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.

• Authors: Yingying Su, Huijin Huang, Mengdi Jiang, Suyue Pan, Li Ding, Le Zhang, Wen Jiang, Xiaorong Zhuang
• Journal: Epilepsy research (Epilepsy Res) Vol. 177 Pg. 106755 (Nov 2021) ISSN: 1872-6844 [Electronic] Netherlands
• PMID: 34517272 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2021 Elsevier B.V. All rights reserved.

Chemical References

• Anticonvulsants
• Valproic Acid
• Phenobarbital

Topics

• Adult
• Anticonvulsants (therapeutic use)
• China
• Humans
• Phenobarbital (therapeutic use)
• Prospective Studies
• Status Epilepticus (chemically induced, drug therapy)
• Valproic Acid (therapeutic use)