Clinical efficacy and tolerability of magnesium valproate as monotherapy in patients with generalised or partial epilepsy - A nonblinded study of 320patients

Objective: To determine the efficacy and tolerability of magnesium valproat e as monotherapy in patients with partial or generalised epilepsy. Design and Setting: This was a nonblinded study performed at 39 centres in Italy. Patients and Participants: 320 male or female patients aged 2 to 65 years w ho were experiencing absence, myoclonic, clonic, tonic, tonic-clonic, atoni c, simple, complex or secondarily generalised seizures or a combination of these related to generalised or partial epilepsy. Methods: The study consisted of a 4-week baseline period and a 24-week trea tment period for a total of 7 months. Patients received magnesium valproate at between 100 and 2100 mg/day depending on bodyweight and seizure type. T he dosage was adjusted to achieve valproate plasma concentrations in the ra nge of 50 to 100 mg/L. Results: A total of 258 patients completed the study. There was a significa nt reduction in the frequency of all seizure types with magnesium valproate . A greater than or equal to 50% decrease in seizures was observed for all seizure types in 236 (95.2%) of evaluable cases. Furthermore, a complete re mission was seen in all patients with clonic, tonic, atonic or secondarily generalised seizures. This reduction in all types of seizures was seen with valproate plasma concentrations mostly in the range of 50 to 100 mg/L. Onl y 4.3% of the adverse events were considered to be serious. Conclusions: This study shows that magnesium valproate is effective as mono therapy in patients with newly diagnosed or previously treated partial or g eneralised epilepsy.