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.

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, α=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.

CLINICAL TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov identifier NCT00242606.

• Authors: Felix Rosenow, Carmen Schade-Brittinger, Nicole Burchardi, Sebastian Bauer, Karl Martin Klein, Yvonne Weber, Holger Lerche, Stefan Evers, Stjepana Kovac, Susanne Hallmeyer-Elgner, Götz Winkler, Joachim Springub, Mathias Niedhammer, Erhard Roth, Ilonka Eisensehr, Jörg Berrouschot, Stephan Arnold, Michael Schröder, Anja Beige, Wolfgang H Oertel, Adam Strzelczyk, Anja Haag, Philipp S Reif, Hajo M Hamer, LaLiMo Study Group
• Journal: Journal of neurology, neurosurgery, and psychiatry (J Neurol Neurosurg Psychiatry) Vol. 83 Issue 11 Pg. 1093-8 (Nov 2012) ISSN: 1468-330X [Electronic] England
• PMID: 22595362 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticonvulsants
• Triazines
• Levetiracetam
• Lamotrigine
• Piracetam

Topics

• Adolescent
• Adult
• Anticonvulsants (adverse effects, therapeutic use)
• Child
• Early Diagnosis
• Epilepsy (drug therapy)
• Female
• Humans
• Lamotrigine
• Levetiracetam
• Male
• Middle Aged
• Piracetam (adverse effects, analogs & derivatives, therapeutic use)
• Quality of Life
• Triazines (adverse effects, therapeutic use)