Real world observational study investigating clinical effectiveness and safety of lacosamide in epilepsy: ULTIMATE...

Primary generalized tonic-clonic seizures (pGTCS) are often misdiagnosed and remain challenging to manage due to limited treatment options. Lacosamide (LCM), approved for focal-onset seizures and adjunctive pGTCS therapy, was evaluated for real-world effectiveness in Indian patients.

This real-world, multicenter, retrospective, observational, and non-interventional study was conducted across 124 centers in India following approval from a centralized institutional ethics committee. Data were analysed using descriptive and analytical statistical methods for continuous and categorical variables, utilizing SPSS version 29.0.1.0.

The Full Analysis Set (FAS) included 685 patients (245 females, 35.77 %; 440 males, 64.23 %) with a mean age of 43.30 ± 11.87 years. Among them, 301 (43.94 %) had pGTCS and 384 (56.06 %) had FoS. Concomitant ASMs for pGTCS included LEV (68.44 %), VPA (21.93 %), and CBZ (13.62 %), while for FoS, LEV (47.14 %) was most common, followed by VPA (16.15 %) and CBZ (14.58 %). At week 12, mean seizure frequency in pGTCS reduced from 3 to 1 (p < 0.0001), with 52.16 % achieving seizure freedom and a 66.78 % responder rate. LCM with LEV showed a two-fold higher responder rate than with other ASMs (OR: 2.3582, p = 0.0037). In FoS, 47.66 % achieved seizure freedom, with a 58.85 % responder rate. Moreover, when prescribed as monotherapy in FoS, LCM showed a 62.96 % responder rate. LCM was generally well tolerated across both groups, with no unexpected safety concerns observed during the study period.

This study demonstrated the effectiveness of LCM therapy in reducing seizure frequency and improving seizure control in Indian patients with epilepsy. LCM was well tolerated and remains potential therapeutic option either as monotherapy or as an adjuvant therapy in the management of FoS.