6533b82dfe1ef96bd12914c8

RESEARCH PRODUCT

A randomized, double-blind comparison of antiepileptic drug treatment in the elderly with new-onset focal epilepsy.

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Objective: To compare the effectiveness of controlled-released carbamazepine (CR-CBZ) to levetiracetam (LEV) and to lamotrigine (LTG) in elderly patients with newlydiagnosedfocalepilepsy.Methods: Randomized, double-blind, parallel-group trial conducted between January2007andAugust2011,in47ambulatoryorhospitalsitesinGermany,Austria,orSwit-zerland. Eligible participants were aged ≥60, had new-onset epilepsy, had no acute ill-nessasthecauseoftheirseizures,andhadnocontraindicationtothedrugsinthetrial.Patients were randomized 1:1:1 to CR-CBZ, LTG, or LEV. Doses were up-titrated for6 weeks and could be maintained or adjusted depending on seizure relapse or tolera-bility over an additional period of 52 weeks. Primary outcome was the retention totreatment at week 58; secondary measures related to seizure and adverse event fre-quency.Results: Of 361 randomized patients, 359 were included (CR-CBZ n = 121, LTGn = 117, LEV n = 122) in the modified intent-to-treat population (mean age [range]71.4 [60–95] years). At week 58, the retention rate for LEV was significantly higherthan for CR-CBZ (61.5% vs. 45.8%, p = 0.02), and similar to LTG (55.6%). Seizure free-dom rates at weeks 30 and 58 were not different across the groups. Twice as manypatients receiving CR-CBZ discontinued due to adverse events or death compared tothose in the LEV group (32.2% vs. 17.2%; odds ratio 2.28, 95% confidence interval [CI]1.25–4.19, p = 0.007), whereas discontinuation was intermediate for LTG (26.3%).Mediandailydosesofcompleters(n = 195)wereCR-CBZ380.0 mg/day(333.0–384.0),LTG95 mg/day(94.0–97.0),andLEV950 mg/day(940.0–985.0).Significance: In the initial monotherapy of focal epilepsy in the elderly, 1-year reten-tion to LEV was higher compared to CR-CBZ due to better tolerability. Retention ofLTG was intermediate and close to LEV, but did not differ significantly from eithercomparators.NCT00438451,www.clinicaltrials.gov.KEY WORDS: Elderly, Monotherapy, Antiepileptic drugs, Levetiracetam, Carbamaz-epine.