks and benefits

B.M.P Girolineto, V. Alexandre Jr., R.H.C Queiroz, F. Feletti, A.C. Sakamoto, L.R.L Pereira [REV NEUROL 2010;51:330-336] PMID: 20839169 DOI: https://doi.org/10.33588/rn.5106.2010382

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Volumen 51 | Number 06 | Nº of views of the article 7.290 | Nº of PDF downloads 726 | Article publication date 16/09/2010

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ABSTRACT

INTRODUCTION Epilepsy is a condition characterized by signs and symptoms of neurological disorder. Lamotrigine has been widely used, mainly due to their greater tolerability and lower rate of drug interactions with other antiepileptic drugs however the newest antiepileptic drugs have high cost to patient. In Brazil there are three different sort of pharmaceutical equivalents (reference, generic and similar), and the Brazilian health care authorities offers to users the possibility to receive them free of charge. Moreover these pharmaceutical equivalents can change during the treatment of epilepsy because this authorities buy the cheapest by public tender two or three times a year.

AIM To evaluate the clinical and laboratory findings related to the most frequently used therapeutic equivalents of lamotrigine (reference drugs and similar products).

PATIENTS AND METHODS Two similar formulations (A and B) and one reference (C) were tested in nine epileptic refractory patients. The study was divided into three periods of 42 days, one for each formulation, and medical data about the frequency of seizures, the occurrence of side effects and measurement of plasma concentrations of lamotrigine were collected.

RESULTS The average number of seizures/week and plasma concentration of lamotrigine for formulations A, B and C were not statistically significant differences. Three patients during the use of the formulation C presented mild and transitory side effects. CONCLUSION. Similar or reference drugs showed satisfactory results, however the interchangeability among the formulations raise the difficulty for the management of seizures in refractory epilepsy. KeywordsEpilepsy Equivalents therapeutics Interchangeability Lamotrigine Plasma concentration Seizure CategoriesEpilepsias y síndromes epilépticos

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Original

Interchangeability among therapeutics equivalents of lamotrigine in the treatment of refractory epilepsy patients: risks and benefits