April 29, 2009 / 8:28 PM / in 8 years

Epileptic drug calms restless legs, improves sleep

NEW YORK (Reuters Health) - The anti-seizure drug pregabalin (Lyrica) appears to help patients with restless legs syndrome get a better night’s sleep. That’s according to the findings of a clinical trial presented today at the annual meeting of the American Academy of Neurology.

Pregabalin, which is approved for the treatment epilepsy, neuropathic pain, generalized anxiety and fibromyalgia, was well tolerated by patients with restless legs syndrome and “is a promising alternative to current treatments because of its superior effects on quality of sleep,” Dr. Diego Garcia-Borreguero, director of the Sleep Research Institute in Madrid, Spain, noted in a meeting statement.

The study involved 58 patients with restless legs syndrome of unknown origin. After 2 weeks on a placebo, 30 patients were assigned to receive pregabalin (150 to 600 milligrams daily) and 28 remained on the placebo for 12 weeks. Restless legs syndrome severity was determined periodically using the International Restless Legs Syndrome Rating Scale, as well as other disease severity measures; sleep studies were performed at the beginning of the study and again after 12 weeks.

According to Garcia-Borreguero and colleagues, the change in International Restless Legs Syndrome Rating Scale scores was significantly “more pronounced” with pregabalin than with placebo. With pregabalin, scores on this disease severity index declined from 19.8 to 6.8; with placebo, scores declined from 21.5 to 11.2.

Similar findings were obtained with other disease severity assessments, according to the investigators.

In addition, 63.3 percent of pregabalin-treated patients had remission of restless legs syndrome symptoms while taking the drug, at an average daily dose of 337 milligrams. In comparison, only 28.6 percent of placebo-treated patients achieved remission.

Pregabalin treatment also improved the sleep patterns in restless legs syndrome patients, who had a significant increase in time spent in deep slow wave Stage 3 sleep and a decrease in time spent in lighter stage 1 or 2 sleep, compared with the patients on placebo.

Due to its superior therapeutic effects on sleep, Garcia-Borreguero and colleagues conclude, pregabalin is a promising alternative to current drug treatments for restless legs syndrome.

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