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New data confirm Pramipexole delivers sustained efficacy for patients with Restless Legs Syndrome

Pressmeddelande   •   Okt 17, 2005 10:01 CEST

Randomised, placebo-controlled study shows discontinuation of pramipexole leads to rapid worsening of symptoms
17 October 2005
For medical media, outside the US only

Berlin/Germany, 17 October 2005 – Two new, randomised, placebo-controlled studies presented this week at the inaugural conference of the World Association of Sleep Medicine (WASM), demonstrate that pramipexole - the number one dopamine agonist prescribed for Parkinson’s Disease in the world – can deliver powerful and sustained efficacy in treating patients suffering from Restless Legs Syndrome (RLS).1,2 New data from a randomised, placebo-controlled pramipexole ‘withdrawal’ study1, report that when pramipexole is discontinued in patients who have been responding well for six months, this leads to rapid worsening of RLS symptoms - confirming for the first time, in a placebo-controlled trial, that pramipexole can deliver sustained, long-term symptom improvement for RLS patients beyond six months. New data from a 12-weeks, double-blind, fixed-dose study of 345 patients further confirm pramipexole can provide significantly greater improvement in symptoms of RLS, when measured by two standard clinical assessment tools, when compared to placebo.2

These new data add to the growing body of clinical evidence that pramipexole is a well tolerated treatment that can deliver rapid and significant relief from the symptoms of RLS and bring about significant improvements in patients’ quality of life. Clinical guidelines recommend dopamine agonists as first-line treatment for RLS, yet there has been limited data to confirm how long the treatments continue to relieve symptoms. Restless Legs Syndrome is a common, but poorly recognized and under-treated neurological disease that predominantly affects adults.

Proven for the first time: pramipexole delivers sustained efficacy
Although previous clinical evidence has provided a strong indication that pramipexole has the potential to deliver sustained efficacy, this evidence has been based on open-label or retrospective data. Professor Claudia Trenkwalder (Kassel, Germany) et al presented results from a prospective, placebo-controlled ‘randomised withdrawal’ study with pramipexole, which has shown for the first time that blinded discontinuation of pramipexole in RLS patients who are responding well, led to rapid worsening of symptoms in most patients1. The study set out to determine how 147 patients with moderate to severe RLS, who had already been receiving pramipexole treatment and who had responded well for six months, fared when they were randomised after six months to receive either a placebo treatment or to continue to receive pramipexole treatment. 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:
RLS patients who were randomised to continue treatment with pramipexole experienced a significantly longer time before their symptoms worsened than those patients who were randomised on to placebo (p