Pregabalin for the treatment of fibromyalgia syndrome: Results of a randomized, double‐blind, placebo‐controlled trial

Abstract

Results. Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo (؊0.93 on a 0-10 scale) (P < 0.001), and significantly more patients in this group had >50% improvement in pain at the end point (29%, versus 13% in the placebo group; P ‫؍‬ 0.003). Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality, fatigue, and global measures of change. Pregabalin at 450 mg/day improved several domains of health-related quality of life. Dizziness and somnolence were the most frequent adverse events. Rates of discontinuation due to adverse events were similar across all 4 treatment groups.Conclusion. Pregabalin at 450 mg/day was efficacious for the treatment of FMS, reducing symptoms of pain, disturbed sleep, and fatigue compared with placebo. Pregabalin was well tolerated and improved global measures and health-related quality of life.Fibromyalgia syndrome (FMS) affects ϳ3-6 million people in the US, with a prevalence in the general population estimated at 2% and an increased frequency among women (1). A characteristic symptom complex of chronic widespread musculoskeletal pain, disordered sleep, and fatigue associated with a lowered pain threshold is shared among those patients meeting the American College of Rheumatology (ACR) classification criteria for FMS (2). The etiology and pathogenesis of FMS are not well understood, but they are probably

Sleep Disorders in Fibromyalgia Syndrome

“…It is demonstrated that all these medications can positively influence sleep [58][59][60][61][62]. Duloxetine and milnacipram delay the onset and reduce the duration of REM sleep, improving sleep continuity and quality [63].…”

“…Duloxetine and milnacipram delay the onset and reduce the duration of REM sleep, improving sleep continuity and quality [63]. Pregabalin has beneficial effects on pain, fatigue and quality of sleep [58]. Sleep improvement could be direct or due to the reduction in pain or both [59,62,64].…”

Use of Antiepileptic Drugs for Nonepileptic Conditions: Psychiatric Disorders and Chronic Pain

“…Other benefits included improvement in sleep quality and fatigue. 89 Pregabalin is the newest available anticonvulsant and it has clearly been shown to be an effective analgesic.…”

The Role of Depression in Chronic Musculoskeletal Pain

“…It should also be possible to treat the pain and see the depression improve or vice versa. That did not happen when effective analgesics for central sensitization-related pain [but lacking antidepressant activity] were used to treat patients with FMS (8,9). Depression emerged or persisted unchanged despite significant relief of the chronic pain.…”