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

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.

• Authors: Lesley M Arnold, Piercarlo Sarzi-Puttini, Pierre Arsenault, Tahira Khan, Pritha Bhadra Brown, Andrew Clair, Joseph M Scavone, Joseph Driscoll, Jaren Landen, Lynne Pauer
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 42 Issue 7 Pg. 1237-44 (Jul 2015) ISSN: 0315-162X [Print] Canada
• PMID: 26034150 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Antidepressive Agents
• Pregabalin

Topics

• Adult
• Analgesics (adverse effects, therapeutic use)
• Antidepressive Agents (therapeutic use)
• Cross-Over Studies
• Depressive Disorder (complications, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Interactions
• Female
• Fibromyalgia (complications, drug therapy)
• Humans
• Male
• Middle Aged
• Pregabalin (adverse effects, therapeutic use)
• Treatment Outcome