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A Randomized, Controlled Study

Reetta Kälviäinen, MD, PhD; Marja Äikiä, MA; Anna Maija Saukkonen, MD; Esa Mervaala, MD, PhD; Paavo J. Riekkinen, Sr, MD, PhD

Arch Neurol. 1995;52(10):989-996.

Abstract
Objective
To evaluate the efficacy, safety, and cognitive effects of initial vigabatrin monotherapy compared with initial carbamazepine monotherapy in patients with newly diagnosed epilepsy.

Design
Open, randomized, controlled design. Follow-up period of 12 months.

Setting
University hospital with an epilepsy center.

Patients
A total of 100 patients, aged 15 to 64 years, classified as suffering from partial seizures and/or generalized tonic-clonic seizures were randomized to either vigabatrin or carbamazepine monotherapy. Fifty-nine patients with a single epileptic seizure and no antiepileptic drug treatment served as a control population for objective safety measures.

Outcome Measures
To evaluate the comparative efficacy and toxicity of vigabatrin and carbamazepine, the drug success rate (ie, the proportion of patients continuing successful treatment with the randomly assigned drug) after 12 months of steady-state treatment was used. To evaluate the safety of the drugs in addition to reported side effects, visual evoked potential recordings and neuropsychological evaluation were performed during follow-up.

Results
During the 12-month follow-up period, 60% of patients receiving vigabatrin and carbamazepine were treated successfully. Vigabatrin caused fewer side effects that required discontinuation of therapy. However, vigabatrin had to be discontinuated more often owing to lack of efficacy, and fewer of the successfully treated patients receiving vigabatrin achieved total freedom from seizures. Vigabatrin had no detrimental effects on cognitive functions. Retrieval from both episodic and semantic memory and flexibility of mental processing improved significantly in patients successfully treated with vigabatrin.

Conclusion
Vigabatrin seems to be an effective and safe antiepileptic drug as primary monotherapy for epilepsy with fewer cognitive side effects than carbamazepine.

Author Affiliations
From the Departments of Neurology (Drs Kälviäinen and Saukkonen and Ms Äikiä) and Clinical Neurophysiology (Dr Mervaala), Kuopio (Finland) University Hospital, and the Department of Neurology and A. I. Virtanen Institute, University of Kuopio (Dr Riekkinen).

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