[Valproate (depakine chrono) in adult patients with partial epilepsy: results of a multicentral prospective non-comparative study].
We present results of an open multicentral prospective non-comparative clinical study on the efficacy and tolerability of depakine-chrono in patients with newly or recently diagnosed partial epilepsy (VIPe-1) that has been carried out in the Russian Federation. The study included 299 patients. It's duration was 6 months. Efficacy and tolerability of the drug used in mean dose 1479.0±448.7 mg/day were evaluated. After 6 month of treatment, 65.9% (95% CI 60.2 -71.2%) of patients were seizure-free. There was no significant difference in seizure-free rate in patients with different types of focal seizures. The improvement assessed with the Clinical Global Impression Scale (CGI) was seen in 73.3% of patients. Adverse events (mild or moderate) were recorded in 8% of patients. The most common adverse events were weight gain in (1.7%), hair loss (1.7%) and gastrointestinal disorders (1.3%). A serious adverse event (thrombocytopenia) occurred only in one case (0.3%). The results confirmed the high efficacy and good tolerability of depakine-chrono as first line monotherapy in adult patients with partial epilepsy.
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D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000175:diagnosis; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012074:Remission Induction; D013921:Thrombocytopenia / Q000139:chemically induced / Q000175:diagnosis; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D000927:Anticonvulsants; D014635:Valproic Acid