Safety and efficacy of rapidly i.v. titrated levetiracetam versus valproate in patients with partial epilepsy

The objective of this prospective, randomized, open-label study was to compare safety and efficacy of rapid titration of levetiracetam (LEV) versus valproate (VPA) (bid for 2 days) in patients with epilepsy or following an epileptic seizure.

Method: A total of 61 patients (ages: 18–82 y; mean: 53 y; men: 35; women: 26) with diagnosed partial epilepsy or after a first seizure were included. Whereas 32 patients received 30mg/kg/d of LEV (min: 1400mg/d; max 3000mg/d, mean: 2218.4±394.4mg/d); 29 patients received 30mg/kg/d VPA (min: 1000mg/d; max: 2500mg/d; mean: 1696.6±353mg/d). The infusion time was 30 minutes. After 2 days patients were changed to oral LEV or VPA.

Results: The rapid up-titration to maintenance dose within 2 days was well tolerated in both groups. Whereas 10 AE were observed in 29 patients treated with VPA, 11 AE were observed in 32 patients receiving LEV. No serious AE occurred in either group. Two patients receiving VPA and 1 receiving LEV terminated the study prematurely. Seizure recurrence of at least one seizure between day 3 and 14 (final visit) of treatment tended to be lower in the LEV-group (9.4% LEV vs. 24.1% VPA) but did not gain statistical significance (p=0.17).

In conclusion, rapid titration of LEV or VPA to maintenance dose within 2 days is equally safe and effective