Description:
<jats:title>Summary</jats:title><jats:sec><jats:title>Objective</jats:title><jats:p>To compare the effectiveness of controlled‐released carbamazepine (CR‐CBZ) to levetiracetam (LEV) and to lamotrigine (LTG) in elderly patients with newly diagnosed focal epilepsy.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Randomized, double‐blind, parallel‐group trial conducted between January 2007 and August 2011, in 47 ambulatory or hospital sites in Germany, Austria, or Switzerland. Eligible participants were aged ≥60, had new‐onset epilepsy, had no acute illness as the cause of their seizures, and had no contraindication to the drugs in the trial. Patients were randomized 1:1:1 to CR‐CBZ, LTG, or LEV. Doses were up‐titrated for 6 weeks and could be maintained or adjusted depending on seizure relapse or tolerability over an additional period of 52 weeks. Primary outcome was the retention to treatment at week 58; secondary measures related to seizure and adverse event frequency.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 361 randomized patients, 359 were included (CR‐CBZ n = 121, LTG n = 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 higher than for CR‐CBZ (61.5% vs. 45.8%, p = 0.02), and similar to LTG (55.6%). Seizure freedom rates at weeks 30 and 58 were not different across the groups. Twice as many patients receiving CR‐CBZ discontinued due to adverse events or death compared to those 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%). Median daily doses of completers (n = 195) were CR‐CBZ 380.0 mg/day (333.0–384.0), LTG 95 mg/day (94.0–97.0), and LEV 950 mg/day (940.0–985.0).</jats:p></jats:sec><jats:sec><jats:title>Significance</jats:title><jats:p>In the initial monotherapy of focal epilepsy in the elderly, 1‐year retention to LEV was higher compared to CR‐CBZ due to better tolerability. Retention of LTG was intermediate and close to LEV, but did not differ significantly from either comparators. NCT00438451, <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</jats:ext-link>.</jats:p></jats:sec>