SAFETY OF INTRAVENOUS VALPROATE

This multicenter, open-label trial was designed to study the safety of intravenous (IV) sodium valproate in patients with epilepsy. All 318 patients (previously treated with antiepileptic drugs) were hospitaliz ed for seizure control or anticipated seizures. The protocol allowed p hysicians to set the number of infusions and treatment duration. Adver se events, laboratory studies performed, and seizure activity were doc umented on case report forms. The patients' mean age was 34.4 years (r ange, 2-87 years). The most common reason for admission was lack of se izure control (235 patients, 185 of whom were admitted for video-elect roencephalographic monitoring). The median dosage of valproate was 375 mg infused over 1 hour. The median number of doses was four, given ov er 2 days. In 54 patients (17%), transient adverse events were reporte d. The most frequent were headache, reaction at the injection site, an d nausea (2.2% each); somnolence (1.9%); vomiting (1.6%); and dizzines s and taste perversion (1.3% each). No persistent or severe hematologi c or serum chemistry abnormalities were found. Vital signs were not si gnificantly affected by the IV infusion of valproate. At the dosages a nd rates of administration studied, intravenous valproate appears to b e safe and well tolerated.