Effectiveness and safety of perampanel as early add-on treatment in patients with epilepsy and focal seizures in the routine clinical practice: Spain prospective study (PERADON)

Effectiveness and safety of perampanel monotherapy for focal and generalized tonic‐clonic seizures: Experience from a national multicenter registry

“…Our retention rates are similar to those observed in the study by Gil-Nagel et al, 10 with retention rates of 95% and 74% at 3 and 6 months, respectively. The outcomes presented here are in line with a study of PER as early add-on treatment in patients with focal epilepsy (retention rate of 80.5% at 12 months) 11 and with another study in patients with IGE (retention rate of 83% at 12 months). 12 On the other hand, our data are more optimistic than other observational studies in routine clinical use (retention rates of 48%-60% at 12 months), [16][17][18][19][20][21][22][23] where PER was added to the treatment of patients with focal epilepsy who had a higher degree of refractoriness as revealed by a greater number of previous AEDs, a higher frequency of seizures during the baseline period, and a larger median dose of PER than in our population.…”

“…As expected from extrapolation of results of regulatory and open-label extension trials, [2][3][4][5]26 in our population, PER was also efficacious in patients with GTCS, with 78% and 55% of patients rendered seizure-free at 6 and 12 months, respectively. The good response we observed in this study is in line with other observational studies where PER was considered as an early add-on (responder rates of 50% and 68% at 6-12 months), 11 stressing that patients with less resistant epilepsy could benefit from PER at low doses, as shown in this study. Besides this, when considering conversion to monotherapy, caution needs to be taken, because some patients could potentially experience a seizure increase due to the discontinuation of concomitant AEDs.…”

“…12,16,17,19,21,27 Additionally, we did not observe a higher risk of TEAEs among older patients. When compared with other observational studies where PER was considered as an early add-on or as conversion to monotherapy, the higher rate of TEAEs observed in our study (45.9% vs 20%-41.5%) [10][11][12] could be explained by a longer follow-up; supporting this is the finding that the discontinuation rate in the first 12 month of follow-up due to TEAEs was similar to those studies (10% vs 7%-15.9%). [10][11][12] We did not observe any unknown AEs not reported in previous studies, and most of the TEAEs were considered mild and, therefore, did not change substantially the treatment schedule with PER.…”

“…In this regard, a previous European study, 10 with a smaller number of patients and a shorter follow-up, has shown that monotherapy with PER was feasible. Two postmarketing studies 11,12 have already shown that monotherapy with PER could be reached through conversion to monotherapy in up to 4% of patients with either focal seizures or IGE. Additionally, a subanalysis of the open-label extension studies 13 showed that a small proportion of patients with drug-resistant epilepsy were successfully converted to monotherapy.…”

“…and retrospective studies [10][11][12][13] have reported preliminary experiences with a limited number of patients receiving PER as monotherapy, who were followed for a short period of time. Besides this, data from these studies focused principally on patients who received PER after conversion to monotherapy, as very few patients were initially treated with PER monotherapy.…”