Abstract | PURPOSE: 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 > or =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 (B) during a 12-week treatment (T) period [RRatio=((T-B)/(T+B))x100]. 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 (300mg/day), administered in one study, demonstrated a trend (nonsignificant) toward reduced SGTC seizures (treatment, -24.7 versus placebo, -10.0; P=0.2493). CONCLUSION:
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Authors | Deborah E Briggs, Caroline M Lee, Katharyn Spiegel, Jacqueline A French |
Journal | Epilepsy research
(Epilepsy Res)
Vol. 82
Issue 1
Pg. 86-92
(Nov 2008)
ISSN: 1872-6844 [Electronic] Netherlands |
PMID | 18752932
(Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Pregabalin
- gamma-Aminobutyric Acid
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Topics |
- Anticonvulsants
(administration & dosage, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Resistance, Multiple
- Epilepsies, Partial
(complications, drug therapy)
- Humans
- Multicenter Studies as Topic
(statistics & numerical data)
- Pregabalin
- Randomized Controlled Trials as Topic
(statistics & numerical data)
- Salvage Therapy
- Seizures
(etiology, prevention & control)
- gamma-Aminobutyric Acid
(administration & dosage, analogs & derivatives, therapeutic use)
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