Table 1 Summary of most relevant clinical trials using levetiracetam (LEV) demonstrating both efficacies and tolerability in epilepsy
Authors and year | Total no. of patients/ no. given LEV | Dose (mg/day) | Impact of LEV on seizure frequency | Significant adverse events |
|---|---|---|---|---|
Ben-Menachem and Falter, 2000 [11] | 286/181 | 3000 | Significant benefit of LEV vs. placebo both as add-on (p < 0.001) and as subsequent monotherapy (p = 0.037) | Incidence of adverse events similar in placebo and treatment groups |
Betts et al., 2000 [12] | 119/80 | 2000 or 4000 | Significant benefit of LEV vs. placebo at 2000 mg per day (p < 0.05) | Somnolence, asthenia |
Cereghino et al., 2000 [13] | 294/199 | 1000 or 3000 | Significant benefit of LEV vs. placebo (50% responder rate p < 0.001) | Somnolence, asthenia, infection e.g. rhinitis |
Ferrendelli et al., 2003 [14] | 78 /78 (patients older than 65 years) | 1000 to 3000 | Subset analysis of patients who participated in the open label KEEPER trial of a total of 1030 patients.50% responder rate of 76.9% | Somnolence, asthenia Medication well-tolerated in older patients |
Shorvon et al., 2000 [15] | 324/212 | 1000 or 2000 | Significant benefit of LEV vs. placebo | No difference in adverse effects vs. placebo. Main side effects: somnolence, asthenia |
Cochrane review (meta-analysis 11 trials incl. above), 2012 [16] | 1861 (1565 adults) | 1000–4000 | Significant benefit to seizures from LEV at every dose compared to placebo Improved cognitive outcomes in adults | Somnolence (RR 1.51; 99% CI 1.06 to 2.17) Infection (RR 1.76; 99% CI 1.03 to 3.02) |