PT - JOURNAL ARTICLE AU - Lesley M. Arnold AU - Piercarlo Sarzi-Puttini AU - Pierre Arsenault AU - Tahira Khan AU - Pritha Bhadra Brown AU - Andrew Clair AU - Joseph M. Scavone AU - Joseph Driscoll AU - Jaren Landen AU - Lynne Pauer TI - Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study AID - 10.3899/jrheum.141196 DP - 2015 Jun 01 TA - The Journal of Rheumatology PG - jrheum.141196 4099 - http://www.jrheum.org/content/early/2015/05/25/jrheum.141196.short 4100 - http://www.jrheum.org/content/early/2015/05/25/jrheum.141196.full AB - Objective To assess pregabalin efficacy and safety in patients with fibromyalgia (FM) with comorbid depression taking concurrent antidepressant medication. Methods This randomized, placebo-controlled, double-blind, 2-period, 2-way crossover study was composed of two 6-week treatment periods separated by a 2-week taper/washout phase. Patients with FM (aged ≥ 18 yrs) taking a stable dose of a selective serotonin reuptake inhibitor (SSRI) or a serotonin/norepinephrine reuptake inhibitor (SNRI) for depression were randomized 1:1 to receive pregabalin/placebo or placebo/pregabalin (optimized to 300 or 450 mg/day). Antidepressant medication was continued throughout the study. The primary efficacy outcome was the mean pain score on an 11-point numerical rating scale. Secondary efficacy outcomes included measures of anxiety, depression, patient function, and sleep. Results Of 197 patients randomized to treatment, 181 and 177 received ≥ 1 dose of pregabalin and placebo, respectively. At baseline, 52.3% of patients were taking an SSRI and 47.7% an SNRI, and mean pain score was 6.7. Mean pain scores at endpoint were statistically significantly reduced with pregabalin (least squares mean difference from placebo –0.61, 95% CI –0.91 – –0.31, p = 0.0001). Pregabalin significantly improved Hospital Anxiety and Depression Scale-Anxiety (difference –0.95, p < 0.0001) and -Depression (difference –0.88, p = 0.0005) scores, Fibromyalgia Impact Questionnaire total score (difference –6.60, p < 0.0001), and sleep quality (difference 0.57, p < 0.0001), but not EuroQol 5-Dimensions score (difference 0.02, p = 0.3854). Pregabalin safety was consistent with previous studies and current product labeling. Conclusion Compared with placebo, pregabalin statistically significantly improved FM pain and other symptoms in patients taking antidepressant medication for comorbid depression. ClinicalTrials.gov identifier: NCT01432236.