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Pregabalin Effectively Treats Restless Leg Syndrome

Treatment less likely to cause symptom worsening versus pramipexol (February 13)

A report in the February 13 issue of the New England Journal of Medicine confirms previous studies suggesting that long-term treatment with the type of drugs commonly prescribed for restless leg syndrome (RLS) can cause a serious worsening of the condition in some patients.

The year-long study found that pregabalin — which is FDA-approved to treat nerve pain, seizures, and other conditions — was effective in reducing RLS symptoms and was much less likely to cause symptom worsening than pramipexole, one of several drugs that activate the dopamine neurotransmission system and are FDA approved for the treatment of RLS.

Conducted in the U.S. and Europe, the study enrolled more than 700 adults experiencing moderate-to-severe RLS symptoms 15 or more nights a month for 6 months or longer. All participants had stopped taking medications for RLS for at least 2 weeks before beginning the study.

For the first 12 weeks of the study, the participants were randomly assigned to one of four treatment groups that received daily doses of pramipexole 0.25 mg, pramipexole 0.5 mg, pregabalin 300 mg, or placebo. After the first phase, all participants receiving placebo were randomly assigned to one of the active-drug groups for the remaining 40 weeks of the study.

At the end of the 12-week, placebo-controlled phase, patients receiving pregabalin experienced significantly greater symptom improvement compared with those receiving placebo, as did those treated with the higher pramipexole dose. Over the full study period, only 2% of those receiving pregabalin experienced symptom improvement, compared with almost 8% of those receiving pramipexole 0.5 mg and approximately 5% of those receiving pramipexole 0.25 mg.

Source: Massachusetts General Hospital; February 12, 2014.

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