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• W2885504539 abstract "Objective: Assess the effects of the most common concomitant Baseline AEDs on discontinuation rates and treatment-emergent adverse event (TEAE) incidence during adjunctive perampanel treatment. Background: Perampanel, a selective, non-competitive AMPA receptor antagonist, is approved for treatment of partial seizures, with/without secondarily generalized seizures, and for adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy aged ≥12 years. This post hoc analysis assessed the effects of the most common concomitant Baseline AEDs on discontinuation rates and TEAE incidence during adjunctive treatment with perampanel in patients (aged ≥12 years) with PGTC seizures and IGE in the OLEx Phase of Study 332 (NCT02307578). Design/Methods: Patients completing the double-blind study could receive perampanel (≤12 mg/day) during the OLEx (6-week blinded Conversion Period; ≤136 weeks’ Maintenance). Here, we report results for perampanel >4–8 mg/day and >8–12 mg/day. Results: Most common concomitant Baseline AEDs were valproic acid (N=55), lamotrigine (N=53), levetiracetam (N=37), topiramate (N=21), and zonisamide (N=12); patients may have received >1 of these Baseline AEDs. The most common reasons for discontinuing were: adverse event(s) (AE), “other”, and patient choice. Lamotrigine: patient choice, N=6/34 (>4–8 mg/day); AE/”other”, both N=3/19 (>8–12 mg/day). Levetiracetam: patient choice, N=5/27 (>4–8 mg/day); AE, N=2/10 (>8–12 mg/day). Topiramate: “other”, N=3/15 (>4–8 mg/day); AE/”other”, both N=1/6 (>8–12 mg/day). Valproic acid: patient choice, N=6/38 (>4–8 mg/day); “other”, N=4/17 (>8–12 mg/day). Zonisamide: patient choice/”other”, both N=2/10 (>4–8 mg/day); no discontinuations (>8–12 mg/day). Patient-reported TEAEs ranged from: 88.2% (lamotrigine) to 93.3% (topiramate) for perampanel >4–8 mg/day; and 70.6% (valproic acid) to 100.0% (topiramate and zonisamide) for perampanel >8–12 mg/day. The most common TEAE was dizziness. Conclusions: In this post hoc analysis, primary reasons for discontinuation and TEAE incidence differed between the most common Baseline AED subgroups and perampanel dose range, although TEAE types were similar. These data provide additional information on the safety of adjunctive perampanel in patients with IGE. Study Supported by: Eisai Inc. Disclosure: Dr. O9Brien has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Speaking and advisory board fees for Jansen-Cilag, Eisai, and UCB. Dr. O9Brien has received research support from Research funding to my institution from Eisai, UCB, Janssen, and Lilly. Dr. Bibbiani has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai employee. Dr. Patten has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai Ltd. Dr. Laurenza has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai employee. Dr. Williams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Williams holds stock and/or stock options in Spouse is employee of Stryker Orthopedics. Dr. Williams has received research support from Employee of Eisai Inc." @default.
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• W2885504539 date "2018-04-10" @default.
• W2885504539 modified "2023-09-26" @default.
• W2885504539 title "Effect of Common Concomitant Antiepileptic Drugs (AEDs) During Adjunctive Treatment with Perampanel: Post Hoc Analysis from the Open-Label Extension (OLEx) of a Phase III Study in Patients with Idiopathic Generalized Epilepsy (IGE) (P1.261)" @default.
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