在 3 项开放性延伸研究中，对患有纤维肌痛的患者进行长达 1 年的普瑞巴林治疗的安全性概况和耐受性。
Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia.
机构信息
Women's Health Research Program, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Ohio, USA.
出版信息
Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.
BACKGROUND
Pain relief and an acceptable safety profile have been reported in randomized controlled trials (RCTs) of pregabalin in the treatment of fibromyalgia (FM) for up to 14 weeks.
OBJECTIVE
To evaluate the safety profile and tolerability of pregabalin (75-300 mg BID) treatment for up to 1 year in patients with FM.
METHODS
Twelve-week data were pooled from 3 open-label extension studies of pivotal RCTs. Study 1 was a 1-year extension of a 13-week RCT, and studies 2 and 3 were 12-week extensions of 14-week RCTs. The 1-year data were separately evaluated. The open-label data are summarized using descriptive statistics.
RESULTS
Overall, 1206 patients (92.4% female) with a mean (SD) age of 48.8 (10.7) years received open-label extended pregabalin treatment. A total of 119 of 1206 patients (9.9%) permanently discontinued study participation due to treatment-emergent adverse events (all causality) at 12 weeks (pooled data) and 53 of 429 (12.4%) within 1 year. Consistent with previous RCTs, the most commonly reported treatment-emergent adverse events with open-label pregabalin treatment were dizziness, somnolence, headache, peripheral edema, and increased weight. The highest incidence rates in the pooled 12-week data were for dizziness (214 of 1206; 17.7%) and somnolence (96 of 1206; 8.0%). In ratings of severity (mild, moderate, severe), most were reported as mild to moderate. The mean (SD) change in patient-reported visual analog scale pain scores (0-100) from the open-label baseline to the end of treatment was -21 (30.5) in study 1 (1 year), -26.7 (28.8) in study 2 (12 weeks), and -20.1 (26.8) in study 3 (12 weeks).
CONCLUSIONS
The data from these extension studies suggest that the adverse event safety profile and tolerability of patients with FM treated with open-label pregabalin (75-300 mg BID) for up to 1 year were stable and were consistent with those of previous studies. ClinicalTrials.gov identifiers: NCT00151528 (A0081057 [study 1]), NCT00282997 (A0081078 [study 2]), and NCT00346034 (A0081101 [study 3]).
背景
在为期 14 周的纤维肌痛（FM） pregabalin 治疗随机对照试验（RCT）中，已报道 pregabalin 具有缓解疼痛和可接受的安全性特征。
目的
评估 pregabalin（75-300mg BID）治疗 FM 患者长达 1 年的安全性特征和耐受性。
方法
将 3 项关键 RCT 的开放性扩展研究的 12 周数据进行汇总。研究 1 是一项为期 13 周 RCT 的 1 年扩展研究，研究 2 和研究 3 分别是 14 周 RCT 的 12 周扩展研究。分别评估了 1 年的数据。使用描述性统计数据汇总开放性数据。
结果
总体而言，1206 名患者（92.4%为女性）接受了开放性扩展 pregabalin 治疗，平均（SD）年龄为 48.8（10.7）岁。在 12 周（汇总数据）时，由于治疗引起的不良事件（所有病因），共有 1206 名患者中的 119 名（9.9%）永久停止研究参与，而在 1 年内，429 名患者中的 53 名（12.4%）永久停止研究参与。与之前的 RCT 一致，接受开放性 pregabalin 治疗的患者最常报告的治疗出现的不良事件是头晕、嗜睡、头痛、外周水肿和体重增加。在汇总的 12 周数据中，头晕（1206 例患者中 214 例；17.7%）和嗜睡（1206 例患者中 96 例；8.0%）的发生率最高。在严重程度评分（轻度、中度、重度）中，大多数报告为轻度至中度。从开放性基线到治疗结束时，患者报告的视觉模拟量表疼痛评分（0-100）的平均（SD）变化在研究 1（1 年）中为-21（30.5），在研究 2（12 周）中为-26.7（28.8），在研究 3（12 周）中为-20.1（26.8）。
结论
这些扩展研究的数据表明，纤维肌痛患者接受开放性 pregabalin（75-300mg BID）治疗长达 1 年的不良事件安全性特征和耐受性是稳定的，与之前的研究一致。临床试验标识符：NCT00151528（A0081057 [研究 1]），NCT00282997（A0081078 [研究 2]）和 NCT00346034（A0081101 [研究 3]）。
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