by Martha Kerr

Last Updated: 2008-04-16 14:49:26 -0400 (Reuters Health)

NEW YORK (Reuters Health) – Pregabalin (Lyrica) provides significant pain relief in fibromyalgia, regardless of the degree of symptoms of anxiety and depression.

The finding reinforces evidence that fibromyalgia is the result of neurological changes and is not driven by emotional events, investigators reported at the 60th annual meeting of the American Academy of Neurology in Chicago.

Results of pooled data from three trials involving a total of 2022 patients who met the American College of Rheumatology’s criteria for fibromyalgia were presented at the meeting by Dr. Lesley Arnold of the University of Cincinnati, Ohio. Median duration of disease was 9.5 years.

At baseline, the median self-assessment score for pain was 6.9 on a 10-point visual analog scale (VAS). In addition, 38% reported moderate-to-severe anxiety and 27% reported moderate-to-severe depression.

Patients were assigned to pregabalin 150 mg, 300 mg, 450 mg or 600 mg, or placebo, daily and followed for 8 to 14 weeks.

Pregabalin in all dosages except 150 mg produced significant pain relief, Dr. Arnold told Reuters Health. "The presence of anxiety and depression at baseline did not affect pain relief." This indicates that the pain of fibromyalgia is a specific neurological event separate from the psychiatric symptoms associated with the disease.

"There was a 50% improvement in pain in one-third of patients, and there was 30% improvement in another third of patients," Dr. Arnold said. "Most patients felt overall improvement" in the global impression of pain but not in feelings of anxiety or depression.

"The 600 mg dose provided the greatest pain relief but was also associated with the highest incidence of adverse effects," primarily dry mouth and weight gain, but also mild-to-moderate dizziness and somnolence, Dr. Arnold reported.

Pregabalin is an alpha-2-delta ligand that is thought to bind to a subunit of voltage-gated calcium channel ions in neurons, Dr. Arnold said, but its exact mechanism of action in fibromyalgia is unknown.

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