Pregabalin: its efficacy, safety and tolerability profile in fibromyalgia syndrome.

Fibromyalgia syndrome (FMS) is characterized by chronic widespread pain and accompanied by a variety of other symptoms such as fatigue, sleep dysfunction, depression, anxiety and cognitive disturbance. Current guidelines recommend tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors) as first-line therapies to treat the multiple symptom domains. Until recently, however, there were no licensing authority approved treatments for FMS. The alfa 2 delta modulator pregabalin has anxiolytic, anticonvulsant and antinociceptive properties which has prompted its investigation in FMS. In a series of short-term randomized, double-blind, placebo-controlled trials of 8-14 weeks duration, pregabalin proved effective in reducing the pain and accompanying symptoms of FMS and improved quality of life domains. A 6-month double-blind, placebo-controlled trial demonstrated the durability of its effects on pain and a variety of secondary measures such as fatigue and sleep disturbance. Overall, pregabalin was well tolerated with no new adverse events emerging that have not been reported with its use in other indications.