1166 between groups; p = 0.9221 Group × Visit). Adverse Events Taking into consideration the first variable of safety, drop out for side effects, the Fisher exact test showed a significant difference between the OXC group and the Traditional AED group (p = 0.0090)(Odds ratio = 6.303). In particular, concerning
drop-out due to heavy side effects, only 3 patients in the OXC group and 13 patients of Traditional AEDs group were forced to stopped the AEDs. Taking into consideration the second variable of safety, total incidence of side effects, Fisher exact Ceritinib test showed a significant difference between the OXC group and the Traditional AED group (p = 0.0063)(Odds ratio = 5.813). In particular, four patients had side effects during OXC treatment whereas 15 patients in the Traditional AEDs group had side effects. Discussion Epilepsy is considered the most important risk factor
for long-term disability in brain tumour selleck chemicals patients [23]. Unfortunately, the side effects related to antiepileptic drugs can seriously affect the patients’ quality of life; in fact, it has been found that patients’ concerns with the AEDs’ side effects have often taken precedence over their desire to reduce seizure frequency [24]. Side effects are mostly associated with the administration of traditional, older AEDs [3–8]. The few studies which have been done on the newer AEDs indicate that these same side effects are less frequent with these drug [9–13]. To date, a comparative study of this type has not been done. We performed a statistical analysis and applied a Propensity Score in order to minimize the selection bias and other sources of bias. Concerning efficacy, results showed no major differences between the two groups. Concerning safety and tolerability, however, the profiles differ significantly. The traditional AED group had had more side effects than the OXC group (42.9% vs 11.4%), including heavy side effects which led patients to discontinue usage of the below AED. It is generally accepted that the percentage of patients withdrawing because of adverse effects represents a reliable marker of tolerability [25]. The percentage of side effects for
OXC was similar to that observed in non-tumoral, epileptic patients (10%)[19], and the percentage of side effects for traditional AEDs is consistent with literature data (5 to 38% in patients with brain tumor-related epilepsy)[3]. The most common side effects we found were rash (11.4% in Traditional AEDs group and 8.6% in OXC group) and psychomotor slowness (21.7% only in Traditional AEDs group). In epileptic, non-tumoral patients, rash is a common side effect associated with most AED use, ranging between 3–10% and has been the leading cause of withdrawal from some AED trials [6, 26]. The available data to date indicate that in patients with brain tumor-related epilepsy, the incidence of severe rash is higher than in non-tumoral, epileptic patients (14%)[3].