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Vigabatrin for refractory complex partial seizures

Multicenter single-blind study with long-term follow-up

Departments of Neurology and Pharmacology and Experimental Therapeutics, Boston University School of Medicine and Boston Veterans Administration Medical Center (Dr. Browne and Mr. Szabo), Boston, MA; the Department of Neurology, Yale University School of Medicine and West Haven Veterans Administration Medical Center (Dr. Mattson), New Haven, CT; the Department of Neurology, Bowman Gray School of Medicine of Wake Forest University and North Carolina Baptist Hospital (Dr. Penry), Winston-Salem, NC; the Good Samaritan Hospital and Medical Center (Dr. Smith), Portland. OR; the Department of Neurology. University of California, Los Angeles and Wadsworth Veterans Administration Medical Center (Drs. Treiman and Ben-Menachem), Los Angeles, CA; the Departments of Neurology and Neuroscience, University of Florida College of Medicine and Gainesville Veterans Administration Medical Center (Dr. Wilder), Gainesville, FL; and the Merrell Dow Research Institute (Dr. Napoliello and Mr. Sherry), Cincinnati, OH.

The irreversible GABA transaminase inhibitor vigabatrin (VGB) was given in a single-blind fashion to 89 patients with complex partial seizures (CPS) refractory to conventional drugs. The median number of CPS per month decreased from 11.0 to 5.0 after addition of VGB, and 51% of patients had a 50% or greater decrease in CPS frequency (p < 0.001). Side effects (principally drowsiness, ataxia, and headache) occurred mainly during the initiation of therapy and decreased during therapy. After 12 weeks on VGB, side effects significantly interfered with functioning in only 13% of patients, and the efficacy:toxicity ratio warranted continued administration in 74% of patients. Coadministration of VGB resulted in a mean decrease of 20% in phenytoin serum concentration (p < 0.001). Sixty-six patients with a favorable response to VGB during the single-blind study have been followed for a median of 16.7 months on VGB. No serious systemic or neurologic toxicity has been detected, and most patients have retained their initial favorable CPS control.

Address correspondence and reprint requests to Dr. Browne, Department of Neurology, Veterans Administration Medical Center, 150S. Huntington Avenue, Boston, MA 02130.

Supported in part by the Merrell Dow Research Institute

Presented in part at the thirty-sixth annual meeting of the American Academy of Neurology, Boston. MA, April 1984 and at the thirty-seventh annual meeting of the American Academy of Neurology, Dallas, TX, May 1985.

Received May 5, 1986. Accepted for publication June 17, 1986

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