Two large, randomised, placebo-controlled studies presented at the inaugural conference of the World Association of Sleep Medicine (WASM; Berlin, Germany) in October demonstrate that pramipexole delivered both short-term and sustained efficacy in patients suffering from Restless Legs Syndrome (RLS)1,2 enrolled in these trials.
New data from a randomized, placebo-controlled "withdrawal" study1 show that discontinuation of pramipexole leads to rapid worsening of RLS in patients who had previously responded well to pramipexole therapy. In this study, RLS patients who responded to pramipexole treatment in a preceding 6-month open label treatment phase were randomized to receive either blinded pramipexole (n=78) or placebo (n=69) for 12 weeks. The primary endpoint of the study was assessment of Time to Worsening of RLS symptoms measured using the International RLS Rating Scale (IRLS) and the Clinical Global Impressions – Global Improvement (CGI-I) scale. The results showed:
In addition, in a fixed-dose study pramipexole demonstrated significant improvement in symptoms of RLS, when measured by two standard clinical assessment tools, when compared to placebo.2 This 12-week, placebo-controlled, randomized study sought to compare the efficacy and safety of pramipexole at different doses (0.25mg; 0.5mg and 0.75mg) when compared to placebo. After 12 weeks, patients who received pramipexole - across all three doses - experienced significantly greater improvements in symptoms of RLS compared to placebo. Three hundred and forty five patients were randomized and 339 patients were assessed at the end of 12 weeks for improvement in RLS symptoms using the IRLS and CGI-I scales.
In both studies pramipexole was generally well-tolerated and the most frequent adverse events were nausea, headache and fatigue.
Previous studies in RLS have reported rapid, statistically significant effects of pramipexole on RLS symptoms. The efficacy and safety of pramipexole for treatment of RLS has been studied from a starting dose of 0.125mg single dose per day and up to 0.75mg single dose per day.
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