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Evaluation of the effects of vigabatrin on cognitive abilities and quality of life in epilepsy

Department of Neurological Surgery (Dr. Dodrill), Regional Epilepsy Center, University of Washington School of Medicine, Seattle, WA; the Department of Psychiatry (Dr. Arnett), University of Manitoba, Winnipeg, Canada; and the Department of Clinical Research (Drs. Sommerville and Sussman), Marion Merrell Dow, Inc., Kansas City, MO.

We evaluated the psychological effects of the antiepilepsy drug vigabatrin in a randomized multi-center double-blind placebo-controlled parallel group study that compared 3 grams oral vigabatrin with placebo as daily add-on therapy in patients with focal epilepsy whose complex partial seizures were difficult to control, Testing at baseline and after 12 weeks of vigabatrin (n = 83) or placebo (n = 85) used eight measures of cognitive abilities and three of mood and adjustment. The vigabatrin and placebo groups were highly similar at entry into the study. At the end of the study, there were no differences between the vigabatrin and placebo groups on any cognitive variable or on any measure of mood and adjustment. Analysis of the results related to relief from seizures demonstrated only chance findings. In a similar manner, there were no relationships between vigabatrin serum levels at the end of the study and changes on measures of abilities and adjustment. Vigabatrin appears to be a useful antiepilepsy drug with little impact upon tests of either cognitive abilities or quality of life.

Address correspondence and reprint requests to Dr. Carl B. Dodrill, Regional Epilepsy Center (ZA-501, Harborview Medical Center, 325 Ninth Avenue, Seattle, WA 98104.

Supported by Marion Merrell Dow, Inc. Drs. Dodrill and Arnett were paid consultants of Marion Merrell Dow during the planning, execution, and analysis of the study and during the preparation of this report.

Received March 22, 1993. Accepted for publication in final form May 17, 1993.

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