TY - JOUR T1 - Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study JF - The Journal of Rheumatology JO - J Rheumatol SP - 1237 LP - 1244 DO - 10.3899/jrheum.141196 VL - 42 IS - 7 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 Y1 - 2015/07/01 UR - http://www.jrheum.org/content/42/7/1237.abstract N2 - 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. ER -