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Migraine prophylaxis with divalproex

N T Mathew1, J R Saper, S D Silberstein

  • 1Headache Clinic, Houston, Tex.

Archives of Neurology
|March 1, 1995
PubMed
Summary
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Divalproex sodium significantly reduces migraine frequency and functional impairment compared to placebo. This study confirms divalproex as an effective and well-tolerated option for migraine prophylaxis.

Area of Science:

  • Neurology
  • Pharmacology

Background:

  • Migraine headaches represent a significant neurological disorder impacting quality of life.
  • Prophylactic treatments are essential for managing frequent or severe migraine episodes.

Purpose of the Study:

  • To evaluate the efficacy and safety of divalproex sodium versus placebo for migraine headache prophylaxis.
  • To compare migraine frequency, severity, and impact on daily functioning between treatment groups.

Main Methods:

  • A multicenter, double-blind, randomized, placebo-controlled trial.
  • 107 patients were randomized to receive divalproex sodium or placebo over a 12-week treatment phase.
  • Dosages were adjusted to achieve target serum valproate concentrations, with a baseline phase preceding treatment.

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Main Results:

  • Divalproex sodium significantly reduced mean migraine frequency per 4 weeks (3.5 vs. 5.7, p < .001) compared to placebo.
  • 48% of divalproex patients experienced a ≥50% reduction in migraine frequency versus 14% on placebo (P < .001).
  • Divalproex treatment led to less functional restriction and reduced symptomatic medication use, though peak severity and duration were similar.

Conclusions:

  • Divalproex sodium demonstrates significant effectiveness in migraine prophylaxis.
  • The drug is generally well-tolerated, with no significant differences in adverse events leading to discontinuation between groups.