Abstracts

To compare the safety and tolerability of Levetiracetam (LEV) and Pregabalin (PGB) using one of two titration schedules (fast and slow) as add-on treatment in patients with refractory partial epilepsy on polytherapy while receiving 3 concurrent marketed AEDs., A total of 128 patients with refractory partial epilepsy receiving a stable regimen of two or three AEDs were randomized to LEV fast rate, LEV slow rate, PGB fast rate and PGB slow rata dosage adjustment (32 patients x 4 groups). LEV fast rate group was given LEV at a starting dosage of 1000 mg b.i.d with weekly increments of 500 mg. LEV slow rate group was given LEV at a starting dosage of 500 mg b.i.d with weekly increments of 250 mg. PGB fast rate group was given PGB at starting dosage of 300 mg b.i.d with weekly increments of 150 mg. PGB slow rate group was given PGB at starting dosage of 150 mg b.i.d with weekly increments of 75 mg. Primary parameters were rate of withdrawals and rate of continuation to 3000 mg b.i.d LEV and 600 mg b.i.d PGB maximum dosage while reducing previous polytherapeutic dosage., The incidence of adverse events was similar among LEV study groups (fast and slow rate dosage). With fast titration 2 out 32 (6.25%) and with slow titration 1 out 32 (3,12%) reported serious adverse events with discontinuation. In LEV groups 18 out 32 (56.25%) with fast titration and 20 out 32 (62.50%) with slow titration reached maximum LEV dosage (3000 mg b.i.d). These differences were not significant. Twelve patients reported side effects while taking PGB fast titration (37.5%) and only one (3.12%) with slow titration (P [lt] 0.01). In these PGB groups 6 out 32 (18.75%) with fast titration and 20 out 32 (62.5%) with slow titration reached maximum PGB dosage (600 mg b.i.d) while reducing previous polytherapeutic dosage (P [lt] 0.01)., Levetiracetam appears to be well tolerated with fast and slow dosage regimen. Pregabalin should be taken with a starting dose of 150 mg b.i.d with weekly increments of 75 mg dosage adjustment as adjunctive treatment in patients with refractory partial epilepsy on excessive polytherapy.,