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Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study
- Source :
- The Journal of rheumatology. 42(7)
- Publication Year :
- 2015
-
Abstract
- 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.
- Subjects :
- Adult
Male
Fibromyalgia
medicine.drug_class
Serotonin reuptake inhibitor
Immunology
Pregabalin
Placebo-controlled study
Placebo
Rheumatology
Norepinephrine reuptake inhibitor
Double-Blind Method
medicine
Immunology and Allergy
Humans
Drug Interactions
Serotonin–norepinephrine reuptake inhibitor
Analgesics
Depressive Disorder
Cross-Over Studies
Dose-Response Relationship, Drug
business.industry
Middle Aged
medicine.disease
Crossover study
Antidepressive Agents
Treatment Outcome
Anesthesia
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 0315162X
- Volume :
- 42
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- The Journal of rheumatology
- Accession number :
- edsair.doi.dedup.....7ed23d743f161868e9c34889c26d6ce3