Valproate as monotherapy for juvenile myoclonic epilepsy: dose-effect study

Ther Drug Monit. 1998 Apr;20(2):149-57. doi: 10.1097/00007691-199804000-00004.

Abstract

Sodium valproate enteric-coated tablets were used in this double-blind, randomized, cross-over study of 16 patients with juvenile myoclonic epilepsy comparing 1000 mg and 2000 mg VPA daily in b.i.d. administration with 6 months of observation on each dose. Myoclonic, absence, and generalized tonic-clonic seizures were registered separately. Subjective side-effects were monitored, and a computerized neuropsychologic test battery was performed on each dose. There was no significant difference in seizure frequency between the two doses. Only 25% of the patients were seizure free throughout the study despite concentrations well within the normally proposed therapeutic range for VPA. During the higher dose, 37.5% of the patients had an improved seizure control, but 25% of the patients had an increase in seizure frequency compared to the lower dose. However, there was no correlation between VPA concentrations and subjective side-effects or neuropsychologic test results. Our observations point out the possibility that the common strategy of increasing plasma levels in difficult-to-treat patients until side effects occur should perhaps be reconsidered, but this suggestion needs further confirmation.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anticonvulsants / adverse effects
  • Anticonvulsants / blood
  • Anticonvulsants / therapeutic use*
  • Area Under Curve
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Epilepsies, Myoclonic / drug therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Seizures / prevention & control
  • Sleep Stages / drug effects
  • Treatment Outcome
  • Valproic Acid / adverse effects
  • Valproic Acid / blood
  • Valproic Acid / therapeutic use*
  • Weight Gain / drug effects

Substances

  • Anticonvulsants
  • Valproic Acid