Rosenow, Felix and Schade-Brittinger, Carmen and Burchardi, Nicole and Bauer, Sebastian and Klein, Karl Martin and Weber, Yvonne and Lerche, Holger and Evers, Stefan and Kovac, Stjepana and Hallmeyer-Elgner, Susanne and Winkler, Goetz and Springub, Joachim and Niedhammer, Mathias and Roth, Erhard and Eisensehr, Ilonka and Berrouschot, Joerg and Arnold, Stephan and Schroeder, Michael and Beige, Anja and Oertel, Wolfgang H. and Strzelczyk, Adam and Haag, Anja and Reif, Philipp S. and Hamer, Hajo M. (2012) The LaLiMo Trial: lamotrigine compared with levetiracetam in the initial 26 weeks of monotherapy for focal and generalised epilepsy-an open-label, prospective, randomised controlled multicenter study. JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, 83 (11). pp. 1093-1098. ISSN 0022-3050, 1468-330X
Full text not available from this repository. (Request a copy)Abstract
Background Of the newer antiepileptic drugs, lamotrigine (LTG) and levetiracetam (LEV) are popular first choice drugs for epilepsy. The authors compared these drugs with regard to their efficacy and tolerability in the initial monotherapy for epilepsy. Methods A randomised, open-label, controlled, parallel group, multicenter trial was conducted to test the superiority of the LEV arm over the LTG arm. The primary endpoint was the rate of seizure-free patients in the first 6 weeks (two-sided Fisher's exact test, alpha.=0.05, intent-to-treat set). Furthermore, efficacy, tolerability and quality of life were evaluated. The authors included 409 patients aged >= 12 years with newly diagnosed focal or generalised epilepsy defined by either two or more unprovoked seizures or one first seizure with high risk for recurrence. Patients were titrated to 2000 mg/day of LEV or 200 mg/day of LTG reached on day 22 or 71, respectively. Two dose adjustments by 500/50 mg were allowed. Results The proportions of seizure-free patients were 67.5% (LEV) versus 64.0% (LTG) 6 weeks after randomisation (p=0.47), and 45.2% (LEV) versus 47.8% (LTG) during the whole treatment period of 26 weeks. The HR (LEV vs LTG) for seizure-free time was 0.86 (95% CI, 0.61 to 1.22). Adverse events occurred in 74.5% (LEV) versus 70.6% (LTG) of the patients (p=0.38). Adverse events associated with study discontinuation occurred in 17/204 (LEV) versus 8/201 (LTG) patients (p=0.07). Conclusions There were no significant differences with regard to efficacy and tolerability of LEV and LTG in newly diagnosed focal and generalised epilepsy despite more rapid titration in the LEV arm.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NEWLY-DIAGNOSED EPILEPSY; QUALITY-OF-LIFE; DOUBLE-BLIND; ANTIEPILEPTIC DRUGS; SEIZURE RECURRENCE; CARBAMAZEPINE; RISK; TOPIRAMATE; GABAPENTIN; VALPROATE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 May 2020 12:42 |
| Last Modified: | 04 May 2020 12:42 |
| URI: | https://pred.uni-regensburg.de/id/eprint/17902 |
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