Abstracts

Rationale: The elderly population is the most rapidly growing segment in more developed countries and incidence of epilepsy is increasing at older ages. The number of elderly patients with epilepsy included in lacosamide (LCM) pivotal trials was limited due to upper age limits in inclusion criteria and complementary data in elderly would be most informative for clinical practice. Therefore, a subgroup analysis on the elderly was performed on data from the VITOBA study (SP0973, NCT01098162), evaluating the efficacy and tolerability of LCM in adult patients with partial-onset seizures receiving only one baseline AED in a real life medical practice setting. Methods: This 6-month non-interventional study was conducted in Germany. Outcome variables included seizure freedom and reduction in seizure frequency (≥50% and ≥75% responder rates) during the final 3 months of the study compared with 3-month retrospective baseline, as well as treatment-emergent adverse events (TEAEs). The elderly subgroup (≥65 years) was compared with younger patients (<65 years) from the same study dataset. All subgroup analyses are descriptive. Results: Of 571 patients evaluable for safety (SS), 110 (19.3%) were elderly (≥65 years), and 92/499 (18.4%) treated with in-label doses at any time and evaluable for seizure control (mFAS) were elderly. Baseline median seizure frequency per 28 days tended to be lower in the elderly than in younger patients (2.00 vs 2.33). The most frequently used baseline AEDs in elderly vs younger patients were levetiracetam (42.4% vs 31.2%) and lamotrigine (16.3% vs 25.3%) (mFAS). Elderly patients tended to have a more recent diagnosis, with 62.0% vs 35.1% having less than 5 years duration of epilepsy and 55.4% vs 34.2% having tried only 1 lifetime AED. More elderly patients reported any type of medical history at baseline (96.4% vs 76.8%). During the final 3 months of the study, more elderly patients were seizure free (56.7% vs 43.1%) or were ≥50% responders (81.1% vs 70.5%) (mFAS). Outcomes were numerically higher for both age subgroups when LCM was initiated after the first monotherapy, with 90.2% responder rate and 68.6% seizure freedom in the elderly vs 79.1% and 57.6% in the younger (Figure 1). For elderly vs younger, the reporting rates for any TEAE (45.5% vs 49.2%) and for TEAEs leading to discontinuation (8.2% vs 11.3%) were similar. Serious adverse events (SAEs) were reported in 15.5% of elderly vs 8.5% of younger, the minority of which (2.7% and 1.7%) considered related to LCM. Conclusions: Elderly patients tended to have higher efficacy outcomes and more recent diagnosis of epilepsy vs the younger population. Efficacy outcomes in both subgroups tended to be higher when LCM was used as a first add-on treatment. The frequency of TEAEs and the number of related SAEs were similar between elderly and younger patients and the AE pattern did not reveal a specific safety pattern in the elderly, although the elderly tend to report more non-related SAEs. Funded by UCB Pharma