Sharma Arvind, Korukonda Krishnaprasad, Haldar Amit, Misra Usha Kant, Anand R V, Dave Yakshdeep, Kulkarni Girish
Zydus Hospitals, Ahmedabad, Gujarat, India.
Medical Affairs, Torrent Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.
Epilepsia Open. 2025 Feb;10(1):134-142. doi: 10.1002/epi4.13065. Epub 2024 Nov 14.
Brivaracetam (BRV), a third-generation anti-seizure medication (ASM) offers strong conformational receptor domain binding, faster blood brain barrier (BBB) permeability and better tolerability making it potential therapeutic option as an initial line or initial line add-on strategy for focal onset seizure (FoS). The following study was planned to further understand the role and relevance of BRV in the real world settings of India.
This was a multicentric, cross-sectional, and non-interventional study conducted in patients with FoS across India. The study was approved by central independent ethics committee. Descriptive and analytical statistics employed using SPSS version 29.0.1.0.
Per protocol (PP) analysis included 8479 eligible patients from 1069 sites, gender; 5771 (68.06%) male and 2708 (31.94%) female with mean age 41.21 ± 12.74 years. Total 8019 (94.57%) patients had FoS and 460 (5.43%) patients had focal to bilateral tonic-clonic seizures (FBTCs). In FoS, 4105 (51.19%) patients switched from LEV to BRV whereas 3914 (48.81%) switched from other ASMs to BRV. BAEs accounted for 2059 (50.16%) patients in LEV to BRV switch versus 133 (3.39%) in other ASM to BRV switch. Post switch, LEV-associated BAEs reduced irrespective of being used as monotherapy 85.65% (p < 0.001) or as an adjuvant therapy 83.71% (p < 0.001) at BRV dosage of 50 to 100 mg BID. This RWE showed the utility of BRV as mono component as an initial add-on strategy in FoS cases.
BRV remains a pertinent therapeutic choice for FoS for the treatment naïve and/or BAE cases. Exposure of LEV leads to considerable BAEs compared to patients without LEV exposure. Patients who switched to BRV due to LEV-induced BAEs significantly improved tolerability with BRV irrespective being used as monotherapy or as adjuvant therapy.
Current study was planned to understand the clinical role and relevance of third-generation anti-seizure medication (ASM), brivaracetam (BRV) in the real world settings of India. Outcome of the study highlighted that BRV is an emerging, potential and safe ASM treatment option for epilepsy in Indian context. Many patients with epilepsy who are not able to tolerate the other ASM including levetiracetam (LEV) primarily due to behavioral side effects improves tolerability post switch to BRV, additionally results are consistent either BRV being used as an adjuvant therapy or as monotherapy therapy.
布瓦西坦（BRV）是一种第三代抗癫痫药物（ASM），具有强大的构象受体域结合能力、更快的血脑屏障（BBB）通透性和更好的耐受性，使其有可能作为局灶性发作（FoS）的一线或一线附加治疗策略。以下研究旨在进一步了解BRV在印度现实环境中的作用和相关性。
这是一项在印度各地对FoS患者进行的多中心、横断面、非干预性研究。该研究得到了中央独立伦理委员会的批准。使用SPSS 29.0.1.0进行描述性和分析性统计。
符合方案（PP）分析纳入了来自1069个地点的8479例合格患者，性别方面，5771例（68.06%）为男性，2708例（31.94%）为女性，平均年龄41.21±12.74岁。共有8019例（94.57%）患者为FoS，460例（5.43%）患者为局灶性继发全面强直阵挛发作（FBTCs）。在FoS中，4105例（51.19%）患者从左乙拉西坦（LEV）转换为BRV，而3914例（48.81%）患者从其他ASM转换为BRV。在从LEV转换为BRV的患者中，2059例（50.16%）出现不良事件（BAEs），而在从其他ASM转换为BRV的患者中，这一比例为133例（3.39%）。转换后，无论BRV剂量为50至100mg每日两次时作为单药治疗（85.65%，p<0.001）还是辅助治疗（83.71%，p<0.001），与LEV相关的BAEs均减少。这项真实世界证据显示了BRV作为单一组分在FoS病例中作为初始附加治疗策略的效用。
BRV仍然是初治和/或BAE病例FoS的相关治疗选择。与未接触LEV的患者相比，接触LEV会导致相当多的BAEs。因LEV诱导的BAEs而转换为BRV的患者，无论BRV作为单药治疗还是辅助治疗，耐受性均显著提高。
当前研究旨在了解第三代抗癫痫药物（ASM）布瓦西坦（BRV）在印度现实环境中的临床作用和相关性。研究结果强调，在印度背景下，BRV是一种新兴、有潜力且安全的ASM癫痫治疗选择。许多主要因行为副作用而无法耐受包括左乙拉西坦（LEV）在内的其他ASM的癫痫患者，转换为BRV后耐受性提高，此外，无论BRV用作辅助治疗还是单药治疗，结果都是一致的。
