期刊
EPILEPSY RESEARCH
卷 82, 期 1, 页码 86-92出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.eplepsyres.2008.07.004
关键词
Pregabalin; Secondarily generalized tonic-clonic; Seizure reduction; Placebo-controlled study; Refractory partial epilepsy
资金
- Pfizer Inc
Purpose: To determine whether pregabalin reduces SGTC seizures in clinically refractory epilepsy. Methods: Design: Post hoc analysis performed on pooled data from three double-blind, placebo-controlled trials of similar design. Participants: Patients with partial seizures who failed >= 2 antiepileptic drugs at maximally tolerated doses. This analysis excluded those who did not have an SGTC seizure during baseline or treatment periods. Outcome measure: Absolute and conditional reduction analyses examined change from baseline in SGTC seizure rates. The absolute reduction analysis used response ratio (RRatio) to compare reduction in seizure-frequency from baseline (8) during a 12-week treatment (T) period [RRatio = ((T-B)I(T+B)) x 100]. The conditional analysis examined proportional risk of having SGTC seizure if a partial seizure had occurred. Results: Of 1052 intent-to-treat patients, 409 were included. Sixteen were seizure-free during treatment and not included in the conditional analysis. A significant reduction in absolute SGTC seizures from baseline was observed in patients receiving pregabalin 600 mg/day (treatment RRatio, -33 versus placebo, -3.7; P = 0.0005). A lower dose of pregabalin (300 mg/day), administered in one study, demonstrated a trend (nonsignificant) toward reduced SGTC seizures (treatment, -24.7 versus placebo, -10.0; P = 0.2493). Conclusion: As adjunctive therapy, pregabalin 600 mg/day is effective in reducing the absolute frequency of SGTC seizures in patients with refractory partial epilepsy, but not secondary generalization. (C) 2008 Elsevier B.V. All rights reserved.
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