Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan, USA.
Arthritis Care Res (Hoboken). 2012 Apr;64(4):597-606. doi: 10.1002/acr.21595.
To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.
We performed a randomized, double-blind, placebo-controlled, 2-period crossover PSG study. Patients ages ≥18 years with fibromyalgia satisfied subjective and objective sleep disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300-450 mg/day) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods. In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period. The primary end point was the difference in sleep maintenance defined by PSG-recorded wake after sleep onset (WASO; minutes) between 4 weeks of treatment with pregabalin and with placebo. Other PSG measures; patient-rated sleep, tiredness, and pain; and tolerability were assessed.
Of 119 patients randomized (103 women [86.6%], mean age 48.4 years), 102 (85.7%) completed both periods. Patients treated with pregabalin showed a reduction in PSG-determined WASO versus treatment with placebo (week 4 difference: -19.2 minutes [95% confidence interval (95% CI) -26.7, -11.6]; P < 0.0001). Pain score improved (decreased) with pregabalin versus placebo treatment at all 4 weeks (week 4 difference: -0.52 [95% CI -0.90, -0.14]; P = 0.0084). Modest (ρ = <0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. Frequently reported all-causality adverse events (pregabalin versus placebo) were: dizziness (30.4% versus 9.9%), somnolence (20.5% versus 4.5%), and headache (8.9% versus 8.1%).
Patients with fibromyalgia treated with pregabalin had statistically significant and meaningful improvements in sleep, as assessed by PSG. Patients with fibromyalgia also reported decreased daily pain. Pregabalin was well tolerated.
评估普瑞巴林对纤维肌痛患者睡眠多导图（PSG）测量和患者自评睡眠、疲劳和疼痛的影响。
我们进行了一项随机、双盲、安慰剂对照、2 期交叉 PSG 研究。在随机分组前，年龄≥18 岁且符合主观和客观睡眠障碍标准的纤维肌痛患者纳入研究。符合条件的患者按 1:1 随机分为普瑞巴林（300-450mg/天）或安慰剂组进行交叉周期 1，然后在周期 2 中交换。每个交叉周期包括剂量调整和维持阶段，两个周期之间有 2 周的减量/洗脱期。在筛选和每个交叉周期结束时连续记录 2 个晚上的实验室 PSG。主要终点是普瑞巴林治疗 4 周与安慰剂治疗之间 PSG 记录的睡眠维持定义的差异，即睡眠潜伏期后觉醒（WASO；分钟）。还评估了其他 PSG 测量、患者自评睡眠、疲劳和疼痛；以及耐受性。
119 名随机患者（103 名女性[86.6%]，平均年龄 48.4 岁）中，102 名（85.7%）完成了两个周期。与安慰剂治疗相比，接受普瑞巴林治疗的患者 PSG 确定的 WASO 减少（第 4 周差异：-19.2 分钟[95%置信区间（95%CI）-26.7，-11.6]；P<0.0001）。与安慰剂治疗相比，疼痛评分在所有 4 周均有改善（下降）（第 4 周差异：-0.52[95%CI-0.90，-0.14]；P=0.0084）。在 PSG 睡眠评估和疼痛及睡眠质量评分之间发现了适度（ρ<0.3）但具有统计学意义的相关性。常报告的所有因果关系不良事件（普瑞巴林与安慰剂）为：头晕（30.4%与 9.9%）、嗜睡（20.5%与 4.5%）和头痛（8.9%与 8.1%）。
接受普瑞巴林治疗的纤维肌痛患者的睡眠在 PSG 评估中具有统计学意义和显著改善。纤维肌痛患者的日常疼痛也有所减轻。普瑞巴林耐受性良好。
