A comparison of pregabalin, lamotrigine, and placebo as adjunctive therapy in patients with refractory partial-onset seizures

作者：Baulac Michel^*; Leon Teresa; O'Brien Terence J; Whalen Edward; Barrett Jeannette

来源：Epilepsy Research, 2010, 91(1): 10-19.

DOI：10.1016/j.eplepsyres.2010.05.008

• Pregabalin
• Lamotrigine
• Placebo
• Antiepileptic drugs
• Randomized
• Seizures

Purpose: This study assessed the comparative efficacy of pregabalin for refractory partial seizures.
Methods: Four-hundred and thirty-four patients with partial seizures were randomized to pregabalin, lamotrigine, or placebo as adjunctive therapy for 17 weeks of double-blind treatment. In phase I (11 weeks), pregabalin was titrated over 1 week and lamotrigine over 5 weeks to fixed dosages of 300 mg/day for both. In phase II (6 weeks), patients not yet seizure-free were increased to pregabalin 600 mg/day or lamotrigine 400 mg/day.
Results: During phase I, there was a nonsignificant trend toward a greater reduction in seizures with pregabalin versus placebo and lamotrigine. Across the 17 weeks of treatment, pregabalin showed a median percentage reduction from baseline in seizure frequency of -20.0% (p = .001) versus placebo, and -9.7% (p = .080) versus lamotrigine. The responder rate (>= 50% reduction in seizure frequency) for pregabalin exceeded that of placebo (36% vs 21%; p = .007) and lamotrigine (36% vs 24%; p = .04). Adverse events were consistent with the known safety profiles of pregabalin and lamotrigine.
Discussion: Pregabalin was demonstrated to be noninferior to lamotrigine in the treatment of refractory partial seizures. Overall conclusions were complicated by an unusually large and heterogeneous placebo response.

• 出版日期2010-9