• Stuart L Silverman, Miroslav Backonja, Lynne Pauer, Jaren Landen, Pritha Bhadra Brown, Joseph M Scavone, Richard Vissing, and Andrew Clair.
• OMC Clinical Research Center, UCLA School of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
• Pain Med. 2018 Mar 1; 19 (3): 419-428.

ObjectiveTo evaluate the effect of baseline characteristics on the treatment response to pregabalin in fibromyalgia (FM) patients with depression.DesignPost hoc analysis from a randomized, double-blind, placebo-controlled, two-way crossover study of pregabalin (300 or 450 mg/day, twice daily).SubjectsA total of 193 FM patients taking an antidepressant for comorbid depression.MethodsThe 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.ResultsPregabalin 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.ConclusionsPregabalin 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.

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