Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study.

Lesley M Arnold Piercarlo Sarzi-Puttini Pierre Arsenault Tahira Khan Pritha Bhadra Brown Andrew Clair Joseph M Scavone Joseph Driscoll Jaren Landen Lynne Pauer

J Rheumatol

From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.

Published: July 2015

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.

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http://dx.doi.org/10.3899/jrheum.141196	DOI Listing

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