Long-Term Efficacy and Safety of Pregabalin for the Treatment of Partial Onset Seizures
Abstract number :
2.258
Submission category :
Year :
2001
Submission ID :
2845
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
D.N. Minecan, MD, Neurology, University of Michigan Hospitals, Ann Arbor, MI; E.A. Passaro, MD, Neurology, University of Michigan Hospitals, Ann Arbor, MI; P. Murugaiyan, MD, Neurology, University of Michigan Hospitals, Ann Arbor, MI; C.J. Milling, MD, Ne
RATIONALE: Pregabalin, an analog of gamma aminobutyric acid, demonstrated significant efficacy as adjunctive therapy for medically refractory partial epilepsy in two large randomized, multicenter, placebo-controlled clinical trials. In this study, we evaluated the longer-term efficacy and safety of add-on therapy with pregabalin for the treatment of partial onset seizures.
METHODS: Data from patients evaluated at the University of Michigan and who completed at least 8 months of the open-label phase (OLP) of the double-blind, multicenter, placebo-controlled clinical trial were analyzed. Study seizures were defined as complex partial or secondarily generalized tonic-clonic seizures. Pregabalin was titrated to a maximum daily dose of 600 mg, taken on a TID schedule. The 4-week study seizure frequency (SSF) during the first and last 8-week baseline obtained prior to the double-blind phase. statistical significance was set at p values [lt]0.5.
RESULTS: Sixteen patients (M=9; F=7) with a mean age of 42 years (range 20-54) participated in the OLP of the trial. There were significant reductions in the 4-week SSF during the first and last 8 weeks of the OLP compared to baseline. The SSF, which averaged 7.9 (1.5-41) at baseline, was reduced to 4.5 (1.0-16.7) during the first 8 weeks and to 3.8 (1.6-9.9) during the last 8 weeks of the OLP. This corresponded to a mean reduction of 47% and 51% during the first and last 8 weeks of the OLP, respectively. The responder rate was 44% and 38% during the first and last 8 weeks of the OLP, respectively. There was no significant difference in the SSF between the first and last 8 weeks of the OLP. The most common adverse effects were dizziness, somnolence and ataxia; they were usually transient and rated as mild or moderate in intensity.
CONCLUSIONS: Pregabalin has significant efficacy as adjunctive therapy for the treatment of seizures of partial onset. It is usually well tolerated and its efficacy is maintained over at least 8 months of treatment.
Support: Pfizer
Disclosure: Grant - Pfizer. Honoraria - Pfizer.