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Seizure‐free Days Observed in Randomized Placebo‐controlled Add‐on Trials with Levetiracetam in Partial Epilepsy

2003; Wiley; Volume: 44; Issue: 10 Linguagem: Inglês

10.1046/j.1528-1157.2003.62802.x

1528-1167

Ilo E. Leppik, Martha J. Morrell, Philippe Godfroid, C. Arrigo,

Drug Transport and Resistance Mechanisms

Summary: Purpose: We examined the effect of adjunctive levetiracetam (LEV; 1,000 to 3,000 mg/day) on the number of seizure‐free days gained per quarter in adult patients with refractory partial‐onset epilepsy. Methods: The treatment effect was studied in a meta‐analysis using individual patient data of a subpopulation of patients (n = 846) emerging from the three randomized, double‐blind, placebo‐controlled, phase III trials (n = 904). Results: Adding LEV effectively increased the number of days without seizures by 5.19 days per quarter [95% confidence interval (CI), 3.63–6.76; p = 0.0001 ; titration and stable dose periods] . Conclusions: LEV adjunctive treatment shows a clear benefit in terms of seizure‐free days gained for patients with refractory epilepsy. This gain is significant for the pooled and for each LEV dose compared with placebo.