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Pregabalin Is Effective for Treatment of Fibromyalgia

Patients who received pregabalin had significant improvements in pain and sleep.

Pregabalin, an amino acid that is structurally similar to the neurotransmitter -aminobutyric acid, has analgesic, anticonvulsant, and anxiolytic properties. Small studies of very short duration suggest that pregabalin is effective for treatment of fibromyalgia.

In a multicenter randomized U.S. study, 748 patients with fibromyalgia received either placebo or pregabalin at daily doses of 300, 450, or 600 mg for 13 weeks. Before study entry, patients were required to discontinue almost all medicines (except acetaminophen) that could affect the outcomes measured. Compared with placebo recipients, patients treated at all dose levels of pregabalin had significant improvements in pain, sleep, and overall impression of symptoms. In general, improvements were greatest in the highest-dose group. Dizziness and somnolence were reported significantly more often by patients who received pregabalin, but the symptoms only rarely were severe enough to lead to discontinuation of the drug.

Comment: These results convincingly show that pregabalin is superior to placebo in the treatment of fibromyalgia, at least during the course of 13 weeks. The study could not determine whether pregabalin is superior to other therapies of proven benefit, such as tricyclic drugs, and whether the benefits extend beyond 13 weeks.

— Anthony L. Komaroff, MD

Published in Journal Watch General Medicine May 27, 2008

Citation(s):

Mease PJ et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008 Mar; 35:502.

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