Abstracts

Pregabalin is approved in the US, EU, and elsewhere as adjunct therapy[mdash]at dosages of 150 to 600 mg/d^1-4[mdash]for adult patients with partial-onset seizures. We evaluated the efficacy, safety, and tolerability of pregabalin 300 mg/d as treatment of partial seizures by combining data from the 2 randomized clinical trials (RCTs) of pregabalin for this indication that included 300-mg/d fixed-dosage arms., The 2 RCTs shared a similar parallel-group design, with add-on treatment administered over 11 weeks. A total of 242 patients received pregabalin 300 mg/d, and 240 received placebo (PBO). All participating patients were [ge]12 years of age and refractory to treatment, ie, they had a history of failing two or more AEDs, and their seizures were inadequately controlled despite receiving 1 to 3 marketed AEDs concurrently. The primary efficacy measure was reduction in seizure frequency compared with baseline. Treatment efficacy was also evaluated by measuring the responder rate, ie, patients who experienced seizure reductions [ge]50% during treatment versus baseline., The pregabalin 300 mg/d treatment group demonstrated a significant reduction in seizure frequency relative to the PBO group: the treatment difference between pregabalin and placebo in mean seizure reduction was [ndash]34.8 ([italic]P[/italic][lt].0001). Overall, 36% of patients receiving 300 mg/d pregabalin were responders compared with 20% of patients receiving PBO ([italic]P[/italic][lt].05). Adverse events (AEs) associated with 300 mg/d pregabalin treatment were typically mild to moderate in intensity and tended to resolve with treatment. AEs, such as dizziness (14% of patients receiving 300 mg/d pregabalin and 4.6% of patients receiving PBO), somnolence (7.4% and 5%), and weight gain (3.7% and 0%), were evaluated., Pregabalin 300 mg/d was efficacious and generally well-tolerated as add-on therapy for partial seizures. At this 300 mg/d dosage, 36% of patients were responders ([ge]50% reduction in seizures) to pregabalin treatment. However, as previously reported (including a responder rate up to 51%¹), some patients may require, and tolerate well, increased dosages of up to 600 mg/d.
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