PT -期刊文章盟特伦斯j . O ' brien AU -弗朗西斯科·Bibbiani盟安娜彭定康AU -安东尼奥Laurenza AU -贝特西·威廉姆斯TI -效应共同相伴的抗癫痫药物(aed)辅助治疗期间Perampanel:事后分析的非盲扩展(OLEx)第三阶段研究特发性全身性癫痫患者(IGE) (P1.261) DP - 2018年4月10 TA -神经病学PG - P1.261 VI - 90 IP - 15补充4099 - //www.ez-admanager.com/content/90/15_Supplement/P1.261.short 4100 - //www.ez-admanager.com/content/90/15_Supplement/P1.261.full所以Neurology2018 4月10;首页90 AB -目的:评估的影响最常见的伴随的基线aed停药率和治疗诱发不良事件(TEAE)在治疗辅助perampanel发生率。背景:Perampanel、选择性、非竞争性AMPA受体拮抗剂,被批准用于治疗局部癫痫,有/没有其次广义癫痫,辅助治疗的原发性广义tonic-clonic (PGTC)癫痫患者癫痫≥12岁。这事后分析评估的影响最常见的伴随的基线aed停药率和TEAE发病率与perampanel辅助治疗期间患者(≥12岁)PGTC发作和IGE OLEx阶段研究332 (NCT02307578)。设计/方法:患者完成双盲研究可以得到perampanel(≤12毫克/天)在OLEx(六周蒙蔽转换时期;≤136周的维护)。在这里,我们报告结果perampanel在4 - 8毫克/天,在8 - 12毫克/天。结果:最常见的伴随的基线aed丙戊酸(N = 55)、拉莫三嗪(N = 53), levetiracetam (N = 37),托吡酯(N = 21),和zonisamide (N = 12);病人可能已经收到了在1的这些基线aed。中断的最常见的原因是:不良事件(s) (AE),“其他”,和病人的选择。拉莫三嗪:病人选择,N = 6/34(在4 - 8毫克/天); 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. O'Brien 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. O'Brien 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.
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