@article {Trinka1138, author = {Eugen Trinka and Anthony G Marson and Wim Van Paesschen and Reetta K{\"a}lvi{\"a}inen and Jacqueline Marovac and Benjamin Duncan and Sonja Buyle and Yngve Hallstr{\"o}m and Petr Hon and Gian Carlo Muscas and Mark Newton and Heinz-Joachim Meencke and Philip E Smith and Bernd Pohlmann-Eden and for the KOMET Study Group}, title = {KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy}, volume = {84}, number = {10}, pages = {1138--1147}, year = {2013}, doi = {10.1136/jnnp-2011-300376}, publisher = {BMJ Publishing Group Ltd}, abstract = {Objective To compare the effectiveness of levetiracetam (LEV) with extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients with newly diagnosed epilepsy. Methods This unblinded, randomised, 52-week superiority trial (NCT00175903) recruited patients (>=16 years of age) with >=2 unprovoked seizures in the previous 2 years and >=1 in the previous 6 months. The physician chose VPA or CBZ as preferred standard treatment; each patient was randomised to standard treatment or LEV. The primary outcome was time to treatment withdrawal (LEV vs standard antiepileptic drugs (AEDs)). Analyses also compared LEV with VPA-ER, and LEV with CBZ-CR. Findings 1688 patients (mean age 41 years; 44\% female) were randomised to LEV (n=841) or standard AEDs (n=847). Time to treatment withdrawal was not significantly different between LEV and standard AEDs: HR (95\% CI) 0.90 (0.74 to 1.08). Time to treatment withdrawal (HR (95\% CI)) was 1.02 (0.74 to 1.41) for LEV/VPA-ER and 0.84 (0.66 to 1.07) for LEV/CBZ-CR. Time to first seizure (HR, 95\% CI) was significantly longer for standard AEDs, 1.20 (1.03 to 1.39), being 1.19 (0.93 to 1.54) for LEV/VPA-ER and 1.20 (0.99 to 1.46) for LEV/CBZ-CR. Estimated 12-month seizure freedom rates from randomisation: 58.7\% LEV versus 64.5\% VPA-ER; 50.5\% LEV versus 56.7\% CBZ-CR. Similar proportions of patients within each stratum reported at least one adverse event: 66.1\% LEV versus 62.0\% VPA-ER; 73.4\% LEV versus 72.5\% CBZ-CR. Conclusions LEV monotherapy was not superior to standard AEDs for the global outcome, namely time to treatment withdrawal, in patients with newly diagnosed focal or generalised seizures.}, issn = {0022-3050}, URL = {https://jnnp.bmj.com/content/84/10/1138}, eprint = {https://jnnp.bmj.com/content/84/10/1138.full.pdf}, journal = {Journal of Neurology, Neurosurgery \& Psychiatry} }