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Fibromyalgia (FM) is a chronic complex pain disorder that is multidimensional and exhibits heterogeneity requiring a long-term multidisciplinary approach to management. Many of the drugs used in the treatment of FM have been focused to the management of single symptoms; often such drugs fail to demonstrate acceptable efficacy in the majority of the patient population. Pregabalin is an α2-δ ligand that regulates the release and postsynaptic actions of neurotransmitters related to analgesic, anticonvulsant and anxiolytic properties. In randomized, double-blind, placebo-controlled studies, pregabalin has demonstrated an improvement in pain, sleep and fatigue symptoms associated with FM, as well as offering an improvement in parameters related to quality of life. Although the positive outcomes obtained with pregabalin support its use as an option for the management of FM, the efficacy was restricted to a selected patient population outside of the usual care setting. Current data do not allow an explanation where there are any limitations of pregabalin as a treatment of patients with FM, as to whether this is a deficiency of the drug or the process of assessment (e.g. assessment tools of FM, clinical trial design).
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