RUSSIAN OBSERVATIONAL SURVEY OF THE SHORT-TERM EFFICACY AND TOLERABILITY OF SUSTAINED-RELEASE SODIUM VALPROATE (DEPAKINE CHRONOSPHERA®) AS A FIRST-LINE DRUG IN THE TREATMENT OF EPILEPSY

Objective. To have additional data on the short-term safety and efficacy of sustained-release valproate (Depakine Chronosphera®, Sanofi- Aventis, France) used as both first-line monotherapy and additional therapy in children and adolescents with epilepsy.

Subjects and methods. This open-label, noncomparative, prospective, short-term survey enrolled 1010 patients aged 1 month and 72 years (mean age 10,9±12,4 years). Three hundred (29,7%) patients had unspecified epilepsy; 40 (3,96%) had idiopathic focal epilepsy; 428 (42,38%) had presumptively symptomatic and symptomatic focal epilepsy; 117 (16,93%) had idiopathic generalized epilepsy, 71 (7,03%) had epileptic encephalopathy; 52 (5,15%) had West's syndrome. The starting dose of Depakine Chronosphera® was 10-15 mg/day; the mean therapeutic dose was 20-30 mg/kg/day. When there was no adequate response, the dose might be increased up to 50-60 mg/kg/day, by meticulously monitoring a patient's status. Depakine Chronosphera® was used both alone and in combination with other antiepileptic drugs (AED). The follow-up lasted at least 2 months.

Results. The most common reason for using Depakine Chronosphera® was ineffective previous treatment with AED (24,7% of cases) and easiness to use. Due to the therapy, epileptic seizures ceased in 405 (40,1%) patients; their number reduced by 75 and 50% in 248 (24,55%) and 272 (26,93%) patients, respectively; therapy failed in 55 (5,45%) patients; seizure aggravation was noted in 7 (0,69%); there was no information on changes in the frequency of seizures in 23 (2,28%). Since Depakine Chronosphera® is intended mainly for both preschool children and older patients who have difficulties in taking the drug as tablets, the study group comprised children less than 7 years of age. Nevertheless, the drug was also actively given to children over 7 years and adults. This was associated with not only with the physician's interest in the new formulation of the drug, but also with its easiness to use. Adverse reactions were observed in 8,91% of the patients. The spectrum and frequency of side effects corresponded to those in the similar studies.

Conclusion. The study has indicated that the use of Depakine Chronosphera® as monotherapy and multimodality treatment for epilepsy in adults and children is effective and safe. The low discontinuance rate of the drug suggests its good tolerability and efficacy, as well as easiness to use, in early preschool children in particular. The use of Depakine Chronosphera® is promising in treating epilepsy in adults and children

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