Phenobarbital versus valproate for generalized convulsive status epilepticus in adults (2): A multicenter prospective randomized controlled trial in China (China 2-P vs. V)

Abstract

Objective: A multicenter study of phenobarbital versus valproate (i.e., the China 2-P vs. V study) was conducted to compare the efficacy and safety of phenobarbital and valproate for generalized convulsive status epilepticus (SE) in a multicenter trial design.

Methods: Three improvements (uniform intravenous pumping, pump speed adjustment according to adverse events and blood drug level monitoring) over a previous study were made regarding an intravenous regimen of phenobarbital and valproate in a multicenter, prospective, randomized, controlled study. Long-term electroencephalography (EEG) monitoring was performed after initial drug treatment. Termination, relapse, adverse event and poor prognosis rates in patients with generalized convulsive status epilepticus (GCSE) were compared.

Results: The rate of GCSE termination within one hour were significantly higher in the phenobarbital group (33 cases) than in the valproate group (36 cases) (84.8 % vs. 63.9 %, P = 0.048), but the rates of nontermination of EEG epileptic discharge within one hour were similar between the two groups (12.1 % vs. 8.3 %, P = 0.702). The relapse and adverse event rates were not significantly different between groups, but 3 hypoventilation events and 1 hypotension event occurred in the phenobarbital group compared to 0 in the valproate group. There were no cases of epileptiform EEG discharge relapse in the phenobarbital group, compared to 1 case in the valproate group.

Conclusions: The phenobarbital regimen evaluated in this study has a higher GCSE termination rate than the valproate regimen, indicating that the former is suitable for countries, regions and individuals with limited access to new antiepileptic drugs or limited economic means.

Keywords: ADR; GCSE; Phenobarbital; Relapse rate; Termination rate.