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Gabapentin Versus Vigabatrin as First Add‐On for Patients with Partial Seizures That Failed to Respond to Monotherapy: A Randomized, Double‐Blind, Dose Titration Study
Author(s) -
Lindberger Martin,
Alenius Martin,
Frisén Lars,
Johannessen Svein I.,
Larsson Sirkku,
Malmgren Kristina,
Torason Torbjorn
Publication year - 2000
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.2000.tb04607.x
Subject(s) - vigabatrin , medicine , randomization , randomized controlled trial , gabapentin , anesthesia , adverse effect , epilepsy , tolerability , partial seizures , anticonvulsant , surgery , psychiatry , alternative medicine , pathology
Summary Purpose: Our objective was to compare the efficacy and safety of gabapentin and vigabatrin as first‐line addon treatment in patients with partial epilepsy. Methods: This was a multicenter, double‐blind, randomized dose titration study. After baseline assessment and randomization, the dose could be increased if seizures persisted and reduced if side effects occurred. Health‐related quality of life was assessed at baseline and at the end of the study. By a protocol amendment post hoc, all randomized patients were offered a standardized perimetry examination at the end of the study. Improvement rate was the proportion of patients with a reduction of seizure frequency of at least 50% during an 8‐week period without any adverse events causing withdrawal. Results: One hundred two patients were randomized and analyzed on an intent‐to‐treat basis. The improvement rate was 48% in the gabapentin group and 56% in the vigabatrin group. The improvement rate, when per protocol criteria were fulfilled, was 57% in the gabapentin group and 59% in the vigabatrin group. The proportion of seizure‐free patients was 31 % in the gabapentin group and 39% in the vigabatrin group. There was no difference in quality‐of‐life scores between the groups. Perimetry after termination of the study on 64 patients showed abnormal results in 3 of 32 patients in the vigabatrin group. Conclusion: Approximately one third of the patients in both groups became seizure‐free. Although no major differences were seen in terms of the improvement rate between the groups, equivalence between the two drugs was not found.