Background/Purpose: Fibromyalgia (FM) is characterized by chronic widespread pain and often associated with mood disorders including depression. Approximately 50–70% of FM patients have a lifetime history of co-morbid depression and ~25% have a history of antidepressant therapy. Pregabalin (PGB) is approved for the treatment of FM in the US, Japan and other countries. Because prior PGB FM clinical trials excluded the concomitant use of antidepressant medications, information about the efficacy and safety of adding PGB to antidepressant medications in patients with depression and FM is lacking. 

Methods: This was a randomized, 2-way crossover, double-blind, placebo-controlled study of PGB in FM subjects with co-morbid depression receiving concurrent antidepressant medication for the treatment of depression with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Patients were aged ≥18 years, met the 1990 American College of Rheumatology criteria for FM, had a mean numeric rating scale (NRS) pain score of ≥4 (NRS scored from 0–10), a documented diagnosis of depression, and were being treated with a stable dose of a single SSRI or SNRI for the 2 months prior to randomization. All patients were randomized 1:1 to placebo or PGB (optimized to 300 or 450 mg/d) for the first 6-week treatment period (3 weeks dose optimization, 3 weeks fixed dose for each treatment period), and then switched to the alternate regimen for the second 6-week treatment period. Treatment periods were separated by a 2-week, single-blind taper/placebo washout. Stable antidepressant medication was continued throughout the study. The primary efficacy endpoint was mean pain score based on the mean of the last 7 daily pain scores. 

Results: A total of 197 patients (93% female, 94% white, mean age 50 years) were randomized to treatment; 181 received ≥1 dose of treatment with PGB and 177 placebo. The mean time since diagnosis of depression was 12.3 years and the baseline mean Hospital Anxiety and Depression Scale – Depression score was 8.0, reflecting mild depression. At baseline, 52.3% were taking an SSRI, 47.7% an SNRI, and the mean pain score was 6.7. At the end of treatment, the least squares (LS) mean (SE) pain score was significantly lower with PGB (4.84 [0.15]) than with placebo (5.45 [0.16]) (LS mean difference -0.61; 95% confidence interval -0.91 to -0.31; p=0.0001). Treatment emergent adverse events (AEs) were reported in 77.3% and 59.9% of patients receiving PGB and placebo, respectively. The most frequently reported AEs with PGB were dizziness (28.2%) and somnolence (19.9%). A total of 4 serious AEs were reported (3 with PGB and 1 with placebo), none of which were considered related to treatment. In patients receiving PGB, 6.1% discontinued treatment due to AEs, compared with 3.4% receiving placebo. 

Conclusion: PGB significantly improved FM pain in patients with FM and co-morbid depression receiving concurrent antidepressant medication, when compared with placebo. The safety profile of PGB in this population was consistent with previous studies and current product labelling.

---

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-pregabalin-in-patients-with-fibromyalgia-and-co-morbid-depression-receiving-concurrent-antidepressant-therapy-a-randomized-2-way-crossover-double-blind-placebo-controlled-st/