OMC Clinical Research Center, UCLA School of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
University of Wisconsin, Madison, Wisconsin.
Pain Med. 2018 Mar 1;19(3):419-428. doi: 10.1093/pm/pnx091.
To evaluate the effect of baseline characteristics on the treatment response to pregabalin in fibromyalgia (FM) patients with depression.
Post hoc analysis from a randomized, double-blind, placebo-controlled, two-way crossover study of pregabalin (300 or 450 mg/day, twice daily).
A total of 193 FM patients taking an antidepressant for comorbid depression.
The effect of patient baseline characteristics on the treatment response to pregabalin vs placebo was assessed for the primary efficacy end point (mean pain score on an 11-point numeric rating scale). Variables were analyzed using a linear mixed effects model with sequence, period, and treatment as fixed factors, and subject within sequence and within subject error as random factors.
Pregabalin significantly improved mean pain scores vs placebo irrespective of age, duration of FM, number of prior FM medications, depression diagnosis, shorter-term depression (<10 years), prior or no prior opioid use, pain severity, anxiety severity, and sleep disruption severity (all P < 0.05). Compared with placebo, pregabalin did not significantly affect mean pain scores in patients with comorbid insomnia, irritable bowel syndrome, or gastroesophageal reflux disease; severe FM; a diagnosis of depression before FM, longer-term depression (≥ 10 years), more severe depression, or who were taking a high dose of antidepressant.
Pregabalin significantly improved mean pain scores when compared with placebo for the majority of baseline characteristics assessed in FM patients taking an antidepressant for comorbid depression.
评估基线特征对伴抑郁的纤维肌痛（FM）患者接受普瑞巴林治疗反应的影响。
普瑞巴林（300 或 450mg/天，每日两次）随机、双盲、安慰剂对照、两向交叉研究的事后分析。
共 193 例正在服用抗抑郁药治疗共病抑郁的 FM 患者。
采用线性混合效应模型，以序列、周期和治疗为固定因素，以受试者内序列和受试者内误差为随机因素，评估患者基线特征对普瑞巴林与安慰剂治疗反应的影响，主要疗效终点为（11 点数字评分量表上的平均疼痛评分）。
普瑞巴林显著改善了平均疼痛评分，与年龄、FM 持续时间、先前 FM 药物的数量、抑郁诊断、较短时间的抑郁（<10 年）、先前或无先前阿片类药物使用、疼痛严重程度、焦虑严重程度和睡眠中断严重程度无关（均 P<0.05）。与安慰剂相比，普瑞巴林对伴有共病失眠、肠易激综合征或胃食管反流病、严重 FM、FM 前诊断为抑郁症、长期抑郁（≥10 年）、更严重的抑郁或服用高剂量抗抑郁药的患者的平均疼痛评分没有显著影响。
在服用抗抑郁药治疗共病抑郁的 FM 患者中，与安慰剂相比，普瑞巴林显著改善了大多数基线特征的平均疼痛评分。
