Gabapentin Versus Lamotrigine Monotherapy: A Double-Blind Comparison in Newly Diagnosed Epilepsy.
Abstract number :
2.235
Submission category :
Year :
2001
Submission ID :
1617
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
M.J. Brodie, MD, University of Glasgow, United Kingdom; D.W. Chadwick, MD, Walton Centre for Neurology and Neurosurgery, Liverpool, United Kingdom; H. Anhut, PhD, Parke-Davis Research and Development, Freiburg, Germany; A. Otte, MD, Parke-Davis Research a
RATIONALE: In this randomised, double-blind study the newer antiepileptic drugs (AEDs) gabapentin and lamotrigine were compared as monotherapy in newly diagnosed epilepsy.
METHODS: Patients with partial seizures with and/or without secondary generalization or primary generalized tonic-clonic seizures were randomized to treatment with either gabapentin or lamotrigine. Gabapentin dosage reached 1800 mg/day and lamotrigine 150 mg/day following 2 and 6 week fixed titration schedules respectively. In the subsequent 24 week maintenance phase, the dose could be adjusted based on seizure control or adverse events between 1200 - 3600 mg/day for gabapentin and 100 - 300 mg/day for lamotrigine. The primary endpoint was time to exit, a composite of efficacy and tolerability. Based on a proportional hazard model, a two-sided 90% confidence interval for the ratio gabapentin/lamotrigine of hazard rates was calculated. The evaluable patient population was used for the primary efficacy analysis, while tolerability was examined on an intent-to-treat basis.
RESULTS: From a total of 309 randomised patients 291 (148 gabapentin, 143 lamotrigine) were included in the evaluable population. Nineteen patients in each group experienced an exit event. For gabapentin, the median time to exit was 69 days and for lamotrigine it was 48 days. The hazard ratio was estimated as 1.043 (90% confidence intervals 0.602 to 1.809) showing that gabapentin and lamotrigine were statistically equivalent. Overall, 106 (71.6% of the evaluable population) gabapentin-treated and 96 (67.1%) lamotrigine-treated patients completed the study. Of those, 80 patients (75.5%) taking gabapentin and 73 (76.0%) on lamotrigine remained seizure-free during the final 12 weeks of treatment. Only 14 gabapentin-treated patients and 15 lamotrigine-treated patients withdrew due to adverse events.
CONCLUSIONS: Gabapentin and lamotrigine monotherapy were similarly effective and well tolerated in patients with newly diagnosed epilepsy.
Support: This study was funded by Parke-Davis Research and Development.
Disclosure: Salary - Four co-authors are employees of the study sponsor.