Center for Rare Neurological Diseases, Norcross, Georgia.
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Pediatr Neurol. 2022 Jul;132:50-55. doi: 10.1016/j.pediatrneurol.2022.04.011. Epub 2022 Apr 28.
To evaluate safety and tolerability of long-term treatment with diazepam nasal spray (Valtoco) for seizure clusters in patients aged six to 17 years.
The study enrolled patients aged six to 65 years with frequent seizure clusters. Age- and weight-based doses of diazepam nasal spray were administered; second doses were permitted if needed. Safety assessments included treatment-emergent adverse events (TEAEs).
Of 163 treated patients, 45 (27.6%) were aged six to 11 years and 33 (20.2%) were aged 12 to 17 years. Mean doses per month were 2.1 in the 6 to 11 subgroup and 2.4 in the 12 to 17 subgroup. Of 1634 seizure clusters in pediatric patients, 186 (11.4%) required a second dose of diazepam nasal spray within 24 hours of the first dose. Similar proportions of TEAEs and serious TEAEs were reported in 6 to 11 (91.1%, 40.0%) and 12 to 17 subgroups (81.8%, 30.3%), respectively. No serious TEAEs were considered treatment related, and no patients discontinued because of TEAEs. Treatment-related TEAEs were more frequent in the 12 to 17 subgroup; only epistaxis and somnolence occurred in two or more patients overall. TEAE rates were similar across subgroups that received concomitant clobazam (90.0%), received prior diazepam rectal gel (90.9%), and were administered less than two versus greater than or equal to two doses per month (87.2% for both) of diazepam nasal spray. Most survey respondents (88%) were satisfied or very satisfied with treatment.
In this long-term safety analysis in pediatric patients with seizure clusters, repeated doses of diazepam nasal spray demonstrated a safety profile consistent across subgroups. These data support the dosing guidelines for diazepam nasal spray according to age and weight for pediatric patients.
评估 6 至 17 岁患者癫痫发作群长期使用地西泮鼻喷雾剂（Valtoco）的安全性和耐受性。
该研究纳入了频繁癫痫发作群的 6 至 65 岁患者。给予基于年龄和体重的地西泮鼻喷雾剂剂量；如果需要，可给予第二剂。安全性评估包括治疗中出现的不良事件（TEAE）。
在 163 例接受治疗的患者中，45 例（27.6%）年龄为 6 至 11 岁，33 例（20.2%）年龄为 12 至 17 岁。6 至 11 岁亚组的平均每月剂量为 2.1，12 至 17 岁亚组为 2.4。在儿科患者的 1634 次癫痫发作群中，186 次（11.4%）在首次给药后 24 小时内需要第二次地西泮鼻喷雾剂给药。6 至 11 岁亚组（91.1%，40.0%）和 12 至 17 岁亚组（81.8%，30.3%）报告的 TEAEs 和严重 TEAEs 比例相似。没有严重的 TEAEs 被认为与治疗相关，也没有患者因 TEAEs 而停药。在 12 至 17 岁亚组中，治疗相关的 TEAEs 更为常见；只有鼻出血和嗜睡在两个或更多患者中出现。接受合并氯巴占（90.0%）、接受先前地西泮直肠凝胶（90.9%）以及每月接受少于 2 次与大于或等于 2 次地西泮鼻喷雾剂（均为 87.2%）治疗的亚组的 TEAE 发生率相似。大多数调查对象（88%）对治疗满意或非常满意。
在这项针对癫痫发作群的儿科患者的长期安全性分析中，重复使用地西泮鼻喷雾剂的安全性在各亚组中一致。这些数据支持了根据年龄和体重为儿科患者使用地西泮鼻喷雾剂的剂量指南。
